[Federal Register Volume 78, Number 188 (Friday, September 27, 2013)]
[Notices]
[Pages 59665-59666]
[FR Doc No: 2013-23572]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

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

    Docket Numbers: EC13-152-000.
    Applicants: Capital Power Investments LLC, Rumford Power Inc.,
Emera Incorporated.
    Description: Joint Application for Authorization of Disposition of
Securities and Facilities Under Section 203 of the Federal Power Act,
Request for Expedited Consideration and Waivers, and Request for
Privileged Treatment of Capital Power, et al.
    Filed Date: 9/20/13.
    Accession Number: 20130920-5051.
    Comments Due: 5 p.m. ET 10/11/13.

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

    Docket Numbers: ER13-77-002.
    Applicants: Tucson Electric Power Company.
    Description: OATT Order No. 1000 Regional Compliance Filing
(September 2013) to be effective 12/31/9998.
    Filed Date: 9/20/13.
    Accession Number: 20130920-5065.
    Comments Due: 5 p.m. ET 10/21/13.

    Docket Numbers: ER13-78-002.
    Applicants: UNS Electric, Inc.
    Description: OATT Order No. 1000 Regional Compliance Filing
(September 2013) to be effective 12/31/9998.
    Filed Date: 9/20/13.
    Accession Number: 20130920-5066.
    Comments Due: 5 p.m. ET 10/21/13.

    Docket Numbers: ER13-79-002.
    Applicants: Public Service Company of New Mexico.
    Description: Order 1000 IntraRegional Compliance Filing to be
effective 12/31/9998.
    Filed Date: 9/20/13.
    Accession Number: 20130920-5032.
    Comments Due: 5 p.m. ET 10/21/13.

    Docket Numbers: ER13-82-002.
    Applicants: Arizona Public Service Company.
    Description: OATT Order No. 1000 Compliance Filing to be effective
12/31/9998.
    Filed Date: 9/20/13.
    Accession Number: 20130920-5064.
    Comments Due: 5 p.m. ET 10/21/13.

    Docket Numbers: ER13-1225-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: 09-20-2013 Sch 43B Harbor Beach Comp Filing to be
effective 10/1/2012.
    Filed Date: 9/20/13.
    Accession Number: 20130920-5062.
    Comments Due: 5 p.m. ET 10/11/13.
    Docket Numbers: ER13-2169-000.
    Applicants: Goal Line L.P.
    Description: Supplement to August 16, 2013 Goal Line L.P. tariff
filing.
    Filed Date: 9/20/13.
    Accession Number: 20130920-5055.

    Comments Due: 5 p.m. ET 10/11/13.

    Docket Numbers: ER13-2408-000.
    Applicants: ISO New England Inc., Bangor Hydro Electric Company.
    Description: BHE and ISO-NE Filing of New LSAs to be effective 9/
19/2013.
    Filed Date: 9/20/13.
    Accession Number: 20130920-5063.
    Comments Due: 5 p.m. ET 10/11/13.

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

    Docket Numbers: ES13-56-000.
    Applicants: Transource Missouri, LLC.
    Description: Application of Transource Missouri, LLC for
Authorization Under Section 204(A) of the Federal Power Act to Borrow
Up to $350 Million.
    Filed Date: 9/20/13.
    Accession Number: 20130920-5059.
    Comments Due: 5 p.m. ET 10/11/13.

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

    Dated: September 20, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-23572 Filed 9-26-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 38 (Monday, March 1, 2021)]
[Notices]
[Page 12045]
[FR Doc No: 2021-04139]

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SECURITIES AND EXCHANGE COMMISSION

[Extension Form Id 3235-0328]

Submission for OMB Review; Comment Request; Upon Written Request

Copies Available From: Securities and Exchange Commission, Office of
FOIA Services, 100 F Street NE, Washington, DC 20549-2736

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.) (the ``Paperwork Reduction Act''),
the Commission is soliciting comments on the collection of information
summarized below. The Commission plans to submit this existing
collection of information to the Office of Management and Budget.
    Form ID (OMB Control No. 3235-0328) must be completed and filed
with the Commission by all individuals, companies, and other
organizations who seek access to file electronically on the
Commission's primary electronic filing system, Electronic Data
Gathering, Analysis and Retrieval system (``EDGAR''). Those seeking
access to file on EDGAR typically include those who are required to
make certain disclosures pursuant to the federal securities laws. The
information provided on Form ID is an essential part of the security of
EDGAR. Form ID is not a public document because it is used solely for
the purpose of screening applicants and granting access to EDGAR. Form
ID must be submitted whenever an applicant seeks an EDGAR
identification number (Central Index Key or CIK) and access codes to
file on EDGAR.
    The Commission may consider, among other things, amendments to Form
ID that would result in a more uniform and secure process for EDGAR
access by requiring certain applicants that already have a CIK, but do
not have EDGAR access codes, to submit the Form ID to obtain access to
EDGAR. If these amendments are adopted, for purposes of the Paperwork
Reduction Act, the estimated total number of annual Form ID filings for
filers with CIKs that need to obtain access codes is approximately 404
filings.\1\ Additionally, we would update the current approved estimate
of the annual number of Form ID filings for new filers without CIKs
(46,842 filings) by approximately 1,247 filings.\2\
---------------------------------------------------------------------------

    \1\ We base this estimate on the average number of filers with
CIKs who have obtained access codes to EDGAR for the past three
fiscal years. (524 + 359 + 330)/3 = 404.
    \2\ We base this estimate on the number of Form ID filings for
filers with no CIKs for the past three fiscal years and subtracting
it from the current approved estimate. ((49,269 + 48,136 + 46,861)/
3) - 46,842 = 1,247.
---------------------------------------------------------------------------

    Thus, for purposes of the Paperwork Reduction Act, the estimated
total number of annual Form ID filings would increase from 46,842
filings to 48,493 filings.\3\ The estimate of 0.15 hours per response
would stay the same, as the filers with CIKs would be filling out the
same information as filers without CIKs. The estimated total annual
burden would increase from 7,026 hours to 7,274 hours.\4\ The estimate
that the filers are responsible for 100% of the total burden hours
would stay the same.
---------------------------------------------------------------------------

    \3\ 46,842 + 404 + 1,247 = 48,493.
    \4\ 48,493 x 0.15 = 7,274.
---------------------------------------------------------------------------

    In relation to the potential amendments described above, the
Commission may consider amending the Form ID to delete references to
applicants that do not have CIKs. If adopted, this amendment would
clarify that a Form ID submission would also be required by applicants
that already have CIKs but do not have EDGAR access codes. Separately,
the Commission may also consider modifying Form ID to update its
instructions and cross-references to Volume I of the EDGAR Filer
Manual.\5\
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    \5\ See Adoption of Updated EDGAR Filer Manual, Proposed
Collection and Comment Request for Form ID, Release No. 33-10902
(Dec. 11, 2020) [86 FR 7968] (Feb. 3, 2021)] (allowing applicants to
EDGAR the option of obtaining electronic notarizations and remote
online notarizations). The Commission also amended 17 CFR 232.10(b)
to remove the manual signature requirement for EDGAR access requests
to allow electronic signature requests. Id. The methods of
notarization provide an efficient means of authenticating signatures
in connection with requests for EDGAR access.
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    Other than the potential amendments to require certain applicants
that already have a CIK, but do not have EDGAR access codes, to submit
the Form ID, we do not believe that these additional amendments to the
Form ID would make any substantive modifications to any existing
collection of information requirements or impose any new substantive
recordkeeping or information collection requirements within the meaning
of the Paperwork Reduction Act.
    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 control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
to (i) www.reginfo.gov/public/do/PRAMain and (ii) David Bottom,
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Cynthia Roscoe, 100 F Street NE, Washington, DC 20549, or by
sending an email to<EMAIL_ADDRESS>
    Dated: February 24, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-04139 Filed 2-26-21; 8:45 am]
BILLING CODE 8011-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on July 6, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST-2004-17733

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:   African International Airways (Proprietary) Limited
Date Filed:  May 6, 2004

Relief requested:  Exemption from 49 U.S.C. § 41301 to engage in
charter foreign air transportation of property and mail between South
Africa, on the one hand, and the United States, on the other hand, and
authority to conduct other all-cargo charters in accordance with Part
212 of the Department rules.

If renewal, date and citation of last action:  New authority

Applicant representatives:  Moffett B. Roller/Lee A. Bauer<PHONE_NUMBER>

DOT Analyst:  Shelita A. Smith—(202) 366-1226

Responsive pleadings:  None

DISPOSITION

Action:  Approved								Action date:  July 6, 2004

Effective dates of authority granted:  July 6, 2004 – July 6, 2005

Basis for approval (bilateral agreement/reciprocity):  Reciprocity with
South Africa

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

X  Standard exemption conditions (attached)

Special conditions/Partial grant/Denial basis/Remarks:  Based on the
record in this case, we found that African International Airways is
financially and operationally qualified to perform the services
authorized above.  While South African citizens hold the majority
interest in African International Airways, because of the ownership
interest of non-homeland citizens, the record in the case does not
permit us to make definitive findings that African International Airways
is substantially owned and effectively controlled by nationals of South
Africa.  Specifically, African International Airways is 76% owned by two
citizens of South Africa and 24% owned by Intavia Limited, a company
wholly owned by two citizens of the United Kingdom.   However, we found
that it was consistent with the public interest to use our discretion
and to waive our ownership and control standard in this instance.  After
carefully examining the record in this case, we concluded that there was
no evidence that the non-homeland ownership of African International
Airways would result in its authority being exercised in a manner that
would adversely affect U.S. aviation policy or interests.  Finally, by
Memorandum dated May 17, 2004, the FAA advised us that it knows of no
reason why the Department should act unfavorably on African
International Airways’ application.

Action taken by:  Paul L. Gretch, Director

		   Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) the applicant is qualified to perform the
proposed operations; (2) our action was consistent with Department
policy; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied

all requests in the referenced Docket.  We may amend, modify, or revoke
the authority granted in this Notice at any time without hearing at our
discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

Foreign Carrier Exemption Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

  Intavia Limited leases aircraft to African International Airways and
provides, under contract, day-to-day management services to the
applicant.

05/2004


[Federal Register Volume 76, Number 149 (Wednesday, August 3, 2011)]
[Notices]
[Page 46829]
[FR Doc No: 2011-19543]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1996-DR; Docket ID FEMA-2011-0001]

Montana; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Montana (FEMA-1996-DR), dated June 17, 2011, and
related determinations.

DATES: Effective Date: July 22, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, 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 disaster is closed effective July 22, 2011.

(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.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-19543 Filed 8-2-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: November 29, 2010 (Volume 75, Number 228)]
[Rules and Regulations]
[Page 72935-72939]
[DOCID:fr29no10-2]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 13

[Docket No. FAA-2009-0237; Amendment No. 13-35]
RIN 2120-AJ50

Revisions to the Civil Penalty Inflation Adjustment Tables

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This final rule adjusts for inflation the minimum and maximum
civil monetary penalty amounts the FAA may impose for violations of the
statutes and regulations it enforces in order to continue the deterrent
effect of these penalties. The adjustments are made following a formula
provided by Congress.

DATES: This amendment becomes effective December 29, 2010.

FOR FURTHER INFORMATION CONTACT: Cole Milliard, Office of the Chief
Counsel, Enforcement Division, AGC-300, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591.
Telephone<PHONE_NUMBER>. Facsimile<PHONE_NUMBER>. E-mail
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules on aviation safety is found in
Title 49 of the United States Code. Subtitle I, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
    This rulemaking is issued under the Federal Civil Penalties
Inflation Adjustment Act of 1990, Public Law (Pub. L.) 101-410, as
amended by the Debt Collection Improvement Act of 1996, Public Law 104-
134, codified at 28 U.S.C. 2461 note. These laws authorize the FAA to
adjust the minimum and maximum amounts of civil monetary penalties for
violations of the statues it enforces to preserve their deterrent
effect.

Good Cause for Immediate Adoption of This Final Rule

    The FAA finds that good cause exists under 5 U.S.C. 553(b)(B) for
adopting

this final rule without notice and comment. This rule effectuates the
intent of the Federal Civil Penalties Inflation Adjustment Act to allow
for regular adjustment, for inflation, of civil monetary penalties to
preserve the deterrent effect of civil monetary penalties and promote
compliance with the law. The inflation adjustments to penalties under
this rule apply a formula mandated by Congress. Thus, it is unnecessary
to delay these adjustments to receive public comment. Such comments
would not allow the FAA to develop any basis to change the method or
application of the mandatory inflation adjustments.

Discussion

Background

    Under the Debt Collection Improvement Act of 1996, the FAA must
adjust all applicable civil monetary penalties at least once every 4
years. In doing so, the FAA must also apply a formula Congress included
in the Debt Collection Improvement Act of 1996 to determine the amount
of increase to each of its civil monetary penalties. Both of these
requirements are included in 28 U.S.C. 2461 note.

Prior FAA Rulemakings

    In 1996 (61 FR 67445; December 20, 1996), we added subpart H, Civil
Monetary Penalty Inflation Adjustment, to 14 CFR part 13. Subpart H
implements the terms of 28 U.S.C. 2461 note. We also made our initial
adjustment to the civil monetary penalties applicable to the FAA's
enforcement program in that rulemaking. The current rulemaking is the
FAA's third adjustment of its civil monetary penalties since the
regulation was adopted. Previous adjustments were made in 2002
(Amendment No. 13-31; 67 FR 6364; February 11, 2002) and 2006
(Amendment No. 13-33; 71 FR 47 28518; May 16, 2006). The 2006
adjustment also incorporated in Subpart H several statutory changes to
our authority to impose civil penalties.

This Rulemaking

    In this rulemaking, we adjust the civil penalty amounts listed in
Tables 2 and 3 of 14 CFR part 13, subpart H, for inflation in
accordance with the formula set forth in Subpart H. Under subpart H, we
determine the inflation adjustment for each applicable civil penalty by
increasing the maximum civil penalty or the range of minimum and
maximum civil penalties by the ``cost-of-living adjustment'' (COLA).
The COLA is ``the percentage (if any) for each civil monetary penalty
by which the Consumer Price Index (CPI) for the month of June of the
calendar year preceding the adjustment exceeds the CPI for the month of
June of the calendar year in which the amount of such civil penalty was
last set or adjusted pursuant to law.'' Each increase is rounded off as
described in 14 CFR 13.305(a) and the rounded-off increase is added to
the existing civil penalty amount. For the initial adjustment of a
civil penalty under Subpart H, the increase is limited to ten percent
of the civil penalty amount, as stated in 14 CFR 13.305(c).
    For this rulemaking, we looked at the increase of the CPI for June
2009 over the CPIs for the years in which each civil penalty amount was
last set, reset, or adjusted. The words ``set'' and ``reset'' in this
context indicate that Congress has added to or changed the FAA's
statutory authority to impose civil monetary penalties. The word
``adjusted'' indicates a change we made under Subpart H.

Civil Penalty Inflation Adjustment

Relevant CPI's

    The CPI for June 2009 was 215.693. The CPI for the month of June of
the calendar years in which civil monetary penalty amounts were last
set, reset, or adjusted are:
    (1) 160.3 for June 1997;
    (2) 183.7 for June 2003;
    (3) 194.5 for June 2005; and
    (4) 202.9 for June 2006.

                                  COLAs
------------------------------------------------------------------------
              Year                 COLA calculation       COLA amount
------------------------------------------------------------------------
1997............................       215.693/160.3      1.346 (134.6%)
2003............................       215.693/183.7      1.174 (117.4%)
2005............................       215.693/194.5      1.109 (110.9%)
2006............................       215.693/202.9      1.063 (106.3%)
------------------------------------------------------------------------

Round-off Formula

    (1) Multiple of $10, in the case of penalties less than or equal to
$100;
    (2) Multiple of $100, in the case of penalties greater than $100
but less than or equal to $1,000;
    (3) Multiple of $1,000, in the case of penalties greater than
$1,000 but less than or equal to $10,000;
    (4) Multiple of $5,000, in the case of penalties greater than
$10,000 but less than $100,000;
    (5) Multiple of $10,000, in the case of penalties greater than
$100,000 but less than or equal to $200,000;
    (6) Multiple of $25,000, in the case of penalties greater than
$200,000.

Results of Calculations for Inflation Adjustment

    Using the methodology outlined in 28 U.S.C. 2461 note and
implemented in 14 CFR part 13 subpart H, we have determined that
several of our civil monetary penalties should be adjusted. The
adjusted civil monetary penalty amounts are set forth in ``Table of
Minimum and Maximum Civil Monetary Penalty Amounts for Certain
Violations Occurring on or After December 29, 2010'', which will be
located in 14 CFR 13.305(d).

Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires
that the FAA consider the impact of paperwork and other information
collection burdens imposed on the public. The FAA has determined that
there is no new requirement for information collection associated with
this final rule.

International Compatibility

    In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to conform to
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the maximum extent practicable. The FAA has
determined that there are no ICAO Standards and Recommended Practices
that correspond to these regulations.

Regulatory Notices and Analyses

    Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 directs that each Federal agency
must propose or adopt a regulation only upon a reasoned determination
that the benefits of the intended regulation justify its costs. Second,
the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires

agencies to analyze the economic impact of regulatory changes on small
entities. Third, the Trade Agreements Act (Pub. L. 96-39) forbids
agencies from setting standards that create unnecessary obstacles to
the foreign commerce of the United States. In developing U.S.
standards, this Trade Act requires agencies to consider international
standards and, where appropriate, that they be the basis of U.S.
standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4) requires agencies to prepare a written assessment of the costs,
benefits, and other effects of proposed or final rules that include a
Federal mandate likely to result in the expenditure by State, local, or
Tribal governments, in the aggregate, or by the private sector, of $100
million or more annually (adjusted for inflation with base year of
1995). This portion of the preamble summarizes the FAA's analysis of
the economic impacts of this final rule.
    Department of Transportation Order DOT 2100.5 prescribes policies
and procedures for simplification, analysis, and review of regulations.
If the expected cost impact is so minimal that a proposed or final rule
does not warrant a full evaluation, this order permits that a statement
to that effect and the basis for it is included in the preamble if a
full regulatory evaluation of the cost and benefits is not prepared.
Such a determination has been made for this final rule. The reasoning
for this determination follows:
    This final rule simply identifies the civil monetary penalties for
violations of the statutory and regulatory provisions we enforce. The
penalty amounts are those specified by statute or called for under the
inflation adjustment statutes, and the information in this rule is
required by the Debt Collection Improvement Act of 1996. Its economic
impact is minimal.
    Also, we determined that this final rule is not a ``significant
regulatory action'' as defined in section 3(f) of Executive Order
12866, and is not ``significant'' as defined in DOT's Regulatory
Policies and Procedures.

Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA)
establishes ``as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of applicable
statutes, to fit regulatory and informational requirements to the scale
of the businesses, organizations, and governmental jurisdictions
subject to regulation. To achieve this principle, agencies are required
to solicit and consider flexible regulatory proposals and to explain
the rationale for their actions to assure that such proposals are given
serious consideration.'' The RFA covers a wide-range of small entities,
including small businesses, not-for-profit organizations, and small
governmental jurisdictions.
    Agencies must perform a review to determine whether a rule will
have a significant economic impact on a substantial number of small
entities. If the agency determines that it will, the agency must
prepare a regulatory flexibility analysis as described in the RFA.
    However, if an agency determines that a rule is not expected to
have a significant economic impact on a substantial number of small
entities, section 605(b) of the RFA provides that the head of the
agency may so certify and a regulatory flexibility analysis is not
required. The certification must include a statement providing the
factual basis for this determination, and the reasoning should be
clear.
    This final rule simply identifies the civil monetary penalties for
violations of the statutory and regulatory provisions we enforce. The
penalty amounts are those specified by statute or called for under the
inflation adjustment statutes, and the information in this rule is
required by the Debt Collection Improvement Act of 1996. Its economic
impact is minimal.
    Therefore, as the FAA Administrator, I certify that this rule will
not have a significant economic impact on a substantial number of small
entities.

International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the
Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal
agencies from establishing any standards or engaging in related
activities that create unnecessary obstacles to the foreign commerce of
the United States. Pursuant to these Acts, the establishment of
standards is not considered an unnecessary obstacle to the foreign
commerce of the United States, so long as the standards have a
legitimate domestic objective, such as the protection of safety, and do
not operate in a manner that excludes imports that meet this objective.
The statute also requires consideration of international standards and,
where appropriate, that they be the basis for U.S. standards.
    This rule only summarizes civil monetary penalties, established by
legislation, for violations of statutory and regulatory provisions that
apply equally to domestic and foreign entities; therefore, we have
determined that this rule will not result in an impact on international
trade by companies doing business in or with the United States.

Unfunded Mandates Reform Assessment

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement
assessing the effects of any Federal mandate in a proposed or final
agency rule that may result in an expenditure of $100 million or more
(adjusted annually for inflation with the base year 1995) in any one
year by State, local, and Tribal governments, in the aggregate, or by
the private sector; such a mandate is deemed to be a ``significant
regulatory action.'' The level equivalent of $100 million in CY 1995,
adjusted for inflation to CY 2007 levels by the Consumer Price Index
for all Urban Consumers (CPI-U) as published by the Bureau of Labor
Statistics, is $143.1 million.
    This final rule does not contain such a mandate since it only
identifies the increase in penalties as required by the Debt Collection
Improvement Act of 1996. Therefore, the requirements of Title II of the
Act do not apply.

Executive Order 13132, Federalism

    The FAA has analyzed this final rule under the principles and
criteria of Executive Order 13132, Federalism. We determined that this
action will not have a substantial direct effect on the States, or the
relationship between the national Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. Therefore, the FAA has determined that this final rule does
not have federalism implications.

Environmental Analysis

    FAA Order 1050.1E identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined this rulemaking action qualifies for the categorical
exclusion and involves no extraordinary circumstances.

Regulations That Significantly Affect Energy Supply, Distribution, or
Use

    The FAA analyzed this final rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (May 18, 2001). The agency has determined that it
is not a ``significant energy action'' under the executive order and it
is not likely to

have a significant adverse effect on the supply, distribution, or use
of energy.

Availability of Rulemaking Documents

    You can get an electronic copy using the Internet by:
    (1) Searching the Federal eRulemaking Portal at http://
www.regulations.gov;
    (2) Visiting the FAA's Regulations and Policies Web page at http://
www.faa.gov/regulations_policies/; or
    (3) Accessing the Government Printing Office's Web page at http://
www.gpoaccess.gov/fr/index.html.
    You can also get a copy by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling<PHONE_NUMBER>. Make
sure to identify the amendment number or docket number of this
rulemaking.
    Anyone is able to search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit
http://www.regulations.gov.

Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act (SBREFA) of
1996 requires FAA to comply with small entity requests for information
or advice about compliance with statutes and regulations within its
jurisdiction. If you are a small entity and you have a question
regarding this document, you may contact your local FAA official, or
the person listed under the FOR FURTHER INFORMATION CONTACT heading at
the beginning of the preamble. You can find out more about SBREFA on
the Internet at http://www.faa.gov/regulations_policies/rulemaking/
sbre_act/.

List of Subjects in CFR 14 Part 13

    Administrative practice and procedure, Air transportation,
Hazardous materials transportation, Investigations, Law enforcement,
Penalties.

The Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends Chapter I of title 14, Code of Federal Regulations as follows:

PART 13--INVESTIGATIVE AND ENFORCEMENT PROCEDURES

0
1. The authority citation for part 13 continues to read as follows:

    Authority:  18 U.S.C. 6002, 28 U.S.C. 2461 (note); 49 U.S.C.
106(g), 5121-5124, 40113-40114, 44103-44106, 44702-44703, 44709-
44710, 44713, 44718, 44725, 46101-46110, 46301-46316, 46318, 46501-
46502, 46504-46507, 47106, 47111, 47122, 47306, 47531- 47532.

0
2. Amend Sec.  13.305(d) by removing Tables 1 through 3 and adding a
new table in their place to read as follows:

Sec.  13.305  Cost of living adjustments of civil monetary penalties.

* * * * *
    (d) * * *

               Table of Minimum and Maximum Civil Monetary Penalty Amounts for Certain Violations Occurring On or After December 29, 2010
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Maximum penalty
                                      Civil monetary penalty       Minimum penalty        New or adjusted     amount when last set     New or adjusted
      United States Code cite               description                 amount            minimum penalty     or adjusted pursuant     maximum penalty
                                                                                amount                 to law                amount
--------------------------------------------------------------------------------------------------------------------------------------------------------
49 U.S.C. 5123(a), subparagraph     Violation of hazardous      $250 per violation,    No change...........  $50,000 per            $55,000 per
 (1).                                materials transportation    reset 8/10/2005.                             violation, reset 8/    violation.
                                     law.                                                                     10/2005.
49 U.S.C. 5123(a), subparagraph     Violation of hazardous      $250 per violation,    No change...........  $100,000 per           $110,000 per
 (2).                                materials transportation    reset 8/10/2005.                             violation, set 8/10/   violation.
                                     law resulting in death,                                                  2005.
                                     serious illness, severe
                                     injury, or substantial
                                     property destruction.
49 U.S.C. 5123(a), subparagraph     Violation of hazardous      $450 per violation,    No change...........  $50,000 per            $55,000 per
 (3).                                materials transportation    set 8/10/2005.                               violation, set 8/10/   violation.
                                     law relating to training.                                                2005.
49 U.S.C. 46301(a)(1).............  Violation by a person       N/A..................  N/A.................  $25,000 per            $27,500 per
                                     other than an individual                                                 violation, reset 12/   violation.
                                     or small business concern                                                12/2003.
                                     under 49 CFR
                                     46301(a)(1)(A) or (B).
49 U.S.C. 46301(a)(1).............  Violation by an airman      N/A..................  N/A.................  $1,100 per violation,  No change.
                                     serving as an airman                                                     reset 12/12/2003.
                                     under 49 U.S.C.
                                     46301(a)(1)(A) or (B)
                                     (but not covered by
                                     46301(a)(5)(A) or (B).
49 U.S.C. 46301(a)(1).............  Violation by an individual  N/A..................  N/A.................  $1,100 per violation,  No change.
                                     or small business concern                                                reset 12/12/2003.
                                     under 49 U.S.C.
                                     46301(a)(1)(A) or (B)
                                     (but not covered in 49
                                     U.S.C. 46301(a)(5)).
49 U.S.C. 46301(a)(3).............  Violation of 49 U.S.C.      N/A..................  N/A.................  Increase above         No change.
                                     47107(b) (or any                                                         otherwise applicable
                                     assurance made under such                                                maximum amount not
                                     section) or 49 U.S.C.                                                    to exceed 3 times
                                     47133.                                                                   the amount of
                                                                                revenues that are
                                                                                used in violation of
                                                                                such section.

49 U.S.C. 46301(a)(5)(A)..........  Violation by an individual  N/A..................  N/A.................  $11,000 per            No change.
                                     or small business concern                                                violation, adjusted
                                     (except an airman serving                                                6/15/2006.
                                     as an airman) under 49
                                     U.S.C. 46301(a)(5)(A)(i)
                                     or (ii).
49 U.S.C. 46301(a)(5)(B)(i).......  Violation by an individual  N/A..................  N/A.................  $11,000 per            No change.
                                     or small business concern                                                violation, adjusted
                                     related to the                                                           6/15/2006.
                                     transportation of
                                     hazardous materials.
49 U.S.C. 46301(a)(5)(B)(ii)......  Violation by an individual  N/A..................  N/A.................  $11,000 per            No change.
                                     or small business concern                                                violation, adjusted
                                     related to the                                                           6/16/2006.
                                     registration or
                                     recordation under 49
                                     U.S.C. chapter 441, of an
                                     aircraft not used to
                                     provide air
                                     transportation.
49 U.S.C. 46301(a)(5)(B)(iii).....  Violation by an individual  N/A..................  N/A.................  $11,000 per            No change.
                                     or small business concern                                                violation, adjusted
                                     of 49 U.S.C. 44718(d),                                                   6/15/2006.
                                     relating to limitation on
                                     construction or
                                     establishment of
                                     landfills.
49 U.S.C. 46301(a)(5)(B)(iv)......  Violation by an individual  N/A..................  N/A.................  $11,000 per            No change.
                                     or small business concern                                                violation, adjusted
                                     of 49 U.S.C. 44725,                                                      6/15/2006.
                                     relating to the safe
                                     disposal of life-limited
                                     aircraft parts.
49 U.S.C. 46301(b)................  Tampering with a smoke      N/A..................  N/A.................  $2,200 per violation,  $3,200 per
                                     alarm device.                                                            adjusted 1/21/1997.    violation.
49 U.S.C. 46302...................  Knowingly providing false   N/A..................  N/A.................  $11,000 per            $16,000 per
                                     information about alleged                                                violation, adjusted    violation.
                                     violation involving the                                                  1/21/1997.
                                     special aircraft
                                     jurisdiction of the
                                     United States.
49 U.S.C. 46318...................  Interference with cabin or  N/A..................  N/A.................  $27,500, adjusted 6/   No change.
                                     flight crew.                                                             15/2006.
49 U.S.C. 46319...................  Permanent closure of an     N/A..................  N/A.................  $11,000 per day,       No change.
                                     airport without providing                                                adjusted 6/15/2006.
                                     sufficient notice.
49 U.S.C. 47531...................  Violation of 49 U.S.C.      N/A..................  N/A.................  See 49 U.S.C.          No change.
                                     47528-47530, relating to                                                 46301(a)(1)(A) and
                                     the prohibition of                                                       (a)(5), above.
                                     operating certain
                                     aircraft not complying
                                     with stage 3 noise levels.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Issued in Washington, DC on November 22, 2010.
J. Randolph Babbitt,
Administrator.
[FR Doc. 2010-29920 Filed 11-26-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 128 (Tuesday, July 3, 2012)]
[Notices]
[Pages 39493-39494]
[FR Doc No: 2012-16304]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9696-5]

Proposed Consent Decree, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed consent decree; request for public comment.

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

SUMMARY: In accordance with section 113(g) of the Clean Air Act, as
amended (``CAA''), notice is hereby given of a proposed consent decree,
to address a lawsuit filed by Sierra Club in the United States District
Court for the District of Columbia: Sierra Club v. Jackson, No. 1: 12-
cv-00012 (CKK). On March 2, 2012, the Plaintiff filed a First Amended
Complaint alleging that EPA failed to perform nondiscretionary duties
under the Clean Air Act related to the attainment of National Ambient
Air Quality Standards (NAAQS) for ozone in the Houston-Galveston-
Brazoria area. Specifically, the Plaintiff alleged that EPA failed to
take timely action to approve, disapprove, or approve in part and
disapprove in part, pursuant to CAA, portions of the State of Texas'
State Implementation Plan (SIP) submittals for the 1997 8-hour ozone
NAAQS, including an ozone attainment demonstration, contingency
provisions, reasonably available control technology requirements,
reasonable further progress provisions, and transportation control
measures and demonstrations in the Houston-Galveston-Brazoria area. The
proposed consent decree establishes deadlines for EPA to take action on
the SIP submittals listed in the consent decree. The proposed consent
decree also provides that once EPA has completed the actions specified
in the decree the case will be dismissed with prejudice.

DATES: Written comments on the proposed consent decree must be received
by August 2, 2012.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2012-0516, online at www.regulations.gov (EPA's preferred method);
by email to<EMAIL_ADDRESS>mailed to EPA Docket Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001; or by hand delivery or courier to
EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday,
excluding legal holidays. Comments on a disk or CD-ROM should be
formatted in Word or ASCII file, avoiding the use of special characters
and any form of encryption, and may be mailed to the mailing address
above.

FOR FURTHER INFORMATION CONTACT: Kaytrue Ting, Air and Radiation Law
Office (2344A), Office of General Counsel, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460;
telephone:<PHONE_NUMBER>; fax number<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Consent Decree

    The proposed consent decree would resolve a lawsuit filed by the
Sierra Club seeking to compel the Administrator to take final action
under sections 110(k)(2) and (3) of the CAA, 42 U.S.C. 7410(k)(2) and
(3), on portions of the State of Texas' State Implementation Plan (SIP)
submittals for the 1997 8-hour ozone NAAQS. Specifically, the lawsuit
seeks to compel the Administrator to take final action, pursuant to
section 110(k) of the CAA, 42 U.S.C. 7410(k), on several SIP submittals
related to 1997 8-hour ozone NAAQS nonattainment area requirements in
the Houston-Galveston-Brazoria area, including: an ozone attainment
demonstration submitted to EPA on or about April 6, 2010; contingency
provisions submitted to EPA on or about April 1, 2010; reasonably
available control technology requirements submitted to EPA on or about
June 13, 2007; reasonable further progress provisions submitted to EPA
on or about April 1, 2010; and transportation control measures and
demonstrations submitted to EPA on or about April 6, 2010.
    The proposed consent decree provides various dates by which EPA
must take proposed and final action on the SIP submittals at issue.
Following signature of each proposed and final rule described in the
proposed consent decree, EPA is required to send the notice to the
Office of the Federal Register promptly for review and publication in
the Federal Register. The proposed consent decree also states that
after EPA fulfills its obligations under the consent decree, this case
shall be dismissed with prejudice.
    For a period of thirty (30) days following the date of publication
of this notice, the Agency will accept written comments relating to the
proposed consent decree from persons who were not named as parties or
intervenors to the litigation in question. EPA or the Department of
Justice may withdraw or withhold consent to the proposed consent decree
if the comments disclose facts or considerations that indicate that
such consent is inappropriate, improper, inadequate, or inconsistent
with the requirements of the Act. Unless EPA or the Department of
Justice determines, based on any comment submitted, that consent to
this consent decree should be withdrawn, the terms of the decree will
be affirmed.

II. Additional Information About Commenting on the Proposed Consent
Decree

A. How can I get a copy of the consent decree?

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC- 2012-0516) contains a copy of the proposed consent
decree. The official public docket is available for public viewing at
the Office of Environmental Information (OEI) Docket in the EPA Docket
Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington,
DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OEI Docket is<PHONE_NUMBER>.
    An electronic version of the public docket is available through
www.regulations.gov. You may use the www.regulations.gov to submit or
view public comments, access the index listing of the contents of the
official public docket, and to access those documents in the public
docket that are available electronically. Once in the system, key in
the appropriate docket identification number then select ``search''.
    It is important to note that EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing online at www.regulations.gov without change, unless
the comment contains copyrighted material, CBI, or other information
whose disclosure is

restricted by statute. Information claimed as CBI and other information
whose disclosure is restricted by statute is not included in the
official public docket or in the electronic public docket. EPA's policy
is that copyrighted material, including copyrighted material contained
in a public comment, will not be placed in EPA's electronic public
docket but will be available only in printed, paper form in the
official public docket. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the EPA Docket Center.

B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section.
Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an email address or other
contact information in the body of your comment and with any disk or
CD-ROM you submit. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. Any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
    Use of the www.regulations.gov Web site to submit comments to EPA
electronically is EPA's preferred method for receiving comments. The
electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, email address, or other
contact information unless you provide it in the body of your comment.
In contrast to EPA's electronic public docket, EPA's electronic mail
(email) system is not an ``anonymous access'' system. If you send an
email comment directly to the Docket without going through
www.regulations.gov, your email address is automatically captured and
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: June 26, 2012.
Lorie J. Schmidt,
Associate General Counsel.
[FR Doc. 2012-16304 Filed 7-2-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 8, 2009 (Volume 74, Number 66)]
[Notices]
[Page 16028]
[DOCID:fr08ap09-118]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59627; File No. SR-NYSEAmex-2009-02]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by NYSE Amex LLC Formally
Adopting and Codifying Its Wireless Data Communications Initiatives

April 2, 2009.
    Correction: In FR Document No. E9-7291, published on Wednesday,
April 1, 2009, beginning on page 14834, third column, first paragraph,
fifth line, the name of the exchange is corrected to read ``NYSE Amex
LLC''.

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E9-7973 Filed 4-7-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 85, Number 234 (Friday, December 4, 2020)]
[Notices]
[Pages 78337-78338]
[FR Doc No: 2020-26700]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4739]

Requesting FDA Feedback on Combination Products; Guidance for
Industry and FDA Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry and FDA staff
entitled ``Requesting FDA Feedback on Combination Products.'' The
purpose of this guidance is to discuss ways in which combination
product sponsors can obtain feedback from FDA on scientific and
regulatory questions and to describe best practices for FDA and
sponsors when interacting on these topics. These interactions can occur
through application-based mechanisms, such as the pre-submission
process used in the Center for Devices and Radiological Health (CDRH)
and the Center for Biologics Evaluation and Research (CBER) and the
formal meetings used in the Center for Drug Evaluation and Research
(CDER) and CBER, or through Combination Product Agreement Meetings
(CPAMs), as appropriate.

DATES: The announcement of the guidance is published in the Federal
Register on December 4, 2020.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-4739 for ``Requesting FDA Feedback on Combination
Products.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the to
the Office of Combination Products, Food and Drug Administration, Bldg.
32, Rm. 5129, 10903 New Hampshire Ave., Silver Spring, MD 20993. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Melissa Burns, Office of Combination
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 5125,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Requesting FDA Feedback on Combination Products.'' The
purpose of this guidance is to discuss ways in which combination
product sponsors can obtain feedback from the Agency on scientific and
regulatory questions. These interactions can occur through application-
based mechanisms, such as the pre-submission process used in

CDRH and CBER and the formal meetings used in CDER and CBER, or through
CPAMs, as appropriate.
    FDA is publishing this guidance consistent with the Agency's
ongoing commitment to enhancing clarity and transparency regarding
regulatory considerations for combination products, and in accordance
with the mandate under section 503(g)(8)(C)(vi) of the Federal Food,
Drug, and Cosmetics Act (FD&C Act) (21 U.S.C. 353(g)(8)(C)(vi)), which
was added by section 3038 of the 21st Century Cures Act (Pub. L. 114-
255). Section 503(g)(8)(C)(vi) of the FD&C Act requires FDA to issue a
final guidance addressing: (1) The structured process for managing pre-
submission interactions with sponsors developing combination products;
(2) best practices to ensure FDA feedback in such pre-submission
interactions represents the Agency's best advice based on the
information provided during these pre-submission interactions; and (3)
how CPAMs relate to other FDA meeting types, what information should be
submitted prior to a CPAM, and the form and content of agreements
reached through a CPAM.
    In response to comments received on the draft guidance, this final
guidance includes additional information on use of CPAMs and
application-based mechanisms. The guidance also provides additional
clarity on how CPAMs will be conducted, including expected timelines
for CPAM-related activities.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Requesting FDA Feedback on Combination
Products.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information pertaining to orphan drug provisions in 21 CFR part 316
are approved under OMB control number 0910-0167; the collections of
information pertaining to investigational device exemption submission
provisions in 21 CFR part 812 are approved under OMB control number
0910-0078; the collections of information pertaining to investigational
new drug submission provisions in 21 CFR part 312 are approved under
OMB control number 0910-0014; the collections of information pertaining
to biologics licensing submission provisions in 21 CFR part 601 are
approved under OMB control number 0910-0338; and the collections of
information pertaining to combination product agreement meetings are
approved under OMB control number 0910-0523.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/combination-products/guidance-regulatory-information/combination-products-guidance-documents or https://www.regulations.gov.

    Dated: November 30, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26700 Filed 12-3-20; 8:45 am]
BILLING CODE 4164-01-P