TECHNICAL SUPPORT DOCUMENT (TSD)

     FOR THE STATE OF MARYLAND 111(d)/129 PLAN

  REVISION (#1) FOR LARGE MUNICIPAL WASTE

COMBUSTORS (MWC) UNITS

Submitted by the Maryland Department of the Environment, Shari T. Wilson, Secretary

  on October 24, 2007

TSD Prepared February 2007 by

James B. Topsale,P.E.

Air Quality Analysis Branch, 3AP22

U.S. Environmental Protection Agency, Region 3

1650 Arch Street

Philadelphia, Pennsylvania 19103

(215) 814-2190

_______________/S/___________________

Reviewed by Walter K. Wilkie, Chief

Air Quality Analysis Branch

__  3/6/08_________

Date Signed

                       TABLE OF CONTENTS

	Page

I.	INTRODUCTION	  3

II.  BACKGROUND	  3

A.	Federal Requirements for MWC 111(d)/129 Plans	  3

B.	MWC Emissions	 4

C.	Applicability . . . . . . . . . . . . . . . . . . . 	4

D.	Designated Facilities . . . . . . . . . . . . . . . 	4

III. CRITERIA USED IN PLAN EVALUATION	 5

IV.  PLAN REVISION REVIEW . . . . . . . . . . . . . . . . .	  5

A.	Evaluation of the Maryland Plan against the requirements of 40 CFR Part 60, Subpart Cb, Sections 60.30b through 60.39b	5

     B.   Evaluation of the Maryland Plan against the                      requirements of 40 CFR Part 60, Subpart B, Sections              60.23 through 60.26	12

V.	CONCLUSION	 22

I.  INTRODUCTION

This action approves the Maryland 111(d)/129 plan revision for controlling municipal waste combustor (MWC) emissions from existing large MWC units.  The plan revision was submitted on October 24, 2007 to satisfy the requirements of Sections 111(d) and 129 of the Clean Air Act (CAA), and regulations promulgated thereunder.  After an August 8, 2007 public hearing on the plan revision, it was adopted by the Maryland Department of the Environment (MDE)on September 12, 2007 and became effective on October 8, 2007. The original plan was approved by EPA in the Federal Register on April 23, 1999.  (64 FR 19919)

II.  BACKGROUND

A.	Federal Requirements for MWC 111(d)/129 Plans

Section 111(d) of the CAA requires that "designated" pollutants controlled under standards of performance for new stationary sources by Section 111(b) of the CAA must also be controlled at existing sources in the same source category. Also, Section 129 of the CAA specifically addresses solid waste combustion. It requires EPA to establish emission guidelines (EG) for MWC units and requires states to develop state plans for implementing the promulgated EG. The Part 60, Subpart Cb, EG for MWC units address both Section 111(d) and Section 129 requirements. Section 129 requirements override certain aspects of Section 111(d).

On December 19, 1995, pursuant to Sections 111 and 129 of the CAA, EPA promulgated new source performance standards (NSPS) applicable to new MWCs (i.e., constructed after September 20, 1994) and EG applicable to existing MWCs.  The NSPS and EG are codified at 40 CFR Part 60, Subparts Eb and Cb, respectively.  See 60 FR 65387.  Subparts Cb and Eb regulate the following air pollutants:  particulate matter, opacity, sulfur dioxide, hydrogen chloride, oxides of nitrogen, carbon monoxide, lead, cadmium, mercury, and dioxins and dibenzofurans.

Section 129(a)(5) of the CAA requires EPA to conduct a 5-year review of the NSPS and EG and revise both, if appropriate. As a result, in the May 10, 2006 edition of the Federal Register, EPA adopted revised section 129 rules for large MWC units.

Accordingly, the MDE has submitted the required State plan revision to EPA for review and approval.  State Plan revisions must be (at least as protective( as the EG revisions.  The procedures for adoption and submittal of State Plans and revisions are codified in 40 CFR Part 60, Subpart B.

B.	MWC Emissions

Emissions from MWCs contain organics (dioxin/furans), metals (cadmium, lead, mercury, particulate matter, opacity), and acid gases (hydrogen chloride, sulfur dioxide, and nitrogen oxides).  These pollutants can cause adverse effects to the public health and the environment. Dioxin, lead and mercury can bioaccumulate in the environment. Acid gases contribute to the acid rain that damages lakes and harms forests and buildings. Furthermore,

nitrogen oxides emissions can contribute to ground level ozone, which is associated with a number of adverse health and environmental effects.

C.  Applicability

The large MWC EG, Subparts Cb, apply to each MWC unit with a combustion capacity greater than 250 TPD of MSW for which construction was commenced on or before September 20, 1994. Excluded from this applicability under Subpart Cb are 1) small qualifying power production facilities, as defined in Section 3(17)(C) of the Federal Power Act; 2) qualifying cogeneration facilities, as defined in Section 3(18)(B) of the Federal Power Act; 3) any unit combusting a single-item waste stream of tires; 4) material recovery facilities (including primary and secondary smelters); 5) cofired combustors, as defined in the MWC NSPS, Subpart Eb; 6) air curtain incinerators that combust 100% yard waste; and 7) pyrolysis/combustion units that are an integrated part of a plastics/rubber recycling unit, as defined in Subpart Eb. The scope of these exemptions is discussed in more detail under the MWC rule preamble (60 FR 65391 and 62 FR 45117) and Section 60.32b of the MWC EG, as amended.  The MDE MWC regulation does not identify these exclusions.

D.  Designated Facilities

The MDE has identified two(2) facilities with individual MWC units having combustion capacities greater than 250 TPD. The first facility, the Wheelabrator Baltimore, L.P. (formerly known as Baltimore Resco) plant has a total capacity of 2,250 TPD, consisting of three 750 TPD units each. The second facility, the Montgomery County Resource Recovery Facility (formerly known as Ogden Martin Systems of Montgomery County) plant, has a total capacity of 1,800 TPD.

III.  CRITERIA USED IN PLAN EVALUATION

The Maryland 111(d)Plan revision was reviewed against the following criteria:

     1.  40 CFR Part 60, Subparts Cb, and Eb, as amended May 10,          2006, Sections 60.30b through 60.39b.

2.  40 CFR Part 60, Subpart B, as amended, Sections 60.23            through 60.26.

3.  EPA Document entitled: " Municipal Waste Combustion:             Summary of the Requirements for Section 111(d)/129 State          Plans for Implementing the Municipal Waste Combustor             Emission Guidelines", July 1996.

IV.  PLAN REVISION REVIEW

A. Evaluation of the Maryland Plan revision against the requirements of 40 CFR Part 60, Subpart Cb, Sections 60.30b through 60.39b, as amended May 10, 2006.

(60.30b, Scope and Delegation of Authority

EPA retains those authorities as listed in the EG at 40 CFR 60.30b(b) and the related NSPS provisions at 40 CFR 60.50b(n).

(60.31b  Definitions (COMAR <IP_ADDRESS> and .02)

COMAR 26.11.08 reference to definitions is complete and consistent with those given in (60.31b, and the applicable subpart Eb (60.51b definitions, as amended. See the July 6, 2007 Maryland Register notice, 26.11.08 Control of Incinerators, Statement of Purpose.

(60.32b Designated facilities (COMAR <IP_ADDRESS>)

COMAR 26.11.08 is as protective as the requirements under 60.32b, as amended.

(60.33b Emission MACT requirements for MWC metals, acid gases, organics, NOx.

                               Maryland COMAR <IP_ADDRESS>A.(2) MACT Requirements - Region III Review

Pollutant or Parameter

MD Emission Standards (Large MWCP)

Emissions Stds.

(As Protective(

Comment(s)

CO (ppmv, 4hr blk)

100

Yes

Total

Dioxin/Furans (ng/dscm)

ESP based controls - 35; non ESP based controls - 30

Yes

See note 2 below.

Part. Matter (gr/dscf)

0.01

Yes

Opacity (%)

10

Yes

Cadmium (ug/dscm)

35

Yes

.

Lead (ug/dscm)

400

Yes

.

Mercury (mg/dscm)

0.05 or 85% red. (less stringent)

Yes

Note: 1.  All concentrations are based on 7% O2 dry basis, except as provided in 40 CFR 60.58b(6).

          2.  Revised standards are highlighted in (bold( print; compliance required by 4/28/09.

(60.33b Emission MACT requirements for MWC metals, acid gases, organics, NOx  (Continued).

                          Maryland COMAR <IP_ADDRESS> A.(2)  MACT Requirements - Region III Review

Pollutant or Parameter

MD Emission Standards (Large MWCP)

Emissions Stds.

(As Protective(

Comment(s)

SO2 (ppmv, 24-hr daily geometric mean % red.)

29 or 75% red. (less stringent)

Yes

HCl (ppmv)

29 or 95% red. (less stringent)

Yes

NOx (ppmv)

205 ppmv

Yes

Load (% steam)

NTE 110% of max. load during last dioxin perf. test

Yes

Temperature (4 hr blk. @ part. matter inlet control)

NTE more than  17 0C of max temp. during last dioxin perf. test

Yes

Fugitive Ash Emissions (VE % of time)

VE < 5% of time @ ash transfer points

Yes

(60.34b Emission guidelines for MWC operating practices (COMAR <IP_ADDRESS>A.(2)):

COMAR <IP_ADDRESS>A(2) is consistent with 60.34b, as amended.

(60.35b Emission guidelines for MWC operator training and certification (COMAR <IP_ADDRESS>):

              Maryland COMAR <IP_ADDRESS> Operator Training & Certification Requirements - Region III Review

EPA 60.54b Training & Certification Req(mts - Summary

MD

Requirement (s)

Requirements.

(As Protective(

Comment(s)

 (a) Chief facility operator (CFO) and shift supervisor (SS) provisional certification through ASME or state program

.09B.- Requires operators to be certified under state program,

Yes

(b) CFO and SS full certification by 12/19/96

See above

Yes

Under .09B, trained operators were required after July 1, 1990 for facility operation.

(c) Need one fully, or scheduled fully certified CFO or SS at operating plant

.09B - Prohibits MWC operation without a certified operator

Yes

Unlike the EPA operator stand-in provision, .09B requires that the incinerator be operated only when a trained operator is on duty.  This is consistent  with subpart B, 40 CFR 60.24(g)

(d) Completion of EPA or State MWC operator course by 12/19/96

Training course completion required by 11/9/90

Yes

(e)  Yearly update of site-specific O/M manual by owner/operator

Annually

Yes

See <IP_ADDRESS>H(2)

(f) Periodic Review of the O/M manual with plant operating staffs

Annually

Yes

See <IP_ADDRESS>B.(2) and D(1)

(g) Readily accessible O/M manual

On-site

Yes

See <IP_ADDRESS>H(1)

MDE operator training and certification requirements of  COMAR <IP_ADDRESS> were approved with the original plan in lieu of ASME requirements.

(60.36b Emission guidelines for MWC fugitive ash emissions (COMAR <IP_ADDRESS> A(2)):

COMAR <IP_ADDRESS>A(2) is as protective as the requirements of 60.36b.

(60.37b Emissions guidelines for air curtain incinerators:

Based on the submitted source inventory, Maryland does not have any air curtain incinerators.

(60.38b Compliance and performance testing.

          Maryland COMAR <IP_ADDRESS> A(2), B, and C Compliance & Performance Requirements - Region III Review

Pollutant or Parameter

MD Performance & Compliance Test Req’ments

Perf. & Compl. Test Requirements

(As Protective(

Comment(s)

CO (ppmv, 4hr blk)

CEMS

Yes

Dioxin/Furans (ng/dscm)

EPA M23

Yes

Part. Matter (gr/dscf)

EPA M5

Yes

Certified CEMS option may be used in lieu of stack test.

Opacity

EPA M9 & COMS

Yes

EPA M9 is controlling.

Cadmium (mg/dscm)

EPA M29

Yes

Certified CEMS option may be used in lieu of stack test.

Lead (mg/dscm)

EPA M29

Yes

Certified CEMS option may be used in lieu of stack test.

Mercury (mg/dscm)

EPA M29

Yes

(60.58b(d)(2)(xi) references 60.58 b(m).  Certified CEMS option may be used in lieu of stack test.

Note: Approval of CEM options reserved to EPA. See 40 CFR 60.30b and 60.50b(n).

(60.38b Compliance and performance testing  (Continued).

Maryland COMAR <IP_ADDRESS> A(2), B, and C Compliance & Performance Requirements - Region III Review

Pollutant or Parameter

MD

Perf. & Compl. Test Requiremts

Perf. & Compl. Test Requirements

(As Protective(

Comment(s)

 SO2 (ppmv, 24-hr geometric mean % red.)

CEMS

Yes

HCl  (ppmv)

EPA M26

Yes

Certified CEMS option may be used in lieu of stack test.

NOx  (ppmv)

CEMS

Yes

Load (%)

Cont. monitoring of steam load or (alter.method(

Yes

Temperature ( @ part. matter control inlet)

Cont. monitoring

Yes

Fugitive Ash Emissions (VE % of time)

VE Obs.

Yes

((60.39b and 60.59(b) Reporting and recordkeeping guidelines and compliance schedules (COMAR <IP_ADDRESS> C and D):

The COMAR requirements are as protective as 60.39b, as amended.

B. Evaluation of the Maryland Plan revision against the requirements of 40 CFR Part 60, Subpart B, Sections ((60.23 through 60.26

40 CFR 60.23 - Adoption and submittal of State plans and revisions; public hearings.

Federal Requirements

MDE Submittal

(60.23(a)(1) Within nine months after notice of the availability of a final guideline document is

published under (60.22(a), each State shall adopt and submit to the Administrator, in accordance with ( 60.4, a plan for the control of the designated pollutant to which the guideline document applies.

Subpart Cb allows 12 months for plan revision and submittal. Thus, the Plan revision submittal was due May 10, 2007; MDE submitted its revision on October 24, 2007.

(2) Within nine months after notice of the availability of a final revised guideline document is published as provided in (60.22(d)(2), each State shall adopt and submit to the Administrator any plan revision necessary to meet the requirements of this subpart.

As noted above, Subpart Cb allows 12 months for plan submittal. The State's submittal is late.  EPA does not believe this is cause for disapproval.

(60.23(b) If no designated facility is located within a State, the State shall submit a letter of certification to that effect to the Administrator within the time specified in paragraph (a) of this section.  Such certification shall exempt the State from the requirements of this subpart for that designated pollutant.

Not applicable since designated facilities are present.

(60.23(c)(1)  Except as provided in paragraphs (c)(2) and (c)(3) of this section, the State shall, prior to the adoption of any plan or  revision thereof, conduct one or more public hearings within the State on such plan or plan revision.

A public hearings was held on August 8, 2007 in Baltimore, Md.

( 60.23(d) Any hearing required by paragraph (c) of this section shall be held only after reasonable notice. Notice shall be given at

least 30 days prior to the date of such hearing.

Public notice was given on July 6, 2007, more than 30 days prior to the public hearing.

( 60.23(e) The State shall prepare and retain, for a minimum of 2 years, a record of each hearing for inspection by any interested party.  The record shall contain, as a minimum, a list of witnesses together with the text of each presentation.

The State included the records from the public hearing noted above.

( 60.23(f) The State shall submit with the plan or revision:

(1)  Certification that each paragraph (c) of this section was held in accordance with the notice required by paragraph (d) of this section; and                                                                                (2)  A list of witnesses and their organizational affiliations, if any, appearing at the hearing

and a brief written summary of each presentation or written submission.

In its October 24, 2007 letter to EPA and supporting document, the MDE certified the public hearing requirements.

( 60.23(g) provides for alternate procedures to insure public participation.

Not applicable.

40 CFR 60.24  --  Emission standards and compliance schedules

( 60.24(a) Each plan shall include emission standards and compliance schedules.

COMAR <IP_ADDRESS> A(2)

and D contains the required emission standards and compliance schedules.

( 60.24(b)(1) Emission standards shall prescribe allowable rates of emissions except when it is clearly impracticable.  Such cases will be identified in the guideline documents issued under ( 60.22.  Where emission standards prescribing equipment specification are established, the plan shall, to the degree possible, set forth the emission reductions achievable by implementation of such specifications, and may permit compliance by the use of equipment determined by the State to be equivalent to that prescribed.

Not applicable.

    (2) Test methods and procedures for determining compliance with the emission standards shall be specified in the plan.  Methods other than those specified in Appendix A to this part may be specified in the plan if shown to be equivalent or alternative methods are defined in ( 60.2(t) and (u).

COMAR <IP_ADDRESS>.A(2) references the required test methods and procedures specified in the EG and related NSPS. Under COMAR Certified CEMS option may be used in lieu of stack test. Per 60.30b above, CEMS options are subject to EPA review.

    (3) Emission standards shall apply to all designated facilities within the State.  A plan may contain emission standards adopted by local jurisdictions provided that the standards are enforceable by the State.

The emissions standards are applicable to all designated facilities.

( 60.24(c) Except as provided in paragraph (f) of this section where the Administrator has determined that a designated pollutant may cause or contribute to endangerment or public health, emission standards, shall be no less stringent than the corresponding emission guideline(s) specified in Subpart C of this part, and final compliance shall be required as expeditiously as practicable but no later than the compliance times specified in Subpart C of this part.

COMAR <IP_ADDRESS>.A emissions limits are as stringent and protective as required by the EG, as amended, for large MWC units.

( 60.24(d)  Where the Administrator has determined that a designated pollutant may cause or contribute

to endangerment of public welfare but that adverse effects on public health have not been demonstrated, States may balance the emission guidelines, compliance times, and other information provided in the applicable guideline document against other factors of public concern in establishing emission standards, compliance schedules, and variances.  Appropriate consideration shall be given to the factors specified in ( 60.22(b) and to information presented at the public hearing(s) conducted under  ( 60.23(c).

Not applicable.

( 60.24(e)(1)  Any compliance

schedule extending more than 12 months from the date required for submittal of the plan shall include legally enforceable increments of progress to achieve compliance for each designated facility or category of facilities.  Increments of progress shall include, where practicable, each increment of progress specified in ( 60.21(h) and such additional increments of progress as may be necessary to permit close and effective supervision of progress toward final compliance.

60.39b(c)(1)revised this requirement to 1 year beyond the date of EPA plan approval. The required increments of progress are specified at COMAR <IP_ADDRESS>.D.

     (2)  A plan may provide that compliance schedules for individual sources or categories of sources will be formulated after plan submittal.  Any such schedule shall be the subject of a public hearing held accordingly to ( 60.23 and shall be submitted to the Administrator within 60 days after the date of adoption of the schedule but in no case later than the date prescribed for submittal of the first semiannual report required by ( 60.25(e).

Not applicable.

( 60.24(f)  On a case-by-case basis for particular designated facilities, or classes of facilities, States may provide for the application of less stringent emission standards or longer compliance schedule than those otherwise required by paragraph (c)of this section, provided that the State demonstrated with respect to each facility (or class of facilities):

(1)  Unreasonable cost of control resulting from plant age, location or basic process design:

(2)  Physical impossibility of installing necessary control equipment; or

(3)  Other factors specific to the facility (or class of facilities) that make application of a less stringent standard or final compliance time significantly more reasonable.

The State plan is no less stringent than the Federal requirements.

( 60.24(g)  Nothing in this subpart shall be construed to preclude any State or political subdivision thereof from adopting or enforcing

(1)  emission standards more stringent than emission guidelines specified in Subpart C of this part or in applicable guideline  documents or

(2)  compliance schedules requiring final compliance at earlier times than those specified in Subpart C or in applicable guideline documents.

COMAR 26.11.08 contains requirements for small MWC (i.e., unit capacity < 250 TPD) and other types of incinerators that are not subject to the provisions of Subpart Cb; no EPA approval action has been taken on the small MWC and other incinerator requirements. (In the 8/11/05 edition of the FR, EPA notified the public of its 5/25/05 delegation to MDE of the Federal Plan for SMWC units.)

40 CFR 60.25  --  Emission inventories, source surveillance, reports.

( 60.25(a) Each plan shall include an inventory of all designated facilities, including emission data for the designated pollutants and information related to emissions as specified in Appendix D to this part.  Such data shall be  summarized in the plan, and emission rates of designated facilities shall be correlated with applicable emission standards.  As used in this subpart, "correlated" means presented in such a manner as to show the relationship between measured or estimated amounts of emissions and the amounts of such emissions allowable under applicable emission standards.

The Maryland plan includes emission estimates from the two designated facilities. Emission estimates are from continuous emissions monitors and source test data.

( 60.25(b) Each plan shall provide for monitoring the status of compliance with applicable emission standards.  Each plan shall, as a minimum, provide for:

The Maryland MWC regulation references provisions for testing, monitoring, reporting, and recordkeeping. The provisions are the same as those in the EG and NSPS.

	(1)  Legally enforceable procedures for requiring owners and operators of designated facilities to maintain records and periodically report to the State information on the nature and amount of emissions from such facilities, and/or such information as may be necessary to enable the State to determine whether such facilities are in compliance with applicable portions of the plan.

(2)  Periodic inspection and, when applicable, testing of designated facilities.

( 60.25(c) Each plan shall provide that information obtained by the State under paragraph (b) of this section shall be correlated with applicable emission standards (see ( 60.25(a)) and made available to the general public.

MDE may obtain information necessary to determine compliance with its 111(d) plan and make the emissions data available to the public.

( 60.25(d) The provisions referred to in paragraphs (b) and (c) of this section shall be specifically identified.  Copies of such be submitted with the plan unless:

      (1) They have been approved as portions of a preceding plan submitted under this subpart or as portions of an implementation plan  submitted under Section 110 of the Act, and

      (2) The State demonstrates:

(i) That the provisions are applicable to the designated pollutant(s) for which the plan is submitted, and

         (ii) That the requirements of (60.26 are met.

MDE provided a statement that it will comply with all requirements of 60.25; this includes making emissions data available to the public.

(60.25(e) The State shall submit reports on progress in plan enforcement to the Administrator on an annual (calendar year) basis, commencing with the first full report period after approval of a plan or after promulgation of a plan by the Administrator.  Information required under this paragraph must be included in the annual report required by ( 51.321 of this chapter.

The MDE will submit to EPA on an annual basis a report which details the progress in enforcement of the 111(d) plan in accordance with 40 CFR 60.25. The first progress report will be submitted to EPA one year after the approval of the State plan.

( 60.25(f)  Each progress report shall include:

(1) Enforcement actions initiated against designated facilities during the reporting period, under any emission standard or compliance schedule of the plan.

(2) Identification of the achievement of any increment of progress required by the applicable plan during the reporting period.

(3) Identification of designated facilities that have ceased operation during the report period.

    (4) Submission of emission inventory data as described in paragraph (a) of this section for designated facilities that were not in operation at the time of plan development but began operation during the reporting period.

Same as above.

(5) Submission of additional data as necessary to update the information submitted under paragraph (a) of this section or in previous progress reports.

     (6) Submission of copies of technical reports on all performance testing on designated facilities conducted under paragraph (b)(2) of this section, complete with concurrently recorded process data.

( 60.26  --  Legal authority

( 60.26(a)  Each plan shall show that the State has legal authority to carry out the plan, including authority to:

(1)  Adopt emission standards and compliance schedules applicable to designated facilities.

(2)  Enforce applicable laws, regulations, standards, and compliance schedules, and seek injunction relief.

(3)  Obtain information necessary to determine whether designated facilities are in compliance with applicable laws, regulations, standards, and compliance schedules, including authority to require recordkeeping and to make inspections and conduct tests of designated facilities.

(4)  Require owners or operators of designated facilities to install, maintain, and use emission monitoring devices and to make periodic reports to the State on the nature and amounts of emissions from such facilities; also authority for the State to make such data available to the public as reported and as correlated with applicable emission standards.

Maryland(s legal authority is derived from Title 2 of the Environment Article, Annotated Code of Maryland, Sections 2-103(b) and 2-301. Legal authority for operator requirements is derived from section 2-406.

( 60.26(b) The provisions of law or regulations which the State determines, provide the authorities required by this section shall be specifically identified.  Copies of such laws or regulations shall be submitted with the plan unless:

(1)  They have been approved as portions of a preceding plan submitted under this subpart or as portions of an implementation plan submitted under Section 110 of the Act, and

     (2)  The State demonstrates that the laws or regulations are applicable to the designated pollutant(s) for which the plan is submitted.

Same as above. EPA has approved previous Maryland 111(d) plans - sulfuric acid plants, kraft pulp mills,  primary aluminum reduction plants, large MWC, and HMIWI units.

( 60.26(c) The plan shall show that the legal authorities specified in this section are available to the State at the time of submission of the plan.  Legal authority adequate to meet the requirements of paragraphs (a)(3) and (4) of this section may be delegated to the State under Section 114 of the Act.

Same as above. Legal authority cited in submitted plan.

( 60.26(d) A State governmental agency other than the State air pollution control agency may be assigned responsibility for carrying out a portion of a plan if the plan demonstrates to the Administrator's satisfaction that the State governmental agency has the legal authority necessary to carry out that portion of the plan.

Not applicable.

( 60.26(e) The State may authorize a local agency to carry out a plan or portion thereof, within the local agency's jurisdiction if the plan demonstrates to the Administrator's satisfaction that the local agency has the legal authority necessary to implement the plan or portion thereof, and that the authorization does not relieve the State of responsibility under the Act for carrying out the plan or portion thereof.

Not applicable.

V.  CONCLUSION

The Maryland 111(d)/129 plan revision for large MWC units and the applicable portions of COMAR 26.11.08, as amended on September 28, 2007, are approvable. The COMAR amendments meet the requirements of 40 CFR Part 60, subpart Cb, as published in the Federal Register on May 10, 2006. Consistent with EPA policy and subpart Cb, the scope and delegation of certain authorities is retained by EPA as stipulated in 60.30b and the related subpart Eb NSPS provisions of 60.50b(n).

 PAGE  1


[Federal Register Volume 84, Number 143 (Thursday, July 25, 2019)]
[Rules and Regulations]
[Pages 35833-35836]
[FR Doc No: 2019-15765]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2019-0003; Internal Agency Docket No. FEMA-8589]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date. Also, information identifying
the current participation status of a community can be obtained from
FEMA's Community Status Book (CSB). The CSB is available at https://www.fema.gov/national-flood-insurance-program-community-status-book.

DATES: The effective date of each community's scheduled suspension is
the third date (``Susp.'') listed in the third column of the following
tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact Adrienne L. Sheldon, PE, CFM, Federal
Insurance and Mitigation Administration, Federal Emergency Management
Agency, 400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase

Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of
legally enforceable floodplain management measures after this rule is
published but prior to the actual suspension date. These communities
will not be suspended and will continue to be eligible for the sale of
NFIP flood insurance. A notification withdrawing the suspension of such
communities will be published in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and public comment procedures under 5
U.S.C. 553(b), are impracticable and unnecessary because communities
listed in this final rule have been adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. FEMA has determined that the
community suspension(s) included in this rule is a non-discretionary
action and therefore the National Environmental Policy Act of 1969 (42
U.S.C. 4321 et seq.) does not apply.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended,
Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless
an appropriate public body adopts adequate floodplain management
measures with effective enforcement measures. The communities listed no
longer comply with the statutory requirements, and after the effective
date, flood insurance will no longer be available in the communities
unless remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for part 64 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6   [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                Effective date
                                                authorization/
                                  Community    cancellation  of    Current effective map   Date certain  Federal
      State and location             No.         sale of flood             date            assistance no longer
                                                 insurance in                               available in  SFHAs
                                                   community
----------------------------------------------------------------------------------------------------------------
           Region V

Illinois:
    Addison, Village of,              170198  July 23, 1973,      Aug. 1, 2019..........  Aug. 1, 2019.
     DuPage County.                            Emerg; March 15,
                                               1979, Reg; August
                                               1, 2019, Susp.
    Bartlett, Village of,             170059  October 15, 1974,   ......do..............   Do.
     Cook, DuPage and Kane                     Emerg; June 15,
     Counties.                                 1981, Reg; August
                                               1, 2019, Susp.
    Bensenville, Village of,          170200  May 22, 1974,       ......do..............   Do.
     Cook and DuPage Counties.                 Emerg; February
                                               4, 1981, Reg;
                                               August 1, 2019,
                                               Susp.
    Bloomingdale, Village of,         170201  June 6, 1974,       ......do..............   Do.
     DuPage County.                            Emerg; April 15,
                                               1981, Reg; August
                                               1, 2019, Susp.
    Carol Stream, Village of,         170202  September 4, 1973,  ......do..............   Do.
     DuPage County.                            Emerg; January 6,
                                               1982, Reg; August
                                               1, 2019, Susp.
    Chicago, City of, Cook and        170074  August 23, 1974,    ......do..............   Do.
     DuPage Counties.                          Emerg; June 1,
                                               1981, Reg; August
                                               1, 2019, Susp.
    Darien, City of, DuPage           170750  September 6, 1974,  ......do..............   Do.
     County.                                   Emerg; February
                                               1, 1980, Reg;
                                               August 1, 2019,
                                               Susp.
    Elk Grove Village, Village        170088  November 3, 1972,   ......do..............   Do.
     of, Cook and DuPage                       Emerg; June 15,
     Counties.                                 1979, Reg; August
                                               1, 2019, Susp.
    Hanover Park, Village of,         170099  April 19, 1973,     ......do..............   Do.
     Cook and DuPage Counties.                 Emerg; November
                                               15, 1978, Reg;
                                               August 1, 2019,
                                               Susp.
    Hinsdale, Village of, Cook        170105  April 22, 1975,     ......do..............   Do.
     and DuPage Counties.                      Emerg; January
                                               16, 1981, Reg;
                                               August 1, 2019,
                                               Susp.
    Itasca, Village of, DuPage        170210  May 29, 1973,       ......do..............   Do.
     County.                                   Emerg; November
                                               2, 1977, Reg;
                                               August 1, 2019,
                                               Susp.
    Lisle, Village of, DuPage         170211  July 6, 1973,       ......do..............   Do.
     County.                                   Emerg; September
                                               17, 1980, Reg;
                                               August 1, 2019,
                                               Susp.
    Lombard, Village of,              170212  December 29, 1972,  ......do..............   Do.
     DuPage County.                            Emerg; October
                                               17, 1978, Reg;
                                               August 1, 2019,
                                               Susp.
    Oak Brook, Village of,            170214  January 13, 1975,   ......do..............   Do.
     Cook and DuPage Counties.                 Emerg; February
                                               18, 1981, Reg;
                                               August 1, 2019,
                                               Susp.
    Oakbrook Terrace, City of,        170215  April 15, 1975,     ......do..............   Do.
     DuPage County.                            Emerg; February
                                               18, 1981, Reg;
                                               August 1, 2019,
                                               Susp.
    Roselle, Village of, Cook         170216  March 2, 1973,      ......do..............   Do.
     and DuPage Counties.                      Emerg; May 19,
                                               1981, Reg; August
                                               1, 2019, Susp.
    Schaumburg, Village of,           170158  October 13, 1972,   ......do..............   Do.
     Cook and DuPage Counties.                 Emerg; February
                                               15, 1979, Reg;
                                               August 1, 2019,
                                               Susp.
    Villa Park, Village of,           170217  April 23, 1974,     ......do..............   Do.
     DuPage County.                            Emerg; February
                                               4, 1981, Reg;
                                               August 1, 2019,
                                               Susp.
    Wood Dale, City of, DuPage        170224  February 2, 1973,   ......do..............   Do.
     County.                                   Emerg; September
                                               30, 1977, Reg;
                                               August 1, 2019,
                                               Susp.

          Region VII

Nebraska:
    Aurora, City of, Hamilton         310105  December 23, 1974,  ......do..............   Do.
     County.                                   Emerg; August 16,
                                               1988, Reg; August
                                               1, 2019, Susp.
    Hamilton County,                  310441  N/A, Emerg; June    ......do..............   Do.
     Unincorporated Areas.                     21, 1993, Reg;
                                               August 1, 2019,
                                               Susp.
    Henderson, City of, York          310378  July 7, 1975,       ......do..............   Do.
     County.                                   Emerg; September
                                               4, 1986, Reg;
                                               August 1, 2019,
                                               Susp.
    McCool Junction, Village          310236  June 4, 1975,       ......do..............   Do.
     of, York County.                          Emerg; September
                                               4, 1987, Reg;
                                               August 1, 2019,
                                               Susp.
    Waco, Village of, York            310331  March 16, 2011,     ......do..............   Do.
     County.                                   Emerg; August 31,
                                               2011, Reg; August
                                               1, 2019, Susp.
    York County,                      310486  April 16, 1980,     ......do..............   Do.
     Unincorporated Areas.                     Emerg; September
                                               1, 1986, Reg;
                                               August 1, 2019,
                                               Susp.

           Region X

Alaska: Sitka, City and               020006  November 8, 1974,   ......do..............   Do.
 Borough of.                                   Emerg; June 1,
                                               1982, Reg; August
                                               1, 2019, Susp.
----------------------------------------------------------------------------------------------------------------
 ......do, Do. = Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

    Dated: July 15, 2019.
Katherine B. Fox,
Assistant Administrator for Mitigation, Federal Insurance and
Mitigation Administration--FEMA Resilience, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2019-15765 Filed 7-24-19; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register Volume 77, Number 246 (Friday, December 21, 2012)]
[Rules and Regulations]
[Pages 75557-75559]
[FR Doc No: 2012-30752]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2012-1041]
RIN 1625-AA00

Safety Zones; New Year's Eve Fireworks Displays Within the
Captain of the Port Miami Zone, FL

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing three temporary safety zones
during New Year's Eve fireworks displays on certain navigable waterways
in Biscayne Bay and Palm Beach, Florida. These safety zones are
necessary to protect the public from the hazards associated with
launching fireworks over navigable waters of the United States. Persons
and vessels are prohibited from entering, transiting through, anchoring
in, or remaining within any of the three safety zones unless authorized
by the Captain of the Port Miami or a designated representative.

DATES: This rule is effective from 10:00 p.m. December 31, 2012 until
12:30 a.m. January 1, 2013.

ADDRESSES: Documents mentioned in this preamble are part of docket
USCG-2012-1041. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Junior Grade Mike H. Wu, Sector Miami
Prevention Department, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the Coast Guard did not receive all
Marine Event Permit Application information regarding the fireworks
displays until November 16, 2012. As a result, the Coast Guard did not
have sufficient time to publish an NPRM and to receive public comments
prior to the fireworks displays. Any delay in the effective date of
this rule would be contrary to the public interest because immediate
action is needed to minimize potential danger to the public during the
fireworks displays.
    For the same reason discussed above, under 5 U.S.C. 553(d)(3) the
Coast Guard finds that good cause exists for making this rule effective
less than 30 days after publication in the Federal Register.

B. Basis and Purpose

    The legal basis for the rule is the Coast Guard's authority to
establish regulated navigation areas and other limited access areas: 33
U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33
CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-295, 116 Stat. 2064;
Department of Homeland Security Delegation No. 0170.1.
    The purpose of the rule is to protect the public from the hazards
associated with the launching of fireworks over navigable waters of the
United States.

C. Discussion of Rule

    Multiple fireworks displays are planned for New Year's Eve
celebrations throughout the Captain of the Port Miami Zone. The
fireworks will be launched from barges and will explode over navigable
waters of the United States.
    The Coast Guard is establishing three temporary safety zones for
New Year's Eve fireworks displays on Monday, December 31, 2012 on
navigable waters of the Captain of the Port Miami Zone. The three
safety zones are listed below.

    1. Miami, Florida. All waters within a 280 yard radius around the
barge from which the fireworks will be launched, located 200 yards east
of Bay Front Park. This safety zone will be enforced from 10:00 p.m. on
December 31, 2012 until 12:30 a.m. on January 1, 2013.
    2. Miami Beach, Florida. All waters within a 280 yard radius around
the barge from which the fireworks will be launched, located 650 yards
northeast of Star Island, and west of the Mondrian Hotel in Miami
Beach, FL. This safety zone will be enforced from 10:00 p.m. on
December 31, 2012 until 12:30 a.m. on January 1, 2013.
    3. West Palm Beach, Florida. All waters within a 280 yard radius
around the barge from which the fireworks will be launched, located 650
yards north of Royal Park Bascule Bridge. This safety zone will be
enforced from 10:00 p.m. on December 31, 2012 until 12:30 a.m. on
January 1, 2013.
    Persons and vessels are prohibited from entering, transiting
through, anchoring in, or remaining within any of the safety zones
unless authorized by the Captain of the Port Miami or a designated
representative. Persons and vessels desiring to enter, transit through,
anchor in, or remain within any of the safety zones may contact the
Captain of the Port Miami by telephone at<PHONE_NUMBER>, or a designated
representative via VHF radio on channel 16, to request authorization.
If authorization to enter, transit through, anchor in, or remain within
any of the safety zones is granted by the Captain of the Port Miami or
a designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port Miami or a designated representative. The Coast Guard will provide
notice of the safety zones by Local Notice to Mariners, Broadcast
Notice to Mariners, and on-scene designated representatives.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. The economic impact of
this rule is not significant for the following reasons: (1) The safety
zones will be enforced for a maximum of 2 and a half hours each; (2)
non-participant persons and vessels may enter, transit through, anchor
in, or remain within the safety zones if authorized by the Captain of
the Port Miami or a designated representative; (3) non-participant
persons and vessels not authorized by the Captain of the Port Miami or
designated representative to enter, transit through, anchor in, or
remain within the safety zones may operate in the surrounding area
during the enforcement periods; and (4) the Coast Guard will provide
advance notification of the safety zones to the local maritime
community by Local Notice to Mariners and Broadcast Notice to Mariners.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities. This rule may affect the following entities, some of
which may be small entities: The owners or operators of vessels
intending to enter, transit through, anchor in, or remain within the
three safety zones established by this regulation during the respective
enforcement period.
    For the reasons discussed in the Regulatory Planning and Review
section above, this rule will not have a significant economic impact on
a substantial number of small entities.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and

Interference with Constitutionally Protected Property Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not 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.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves the creation of three temporary safety
zones that will be enforced for a total of 31 minutes. This rule is
categorically excluded, under figure 2-1, paragraph (34)(g), of the
Instruction. An environmental analysis checklist supporting this
determination and a Categorical Exclusion Determination is available in
the docket where indicated under ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-
295, 116 Stat. 2064; Department of Homeland Security Delegation No.
0170.1.

0
2. Add a temporary Sec.  165.T07-1041 to read as follows:

Sec.  165.T07-1041  Safety Zones; New Year's Eve Fireworks Displays
within the Captain of the Port Miami Zone, FL.

    (a) Regulated Areas. The following regulated areas are safety
zones:
    (1) Miami, FL. All waters within a 280 yard radius around the barge
from which the fireworks will be launched, located on Biscayne Bay in
approximate position 25[deg]46'32'' N, 80[deg]10'56'' W. This regulated
area will be enforced from 10:00 p.m. on December 31, 2012 until 12:30
a.m. on January 1, 2013.
    (2) Miami Beach, FL. All waters within a 280 yard radius around the
barge from which the fireworks will be launched, located on Biscayne
Bay in approximate position 25[deg]46'55'' N, 80[deg]08'41'' W. This
regulated area will be enforced from 10:00 p.m. on December 31, 2012
until 12:30 a.m. on January 1, 2013.
    (3) Palm Beach, FL. All waters within a 280 yard radius around the
barge from which the fireworks will be launched, located on
Intracoastal Waterway in approximate position 26[deg]42'32'' N,
80[deg]02'48'' W. This regulated area will be enforced from 10:00 p.m.
on December 31, 2012 until 12:30 a.m. on January 1, 2013.
    (b) Palm Beach, FL. All waters within a 280 yard radius around the
barge from which the fireworks will be launched, located in the
Intracoastal Waterway in approximate position 26[deg]42'32'' N,
80[deg]02'48'' W. This regulated area will be enforced from 10:00 p.m.
on December 31, 2012 until 12:30 a.m. on January 1, 2013.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the
Captain of the Port Miami in the enforcement of the regulated areas.
    (c) Regulations. (1) All persons and vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
regulated areas unless authorized by the Captain of the Port Miami or a
designated representative.
    (2) Persons and vessels desiring to enter, transit through, anchor
in, or remain within the regulated areas may contact the Captain of the
Port Miami by telephone at<PHONE_NUMBER>, or a designated representative
via VHF radio on channel 16, to request authorization. If authorization
to enter, transit through, anchor in, or remain within the regulated
areas is granted by the Captain of the Port Miami or a designated
representative, all persons and vessels receiving such authorization
must comply with the instructions of the Captain of the Port Miami or a
designated representative.
    (3) The Coast Guard will provide notice of the regulated areas by
Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene
designated representatives.
    (d) Effective Date. This rule is effective from 10:00 p.m. on
December 31, 2012 until 12:30 a.m. on January 1, 2013.

    Dated: December 7, 2012.
C.P. Scraba,
Captain, U.S. Coast Guard, Captain of the Port Miami.
[FR Doc. 2012-30752 Filed 12-20-12; 8:45 am]
BILLING CODE 9110-04-P


For Utilities, Communities, and Organizations

Using the WaterSense Brand/Logo

Promotional Partner Checklist

Please complete and submit with a signed WaterSense promotional
partnership agreement.

Section I: Marketing Contact Information

Organization Name:
____________________________________________________________

Main Promotional or Marketing Contact (for questions regarding this
plan)

Name:
________________________________Telephone:______________________________

Fax:	________________________________E-mail:
_________________________________

Number of residential customers in service area:
______________________________________

Section II: WaterSense Branding and Logo Use

As we build a national brand for water efficiency, WaterSense invites
its promotional partners to use the WaterSense logo, messages, and
materials in outreach and educational activities promoting
water-efficient products and practices, consistent with the WaterSense
guidelines. In which of the following areas do you plan to use the
WaterSense logo and/or label for promotional purposes?

□	Consumer education and outreach

□	Community events and/or retail promotions

□	Web site

□	Rebate program that refers to the WaterSense label (please describe
below)

□	Bill stuffers, brochures, or other constituent communications

□	Advertising/PSAs (please specify which and where they will be
placed)

□	Turnkey outreach campaign with WaterSense brand (please describe
below)

□	Schools, institutions, or commercial outreach

□	Other (please describe in detail below)

________________________________________________________________________
____________

________________________________________________________________________
____________

________________________________________________________________________
____________

________________________________________________________________________
____________

Section III: Promotional Efforts and Plans

WaterSense would like to know more about your current and planned water
efficiency outreach efforts to assess how we can best serve our
partners. Please include activities such as education campaigns,
rebates, performance contracting, irrigation audits, or other programs
that focus on specific indoor or outdoor water use.

1) What activities or incentive programs do you currently conduct to
educate consumers/businesses about water efficiency? (If you have Web
page for your water efficiency program, please provide the URL.)

________________________________________________________________________
____________

________________________________________________________________________
____________

________________________________________________________________________
____________

________________________________________________________________________
____________

2) What new activities or incentive programs will you consider
conducting to educate consumers, organizations, or businesses about
WaterSense?

________________________________________________________________________
____________

________________________________________________________________________
____________

________________________________________________________________________
____________

________________________________________________________________________
____________

3) As the program evolves,
Water敓獮楷汬挠湯楴畮潴挠敲瑡潴汯⁳湡慭整
楲污⁳潦⁲慰瑲敮獲敗愠敲椠瑮牥獥整湩礠畯⁲敦
摥慢正※汰慥敳氠瑥甠⁳湫睯栠睯眠慣獡楳瑳礠畯
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湥敳瀠潲畤瑣⁳湡牰杯慲獭മ

□	Template promotional tools, such as:
___________________________________

□	Assistance in technical areas (e.g., performance contracting)

□	Case studies of successful promotional efforts

□	Partnerships with government, retail, or nonprofit programs

□	Other: ___________________________________________________________

For questions regarding this form, please call (866) WTR-SENSE / (866)
987-7367 or e-mail <  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>>. Upon completion, please fax this form to
WaterSense at<PHONE_NUMBER>.

 Please use the same organization name used on your partnership
agreement. If you do not yet have a partnership agreement, please
contact us to complete one.

 For utilities only

Æ

-

2

4

Ì

Î

2

Ì

ᄀ 2040-XXXX

Approval Expires XX/XX/XXXX

 PAGE

 PAGE   1

EPA Form Number 6100-10

The public reporting and recordkeeping burden for this collection of
information is estimated to average 13 hours per response. Send comments
on the Agency's need for this information, the accuracy of the provided
burden estimates, and any suggested methods for minimizing respondent
burden, including through the use of automated collection techniques to
the Director, Collection Strategies Division, U.S. Environmental
Protection Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C.
20460. Include the OMB control number in any correspondence. Do not send
the completed promotional plan checklist to this address.


[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)]
[Notices]
[Pages 40395-40396]
[FR Doc No: 2016-14554]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2012-0033]

Notice of Intent To Grant a Buy America Waiver to the City of
Sacramento, California, Department of Public Works, To Use Marmoleum
Flooring

AGENCY: Federal Railroad Administration (FRA), United States Department
of Transportation (DOT).

ACTION: Notice of intent to grant Buy America waiver.

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SUMMARY: FRA is issuing this notice to advise the public it intends to
grant the City of Sacramento, California, Department of Public Works
(Sacramento), a waiver from FRA's Buy America requirement to use Walton
Cirrus Original Brown #3665 (Brown Marmoleum), in the Sacramento Valley
Station Phase II intermodal project.

DATES: Written comments on FRA's determination to grant Sacramento's
Buy America waiver request should be provided to the FRA on or before
June 28, 2016.

ADDRESSES: Please submit your comments by one of the following means,
identifying your submissions by docket number FRA-2012-0033. All
electronic submissions must be made to the U.S. Government electronic
site at http://www.regulations.gov. Commenters should follow the
instructions below for mailed and hand-delivered comments:
    (1) Web site: http://www.regulations.gov. Follow the instructions
for submitting comments on the U.S. Government electronic docket site;
    (2) Fax:<PHONE_NUMBER>;

    (3) Mail: U.S. Department of Transportation, 1200 New Jersey Avenue
SE., Docket Operations, M-30, Room W12-140, Washington, DC 20590-0001;
or
    (4) Hand Delivery: Room W12-140 on the first floor of the West
Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Instructions: All submissions must reference the ``Federal Railroad
Administration'' and include docket number FRA-2012-0033. Due to
security procedures in effect since October 2001, mail received through
the U.S. Postal Service may be subject to delays. Parties submitting
responses to this notice should consider using an express mail firm to
ensure the prompt filing of any submissions not filed electronically or
by hand. Note that all submissions received, including any personal
information therein, will be posted without change or alteration to
http://www.regulations.gov. For more information, you may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477), or visit http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Mr. John Johnson, Attorney-Advisor,
FRA Office of Chief Counsel, 1200 New Jersey Avenue SE., Mail Stop 10,
Washington, DC 20590,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    FRA provides information on its reasons for granting this waiver in
a letter to Sacramento, quoted below:
Mr. Gregory Taylor
AIA, Supervising Architect/Project Manager
City of Sacramento, Department of Public Works
915 I Street
Room 2000
Sacramento, CA 95814-2604

Re: Request for Waiver of Buy America Requirement

Dear Mr. Taylor:

    As you are aware, on November 24, 2014, the City of Sacramento,
California, Department of Public Works (Sacramento) requested a waiver
from the Federal Railroad Administration's (FRA) Buy America
requirement (49 U.S.C. 24405(a)) to purchase ``Marmoleum,''
specifically the color Walton Cirrus Original Brown #3665 (Brown
Marmoleum), a natural linoleum flooring product made by Forbo Flooring
Systems in the Netherlands, for use in the Sacramento Valley Station
(SVS) Phase II intermodal project.\1\ The Brown Marmoleum will cover
1,480 sq. ft and costs approximately $4,690.
---------------------------------------------------------------------------

    \1\ Sacramento also requested a waiver for Sacramento requested
a non-availability Buy America waiver for a variable refrigerant
flow (VRF) heating, ventilation, and air conditioning (HVAC) system
to be installed into SVS. However, FRA chose to bifurcate the waiver
requests since the VRF waiver was more advanced in terms of
processing and was pivotal to Sacramento. FRA granted a waiver for
the VRF system on June 4, 2015. https://www.fra.dot.gov/eLib/Details/L16619.
---------------------------------------------------------------------------

    The SVS Phase II intermodal project is the rehabilitation of the
historic 68,000 square foot train station in downtown Sacramento,
California. The $30 million project is partially funded with a $15
million 2012 Transportation Infrastructure Generating Economic Recovery
(TIGER) grant. The U.S. Department of Transportation (DOT) selected
each project for 2012 TIGER Grant funding based on whether it would,
among other things, promote a more environmentally sustainable
transportation system. 77 FR 4863, 4867 (January 31, 2012). After
rehabilitation, the SVS will include an Amtrak station, commercial
retail and office space.
    To support its waiver request, Sacramento contends that Brown
Marmoleum natural linoleum is the only flooring that meets the
standards in the Secretary of Interior's Standards for the Treatment of
Historic Properties with Guidelines for Preserving, Rehabilitating, and
Reconstructing Historic Buildings. Specifically, Sacramento asserts
that Brown Marmoleum is the only flooring product that sufficiently
matches the design, color, and texture of the original historic
flooring used in SVS. Forbo does not manufacture Brown Marmoleum in the
United States. After comparing flooring samples to the original
flooring, California's State Historic Preservation Office and FRA
determined Brown Marmoleum is the only product best matching the
original linoleum's design, color, and texture.
    Therefore, FRA is granting Sacramento's waiver request. FRA
concludes a waiver is appropriate under 49 U.S.C. 24405(a)(2)(B) for
Brown Marmoleum because domestically-produced flooring meeting the
specific needs of Sacramento for this application (i.e., historic
preservation) is not currently ``produced in sufficient and reasonably
available amount or . . . [is] not of a satisfactory quality.'' 49
U.S.C. 24405(a)(2)(B).
    Pursuant to 49 U.S.C. 24405(a)(4), FRA will publish this letter
granting Sacramento's request in the Federal Register and provide
notice of such finding and an opportunity for public comment after
which this waiver will become effective.
    Questions about this letter can be directed to, John Johnson,
Attorney-Advisor, at<EMAIL_ADDRESS>or<PHONE_NUMBER>.

    Sincerely,

    Sarah E. Feinberg
    Administrator

    Issued in Washington, DC, on June 15, 2016.
Amitabha Bose,
Chief Counsel.
[FR Doc. 2016-14554 Filed 6-20-16; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Notices]
[Page 56865]
[FR Doc No: 2018-24736]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3406-EM; Docket ID FEMA-2018-0001]

Georgia; Amendment No. 1 to Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of an emergency declaration for
the State of Georgia (FEMA-3406-EM), dated October 10, 2018, and
related determinations.

DATES: This amendment was issued November 2, 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 the incident
period for this emergency is closed effective October 23, 2018.

    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. 2018-24736 Filed 11-13-18; 8:45 am]
 BILLING CODE 9111-11-P


[Federal Register Volume 86, Number 12 (Thursday, January 21, 2021)]
[Notices]
[Page 6320]
[FR Doc No: 2021-01241]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OARM-2017-0752; FRL-10019-37-OMS]

Proposed Information Collection Request; Comment Request;
Background Checks for Contractor Employees (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``Background Checks for
Contractor Employees (Renewal)'' (EPA ICR No. 2159.08, OMB Control No.
2030-0043) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act. Before doing
so, EPA is soliciting public comments on specific aspects of the
proposed information collection as described below. This is a proposed
extension of the ICR, which is currently approved through September 30,
2021. An Agency may not conduct or sponsor and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number.

DATES: Comments must be submitted on or before March 22, 2021.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OARM-
2017-0752 online using www.regulations.gov (our preferred method), by
email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Denise Clarke, Policy Training and
Oversight Division, Office of Acquisition Solutions (3802R),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: The EPA uses contractors to perform services throughout
the nation with regard to environmental emergencies involving the
release, or threatened release, of oil, radioactive materials, or
hazardous chemicals that may potentially affect communities and the
surrounding environment. The Agency may request contractors responding
to any of these types of incidents to conduct background checks and
apply Government-established suitability criteria in Title 5 CFR
Administrative Personnel 731.104 Appointments Subject to Investigation,
732.201 Sensitivity Level Designations and Investigative Requirements,
and 736.102 Notice to Investigative Sources when determining whether
employees are acceptable to perform on given sites or on specific
projects. In addition to emergency response contractors, EPA may
require background checks for contractor personnel working in sensitive
sites or sensitive projects. The background checks and application of
the Government's suitability criteria must be completed prior to
contract employee performance. The contractor shall maintain records
associated with all background checks. Background checks cover
citizenship or valid visa status, criminal convictions, weapons
offenses, felony convictions, and parties prohibited from receiving
federal contracts.
    Form Numbers: None.
    Respondents/affected entities: Private Contractors.
    Respondent's obligation to respond: Required to obtain a benefit
per Title 5 CFR Administrative Personnel 731.104 Appointments Subject
to Investigation, 732.201 Sensitivity Level Designations and
Investigative Requirements, and 736.102 Notice to Investigative
Sources.
    Estimated number of respondents: 1,000 (total).
    Frequency of response: Annual.
    Total estimated burden: 1,000 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $208,720 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in Estimates: There is no change in the hours in the total
estimated respondent burden compared with the ICR currently approved by
OMB.

Kimberly Patrick,
Director, Office of Acquisition Solutions.
[FR Doc. 2021-01241 Filed 1-19-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: January 21, 2009 (Volume 74, Number 12)]
[Notices]
[Page 3614-3615]
[DOCID:fr21ja09-87]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0224]

Final Guidance for Sponsors, Industry, Researchers,
Investigators, and Food and Drug Administration Staff: Certifications
To Accompany Drug, Biological Product, and Device Applications/
Submissions: Compliance with Section 402(j) of The Public Health
Service Act, Added By Title VIII of The Food and Drug Administration
Amendments Act of 2007; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or agency) is announcing
the availability of a guidance for industry entitled ``Guidance for
Sponsors, Industry, Researchers, Investigators, and Food and Drug
Administration Staff: Certifications To Accompany Drug, Biological
Product, and Device Applications/Submissions: Compliance with Section
402(j) of The Public Health Service Act, Added By Title VIII of The
Food and Drug Administration Amendments Act of 2007'' dated January
2009. The guidance provides sponsors, industry, researchers,
investigators, and FDA staff with the agency's current thinking
regarding the types of applications and submissions that sponsors,
industry, researchers, and investigators submit to FDA and accompanying
certifications as described in Title VIII of the Food and Drug
Administration Amendments Act of 2007 (FDAAA).

DATES: Submit written or electronic comments on agency guidances at any
time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Policy, Office of Commissioner, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, rm. 4305, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>. Send one self addressed adhesive
label to assist that office in processing your requests. Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm.1061, Rockville, MD 20852. Submit
electronic comments to http://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.

FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy,
Office of Commissioner, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 1, rm. 4305, Silver Spring, MD 20993-0002, 301-
796-4830.

SUPPLEMENTARY INFORMATION:

I. Background

    Title VIII of FDAAA, Public Law 110-85, amended the Public Health
Service (PHS) Act by adding new section 402(j), 42 U.S.C. 282(j). The
new provisions require that additional information be submitted to the
clinical trials data bank (www.ClinicalTrials.gov) previously
established by the National Institutes of Health (NIH)/National Library
of Medicine (NLM), including expanded information on clinical trials
and information regarding the results of clinical trials.
    The purpose of Title VIII is to provide a means for ensuring that
the public has access to information about certain clinical trials.
Specifically, Title VIII is intended to provide a mechanism for the
public to learn about clinical trials that are being conducted, as well
as the results of those trials. One provision of Title VIII (section
401(j)(5)(B) of the PHS Act, 42 U.S.C. 282(j)(5)(B)) requires that a
certification accompany certain human drug, biological product, and
device applications and submissions to FDA.
    The certification required under section 402(j)(5)(B) of the PHS
Act (42 U.S.C. 282(j)(5)(B)) plays a role in helping to achieve the
purposes of Title VIII of FDAAA. One purpose of the certification is to
require the submitter to confirm that it has complied with all
applicable requirements of Title VIII, including the requirement to
register applicable clinical trials. ``Applicable clinical trial'' is
defined at section 402(j)(1)(A)(i) of the PHS Act (42 U.S.C.
282(j)(1)(A)(i)). For additional information on this definition and
other relevant definitions, visit the NIH Web site at http://
prsinfo.clinicaltrials.gov.
    Failure to submit a certification, knowingly submitting a false
certification, failure to submit required clinical trial information,
and submission of clinical trial information that is false or
misleading are all, as added by Title VIII of FDAAA, prohibited acts
under section 301(jj) of the Federal Food, Drug, and Cosmetic Act (the
act). Requiring a certification to accompany certain applications and
submissions submitted to FDA is, therefore, one way of encouraging
compliance with the provisions of the law.
    The certification also facilitates FDA's exercise of its
responsibilities under the law. The certification requirement is
critical to the agency's ability to determine whether the law has been
complied with and whether an enforcement action is appropriate under
any of the prohibited acts under section 301(jj) of the act.
Additionally, section 402(j)(3)(F) of the PHS Act (42 U.S.C.
282(j)(3)(F)) requires FDA to notify the Director of NIH of certain
actions taken on applications and reports that were accompanied by a
certification. That notification alerts NIH to the fact that the
responsible party must submit the results of the trials within a
certain period of time, thereby enabling NIH to exercise its
responsibilities under Title VIII. The information provided in the
certification form also will help FDA assist NIH in ``linking''
information posted on FDA's Web site regarding certain FDA regulatory
actions to specific applicable clinical trials included in the registry
and results databases. This linking, using the information in the
certification form, particularly the NCT (National Clinical Trial)
number(s) required in the form, eventually will allow FDA to help the
public more easily correlate various reports, medical reviews,
advisories, health alerts, advisory committee actions, and other
materials with specific applicable clinical trials registered with
ClinicalTrials.gov and identified by the NCT number.
    The certification requirement went into effect on December 26,
2007. To assist sponsors, industry, researchers, and investigators in
complying with the requirement, FDA created a certification form, FDA
Form 3674, OMB Control No. 0910-0616, to be used to satisfy the
certification requirement. Since the provision went into effect, FDA
has received numerous inquiries asking whether various kinds of
information and documents that sponsors, industry, researchers, and
investigators submit to

the agency must be accompanied by the certification. On April 18, 2008,
FDA published a draft guidance on the certification requirement. In the
draft guidance FDA provided a list of the types of submissions and
applications that typically did not need to be accompanied by a
certification. We received a number of comments to the docket
concerning whether a certification should accompany the types of
submissions and applications listed in the draft guidance, as well as
other types of documents and information submitted to FDA. We also
received a number of comments on this issue during the process for
obtaining clearance under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520) for the certification form itself. In addition, FDA
also has had more experience with the submission of the certification
form since the form was implemented.
    The comments we received in response to the draft guidance and the
development of the certification form, the inquiries to the agency, and
our evolving experience caused us to reconsider our initial approach of
identifying those documents and information that did not need to be
accompanied by a certification. Instead, we concluded that it was more
useful to identify those applications and submissions that must be
accompanied by a certification. This approach is also consistent with
many of the comments, which asked that we provide more specific
information than was included in the draft guidance. Thus, we intend to
exercise enforcement discretion concerning the submission of a
certification with certain categories of applications and submissions
to FDA, as noted in the guidance.
    This guidance describes FDA's current thinking, for purposes of
implementing Title VIII of FDAAA, regarding specific types of
applications and submissions submitted to FDA under section 505, 515,
520(m), or 510(k) of the act, or under section 351 of the PHS Act, and
accompanying certifications described in section 402(j)(5)(B) of the
PHS Act, 42 U.S.C. 282(j)(5)(B). We note that the Agency's discussion
of ``applications'' and ``submissions'' in this guidance is not
necessarily applicable to any other provision of law. In determining
how to interpret the certification requirement, FDA has focused on the
plain language of Title VIII of FDAAA, as well as information that
Title VIII is intended to capture.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking regarding the certification requirement in
section 402(j)(5)(B) of the PHS Act (42 U.S.C. 282(j)(5)(B)). It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of applicable statutes and
regulations.

II. Comments

    Interested persons may, at any time, submit to the Division of
Dockets Management (see ADDRESSES) written or electronic comments
regarding the guidance. Submit a single copy of electronic comments or
two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments are to be identified with the docket
number found in brackets in the heading of this document. A copy of the
guidance and received comments are available for public examination in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

III. Paperwork Reduction Act of 1995

    This guidance refers to a previously approved collection of
information. This collection of information is 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 collection of information has been
approved under OMB Control No. 0910-0616.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance
document at eitherhttp://www.fda.gov/oc/initiatives/advance/fdaaa.html
or http://www.regulations.gov.

    Dated: January 15, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-1183 Filed 1-15-09; 11:15 am]

BILLING CODE 4160-01-S