[Federal Register: November 5, 2008 (Volume 73, Number 215)]
[Notices]
[Page 65868]
[DOCID:fr05no08-69]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1795-DR]

Indiana; Amendment No. 5 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 Indiana (FEMA-1795-DR), dated September 23, 2008, and
related determinations.

DATES: Effective Date: October 24, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Indiana is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the catastrophe declared a major disaster by the President in his
declaration of September 23, 2008.

    Floyd, Jackson, Lawrence, Martin, Perry, Pike, and Spencer
Counties for Public Assistance (already designated for Individual
Assistance).

    Decatur, Dubois, Franklin, Gibson, Newton, Ohio, Orange, Rush,
Union, Vanderburgh, and Warrick Counties for Public Assistance.
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.

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-26299 Filed 11-4-08; 8:45 am]

BILLING CODE 9111-23-P


IMPORTANT NOTE TO USER: February 26, 1996 This OMB form has been recreated in WP6.0 by OPPTS staff. The margins and lines are NOT block protected, so you must fill the form with caution, paying attention to any shifting of the existing text. The following tips should make this a simple task:

 Fill in the spaces by using the type over command. Otherwise you'll have to delete a space for each letter you add.

 Use the same font ( Times New Roman 8pt).

 Do not change table lines ( although you can delete an extra space line to provide more space elsewhere.

 It is not recommended that you convert this form to WP5.1, some of these features are not available in WP5.1, so the text will scramble.

If you have any problems or questions, please call your RID Desk Officer @ 260 2706. PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA/ OSWER/ OSW 2. OMB control number b. G None a. 2050 0139 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title Reporting and Recordkeeping Requirements Under EPA's WasteWise Program 8. Agency form number( s) ( If applicable) 1698.04 9. Keywords solid waste, voluntary 10. Abstract EPA needs to collect this information to evaluate the success of the voluntary WasteWise program and the progress of members participating in the program. The information is used to recognize members' achievements and identify successful waste reduction strategies to share with others. Members are predominantly businesses, as well as some non profits, trade associations, institutions, and federal, state, local, and tribal governments.

11. Affected public ( Mark primary with " P" and all others that apply with " X")

a. Individuals or households d. Farms b. P Business or other for profit e. X Federal Government c. X Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X")

a. P Voluntary b. G Required to obtain or retain benefits c. G Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 1,270 b. Total annual responses 1,740 1. Percentage of these responses collected electronically 35 % c. Total annual hours requested 64,260 d. Current OMB inventory 40,067 e. Difference 24,193 f. Explanation of difference 1. Program Change 24,193 2. Adjustment 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 0 2. Adjustment 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. P Program evaluation f. __ Research c. __ General purpose statistics g. __ Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. Q Recordkeeping b. Q Third party disclosure c. X Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. X Annually 7. Q Biennually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Barbara A. Nichols Phone: 703 308 8659 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Office Official Date Signature of Senior Official or designee Joseph Retzer, Director Regulatory Information Division Office of Regulatory Management and Information ( OPPE) Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( i) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( i) the reasons the information is planned to be and/ or has been collected; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any 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."

10/ 95


[Federal Register Volume 77, Number 13 (Friday, January 20, 2012)]
[Notices]
[Page 2968]
[FR Doc No: 2012-1082]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12790-001]

Pomperaug Hydro Project, Andrew Peklo III; Notice Establishing
Deadline for Comments and Reply Comments

    On December 15, 2011, the Commission issued notice that Office of
Energy Projects staff will hold a site visit and technical meeting on
January 18, 2012. The meeting will be transcribed by a court reporter
and all oral comments made at the meeting will be included in the
public record. Any written comments should be filed by February 17,
2012, and any reply comments must be filed by March 5, 2012. If you
have questions about filing comments, please contact Steve Kartalia at
(202) 502-6131, or via email at<EMAIL_ADDRESS>
    Dated: January 12, 2012.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2012-1082 Filed 1-19-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 123 (Tuesday, June 28, 2022)]
[Notices]
[Pages 38449-38450]
[FR Doc No: 2022-13709]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2016-0420]

Commercial Driver's License (CDL): New Prime, Inc. (Prime);
Application for Exemption Renewal

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of provisional renewal of exemption; request for
comments.

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SUMMARY: FMCSA announces its decision to provisionally renew a New
Prime, Inc., (Prime) exemption from the provisions that require a
commercial learner's permit (CLP) holder to be accompanied by a
commercial driver's license (CDL) holder with the proper CDL class and
endorsements seated in the front seat of the vehicle while the CLP
holder performs behind-the-wheel training on public roads or highways.
The exemption allows a CLP holder who has passed the skills test but
not yet received the CDL document to drive a Prime commercial motor
vehicle (CMV) accompanied by a CDL holder who is not necessarily in the
passenger seat, provided the driver has documentation of passing the
skills test. The exemption renewal is for 5 years.

DATES: This renewed exemption is effective June 28, 2022 and expires on
June 27, 2027. Comments must be received on or before July 28, 2022.

ADDRESSES: You may submit comments identified by Federal Docket
Management System (FDMS) Number FMCSA-2016-0420 by any of the following
methods:
     Federal eRulemaking Portal: www.regulations.gov. See the
Public Participation and Request for Comments section below for further
information.
     Mail: Dockets Operations, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, between 9 a.m. and 5 p.m.
E.T., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Each submission must include the Agency name and the docket number
(FMCSA-2016-0420) for this notice. Note that DOT posts all comments
received without change to www.regulations.gov, including any personal
information included in a comment. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays. To be sure someone is there to help you,
please call<PHONE_NUMBER> or<PHONE_NUMBER> before visiting Dockets
Operations.
    Privacy Act: In accordance with 49 U.S.C. 31315(b), DOT solicits
comments from the public to better inform its exemption process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice DOT/ALL 14 -FDMS, which can be reviewed at
https://www.transportation.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Ms. Bernadette Walker, Driver and
Carrier Operations Division; Office of Carrier, Driver and Vehicle
Safety Standards, FMCSA, at<PHONE_NUMBER> or by email at
[email protected]. If you have questions on viewing or submitting material
to the docket, contact Dockets Operations at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2016-0420), indicate the specific section of this
document to which the comment applies, and provide a reason for
suggestions or recommendations. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so the Agency can contact you if it has questions
regarding your submission.
    To submit your comment online, go to www.regulations.gov and put
the docket number (``FMCSA-2016-0420'') in the ``Keyword'' box, and
click ``Search.'' When the new screen appears, click on the ``Comment
Now!'' button and type your comment into the text box in the following
screen. Choose whether you are submitting your comment as an individual
or on behalf of a third party and then submit. If you submit your
comments by mail or hand delivery, submit them in an unbound format, no
larger than 8\1/2\ by 11 inches, suitable for copying and electronic
filing. If you submit comments by mail and would like to know that they
reached the facility, please enclose a stamped, self-addressed postcard
or envelope. FMCSA will consider all comments and material received
during the comment period.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315(b)(2) and 49
CFR 381.300(b) to renew an exemption from the Federal Motor Carrier
Safety Regulations for a 5-year period if it finds ``such exemption
would likely achieve a level of safety that is equivalent to, or
greater than, the level that would be achieved absent such exemption.''
Prime has requested a five-year extension of the current exemption in
Docket No. FMCSA-2016-0420.

III. Background

Current Regulatory Requirements

    FMCSA's CDL regulations provide minimum training conditions for
behind-the-wheel training of a CLP holder in 49 CFR 383.25. Section
383.25(a)(1) requires that a CLP holder must at all times be
accompanied by a CDL holder with the proper CDL class and endorsements.
The CDL holder must be seated in the front seat of the vehicle while
the CLP holder performs behind-the-wheel training on public roads or
highways.

Application for Renewal of Exemption

    FMCSA published notice of Prime's initial application for exemption
from 49 CFR 383.25(a)(1) to this docket on December 20, 2016 (81 FR
92947). That notice described the nature of Prime's operations. FMCSA
published a notice granting Prime's exemption request on June 27, 2017
(82 FR 29143), which expires on June 27, 2022. FMCSA found that Prime
would likely achieve a level of safety that was equivalent to, or
greater than, the level of safety that would be obtained by complying
with the regulation because CLP holders who have passed the CDL skills
test are qualified and eligible immediately to obtain a CDL from their
State of domicile, and then to start driving without supervision.
    Prime requests a renewal of the exemption for a 10-year period. By
statute, FMCSA may grant the renewal for no longer than 5 years (49
U.S.C. 31315(b)(2)).

IV. Equivalent Level of Safety

    FMCSA determined in 2017 that Prime drivers would likely achieve a

level of safety equivalent to, or greater than, the level of safety
achieved without the exemption. FMCSA noted in its June 27, 2017,
notice that CLP holders who have passed the CDL skills test are
qualified and eligible to obtain a CDL. If those CLP holders obtained
their CLPs and training in their State of domicile, they could
immediately receive their CDL at the State driver licensing agency and
begin driving a CMV without any on-board supervision.
    In its March 9, 2022, application for renewal, Prime states that it
has not discovered any safety issues while operating under the
exemption and that it will continue to monitor its safety data. Prime
further states that its ``lead seat'' trainers commonly own their
trucks and are therefore interested in ensuring that the CLP holder
operates the CMV safely. In addition, Prime states that once its CLP
holders have passed the CDL skills test, they continue into their
second phase of training, in which they typically log more than 30,000
miles before becoming a solo driver.
    FMCSA is unaware of any evidence of a degradation of safety
attributable to the current exemption for Prime drivers. There is no
indication of an adverse impact on safety while operating under the
terms and conditions specified in the initial exemption or exemption
renewal. Furthermore, on two previous occasions the Agency granted a
similar exemption, to CRST Expedited [81 FR 65696, September 23, 2016]
and to C.R. England [80 FR 33329, June 11, 2015].
    FMCSA concludes that provisionally extending the exemption granted
on June 27, 2017, for another five years, under the terms and
conditions listed below, will likely achieve a level of safety that is
equivalent to, or greater than, the level of safety achieved without
the exemption.

V. Exemption Decision

A. Grant of Exemption

    FMCSA provisionally renews the exemption for a period of five years
subject to the terms and conditions of this decision and the absence of
public comments that would cause the Agency to terminate the exemption
under Sec. V.F. below. The exemption from the requirements of 49 CFR
383.25(a)(1), is otherwise effective June 28, 2022, through June 27,
2027, 11:59 p.m. local time, unless renewed or rescinded.

B. Applicability of Exemption

    The exemption excuses Prime from the requirement that a driver
accompanying a CLP holder must always be physically present in the
front seat of a CMV, on the condition that the CLP holder has
successfully passed an approved CDL skills test.

C. Terms and Conditions

    When operating under this exemption, Prime and its drivers are
subject to the following terms and conditions:
    (1) Prime and its drivers must comply with all other applicable
Federal Motor Carrier Safety Regulations (49 CFR part 350-399);
    (2) The drivers must be in possession of a valid State driver's
license, CLP with the required endorsements, and documentation that
they have passed the CDL skills test;
    (3) The drivers must not be subject to any OOS order or suspension
of driving privileges; and
    (4) The drivers must be able to provide this exemption document to
enforcement officials.

D. Preemption

    In accordance with 49 U.S.C. 31315(d), as implemented by 49 CFR
381.600, during the period this exemption is in effect, no State shall
enforce any law or regulation that conflicts with or is inconsistent
with this exemption with respect to a firm or person operating under
the exemption. States may, but are not required to, adopt the same
exemption with respect to operations in intrastate commerce.

E. Notification to FMCSA

    Prime must notify FMCSA within 5 business days of any crash (as
defined in 49 CFR 390.5) involving any of its CMVs operating under the
terms of this exemption. The notification must include the following
information:
    (a) Name of the exemption: ``Prime'';
    (b) Date of the crash;
    (c) City or town, and State, in which the crash occurred, or
closest to the crash scene;
    (d) Driver's name and license number;
    (e) Vehicle number and State license number;
    (f) Number of individuals suffering physical injury;
    (g) Number of fatalities;
    (h) The police-reported cause of the crash;
    (i) Whether the driver was cited for violation of any traffic laws,
motor carrier safety regulations; and
    (j) The driver's total driving time and total on-duty time prior to
the crash.
    Reports filed under this provision shall be emailed to
[email protected]

F. Termination

    FMCSA does not believe the drivers covered by this exemption will
experience any deterioration of their safety record. The exemption will
be rescinded if: (1) Prime and drivers operating under the exemption
fail to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
before it was granted; or (3) continuation of the exemption would not
be consistent with the goals and objects of 49 U.S.C. 31136(e) and
31315.

VI. Request for Comments

    In accordance with 49 U.S.C. 31315(b), FMCSA requests public
comment from all interested persons on Prime, Inc.'s application for an
exemption from the requirement in 49 CFR 383.25(a)(1) that would allow
CLP holders who have successfully passed a CDL skills test and are
eligible to receive, but have not yet obtained, a CDL to drive a CMV
without a CDL holder in the front passenger seat. All comments received
before the close of business on the comment closing date indicated at
the beginning of this notice will be considered and will be available
for examination in the docket at the location listed under the
Addresses section of this notice. Comments received after the comment
closing date will be filed in the public docket and will be considered
to the extent practicable. In addition to late comments, FMCSA will
also continue to file, in the public docket, relevant information that
becomes available after the comment closing date. Interested persons
should continue to examine the public docket for new material.

Robin Hutcheson,
Deputy Administrator.
[FR Doc. 2022-13709 Filed 6-27-22; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Pages 69645-69646]
[FR Doc No: 2012-28116]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3360-EM; Docket ID FEMA-2012-0002]

New Hampshire; Amendment No. 1 to Notice of an Emergency
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of an emergency declaration for
the State of New Hampshire (FEMA-3360-EM), dated October 30, 2012, and
related determinations.

DATES: Effective Date: November 3, 2012.

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: The notice of an emergency declaration for
the State of New Hampshire is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared an emergency by the President in his declaration of
October 30, 2012.

    The counties of Belknap, Carroll, Cheshire, Coos, Grafton,
Hillsborough, Merrimack, Rockingham, Stafford, and Sullivan for
emergency protective measures (Category B), including direct federal
assistance, under the Public Assistance program.

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. 2012-28116 Filed 11-19-12; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8861-8862]
[FR Doc No: 2015-03442]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EC15-73-000.
    Applicants: Bayonne Energy Center, LLC, Zone J Tolling Co., LLC.
    Description: Application for Authorization for Disposition of
Jurisdictional Facilities and Request for Expedited Action of Bayonne
Energy Center, LLC, et. al.
    Filed Date: 2/12/15.
    Accession Number: 20150212-5127.
    Comments Due: 5 p.m. ET 3/5/15.

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

    Docket Numbers: ER10-1908-009; ER10-1909-009; ER10-1910-009;ER10-
1911-009.

    Applicants: Duquesne Keystone, LLC, Duquesne Light Company,
Duquesne Power, LLC, Duquesne Conemaugh, LLC.
    Description: Notice of Non-Material Change in Status of the
Duquesne MBR Sellers.
    Filed Date: 2/12/15.
    Accession Number: 20150212-5078.
    Comments Due: 5 p.m. ET 3/5/15.

    Docket Numbers: ER10-2808-002.
    Applicants: Freeport-McMoran Copper & Gold Energy Services, LLC.
    Description: Notice of Non-Material Change in Status of Freeport-
McMoran Copper & Gold Energy Services, LLC.
    Filed Date: 2/11/15.
    Accession Number: 20150211-5270.
    Comments Due: 5 p.m. ET 3/4/15.

    Docket Numbers: ER10-2964-005; ER11-2041-005; ER11-2042-005; ER10-
3193-004.
    Applicants: Innovative Energy Systems, LLC, Seneca Energy II, LLC,
Selkirk Cogen Partners, L.P., Brooklyn Navy Yard Cogeneration Partners,
L.P.
    Description: Second Supplement to June 30, 2014 Order No. 697
Triennial Compliance Filing of Selkirk Cogen Partners, L.P., et. al.
    Filed Date: 2/11/15.
    Accession Number: 20150211-5271.
    Comments Due: 5 p.m. ET 2/23/15.

    Docket Numbers: ER12-673-006; ER12-672-006; ER12-674-007; ER12-670-
007; ER10-2374-008; ER10-1533-010.
    Applicants: Brea Generation LLC, Brea Power II, LLC, Macquarie
Energy LLC, Puget Sound Energy, Inc., Rhode Island Engine Genco, LLC,
Rhode Island LFG Genco, LLC.
    Description: Notice of Non-Material Change in Status of Brea
Generation LLC, et. al.
    Filed Date: 2/12/15.
    Accession Number: 20150212-5081.
    Comments Due: 5 p.m. ET 3/5/15.

    Docket Numbers: ER14-2657-001.
    Applicants: El Paso Electric Company.
    Description: Compliance filing per 35: Compliance Filing with Jan
12, 2015 Order in ER14-2657-000 to be effective 10/13/2014.
    Filed Date: 2/11/15.
    Accession Number: 20150211-5232.
    Comments Due: 5 p.m. ET 3/4/15.

    Docket Numbers: ER14-2711-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Report Filing: 2015-02-12_Order 719 Supplement the
Record to be effective N/A.
    Filed Date: 2/12/15.
    Accession Number: 20150212-5149.
    Comments Due: 5 p.m. ET 3/5/15.

    Docket Numbers: ER15-743-001.
    Applicants: Appalachian Power Company.
    Description: Tariff Amendment per 35.17(b): OATT--Revise
Attachments K & L, TCC & TNC Rate Update Amendment to be effective 12/
29/2014.
    Filed Date: 2/11/15.
    Accession Number: 20150211-5237.
    Comments Due: 5 p.m. ET 3/4/15.

    Docket Numbers: ER15-1026-000.
    Applicants: Utah Red Hills Renewable Park, LLC.
    Description: Initial rate filing per 35.12 Application for Market-
Based Rate Authorization to be effective 5/1/2015.
    Filed Date: 2/11/15.
    Accession Number: 20150211-5266.
    Comments Due: 5 p.m. ET 3/4/15.

    Docket Numbers: ER15-1027-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii): 2965
SWEPCO/Rayburn Country Elec Coop/ETEC Interconnect Agr. to be effective
4/13/2015.
    Filed Date: 2/12/15.
    Accession Number: 20150212-5055.
    Comments Due: 5 p.m. ET 3/5/15.

    Docket Numbers: ER15-1028-000.
    Applicants: California Independent System Operator Corporation.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii): 2015-
02-12_AguaCalienteLGIAConcurrence to be effective 10/21/2014.
    Filed Date: 2/12/15.
    Accession Number: 20150212-5062.
    Comments Due: 5 p.m. ET 3/5/15.

    Docket Numbers: ER15-1029-000.
    Applicants: Chubu TT Energy Management Inc.
    Description: Initial rate filing per 35.12 Chubu TT MBRA
Application to be effective 4/15/2015.
    Filed Date: 2/12/15.
    Accession Number: 20150212-5086.
    Comments Due: 5 p.m. ET 3/5/15.

    Docket Numbers: ER15-1030-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii):
Service Agreement No. 3058; Queue Nos. U2-073/Z2-013 to be effective 1/
13/2015.
    Filed Date: 2/12/15.
    Accession Number: 20150212-5120.
    Comments Due: 5 p.m. ET 3/5/15.

    Docket Numbers: ER15-1031-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii):
Original Service Agreement No. 4086; Queue Position Y3-037 to be
effective 1/13/2015.
    Filed Date: 2/12/15.
    Accession Number: 20150212-5130.
    Comments Due: 5 p.m. ET 3/5/15.

    Docket Numbers: ER15-1032-000.
    Applicants: Midcontinent Independent System Operator.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii): 2015-
02-12_SA 1519 MDU-Tatanka 5th Rev. GIA (G132/J249) to be effective 2/
13/2015.
    Filed Date: 2/12/15.
    Accession Number: 20150212-5147.
    Comments Due: 5 p.m. ET 3/5/15.

    Take notice that the Commission received the following PURPA
210(m)(3) filings:

    Docket Numbers: QM15-1-000.
    Applicants: Virginia Electric and Power Company.
    Description: Motion for Leave to Answer and Answer to Community
Energy Solar, LLC, LLC, Community Energy Renewables, LLC and Nine
Affiliated Entities January 14, 2015 Answer, of Virginia Electric and
Power Company.
    Filed Date: 2/11/15.
    Accession Number: 20150211-5272.
    Comments Due: 5 p.m. ET 3/11/15.

    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: February 12, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-03442 Filed 2-18-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49377-49379]
[FR Doc No: 2017-23173]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0655]

Animal Generic Drug User Fee Act; Recommendations; Request for
Comments; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comments; extension of
comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of the Animal Generic Drug User Fee Act
(AGDUFA) reauthorization draft recommendations and extending the
comment period to allow interested persons 30 days to submit comments
on these draft recommendations.

DATES: FDA is extending the comment period on the AGDUFA
reauthorization and draft recommendations. Submit either electronic or
written comments on the draft recommendations by November 24, 2017.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 24, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 24, 2017. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-N-0655 for ``Animal Generic Drug User Fee Act;
Recommendations; Request for Comments; Extension of Comment Period''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The

second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Cassie Ravo, Center for Veterinary
Medicine (HFV-10), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of the proposed recommendations
for the reauthorization of AGDUFA, which authorizes FDA to collect user
fees and use them for the process of reviewing generic new animal drug
applications and associated submissions. The authority for AGDUFA
expires September 30, 2018. Without new legislation, FDA will no longer
have the authority to collect user fees to fund the generic new animal
drug review process for future fiscal years. Section 742(d)(4) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j-
22(d)(4)) requires that, after holding negotiations with regulated
industry and periodic consultations with stakeholders, and before
transmitting the Agency's final recommendation to Congress for the
reauthorized program (AGDUFA III), we do the following: (1) Present the
recommendations to the relevant Congressional committees, (2) publish
such recommendations in the Federal Register, (3) provide for a period
of 30 days for the public to provide written comments on such
recommendations, (4) hold a meeting at which the public may present its
views on such recommendations, and (5) consider such public views and
comments and revise such recommendations as necessary. In the Federal
Register of October 5, 2017 (82 FR 46506), we announced a public
meeting to be held on November 2, 2017. In that notice we stated that
we intended to publish in the Federal Register the full text of the
proposed AGDUFA III Performance Goals and Procedures Letter and a
summary of proposed statutory changes, as well as post them at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm270232.htm, before the public meeting and would provide for a period
of 30 days for the public to provide written comments. This notice
announces the availability of these draft recommendations and extends
the comment period to November 24, 2017 to provide for a period of 30
days for the public to comment on these draft recommendations. After
the public meeting and closing of the comment period, we will revise
the draft recommendations as necessary. In addition, the Agency will
present the draft recommendations to the Congressional committees.

II. Proposed AGDUFA III Recommendations

A. Enhancing the Process for Premarket Review

    We are proposing the following changes to the performance
commitments previously established to further enhance the process for
review of generic new animal drug applications.
    Beginning October 1, 2018, all applications and submissions under
section 512(b) of the FD&C Act (21 U.S.C. 360b(b)) must be submitted to
the Agency electronically using the eSubmitter tool.
    The Agency will review and act on 90 percent of original
abbreviated new animal drug applications (ANADAs) within 240 days (180-
day review plus 60-day administrative review) after the submission
date. An application is incomplete if it would require additional data
or information to enable the Agency to complete a comprehensive review
of the application and reach a decision on the issue(s) presented in
the application. If the Agency determines that the deficiencies are not
substantial, the Agency will review and act on 90 percent of
reactivated applications within 120 days (60-day review plus 60-day
administrative review) after the reactivated ANADA submission date.
This shorter review time for reactivated ANADAs for which the
deficiencies are determined not to be substantial is not intended to
prevent the use of minor amendments during Agency review of an
application. If the Agency determines that the deficiencies are
substantial or new substantial information is provided, the Agency will
review and act on 90 percent of reactivated applications within 240
days (180-day review plus 60-day administrative review) after the
reactivated ANADA submission date.
    The Agency will review and act on 90 percent of administrative
ANADAs (ANADAs submitted after all scientific decisions have been made
in the generic investigational new animal drug (JINAD) process, i.e.,
prior to the submission of the ANADA) within 60 days after the
submission date. Paragraph IV certification applications (section
512(n)(1)(H)(iv) of the FD&C Act) submitted as administrative ANADAs
will be excluded from the administrative ANADA cohort.
    The Agency will review and act on 90 percent of Prior Approval
manufacturing supplemental ANADAs within 180 days after the submission
date. A Prior Approval manufacturing supplemental ANADA includes: One
or more major manufacturing changes according to Sec.  514.8(b)(2)(ii)
(21 CFR 514.8(b)(2)(ii)) and in accordance with Guidance for Industry
#83, ``Chemistry, Manufacturing, and Controls Changes to an Approved
NADA or ANADA''; and changes submitted as ``Supplement-Changes Being
Effected in 30 Days'' that require prior approval according to Sec.
514.8(b)(3)(v)(A). If a Prior Approval supplement does not clearly
identify any major manufacturing changes, the Prior Approval supplement
will be designated by the Agency as a ``Supplement--Changes Being
Effected'' with a 270-day review goal (see ``Supplement--Changes Being
Effected Manufacturing Supplemental ANADAs and Reactivations'' below).
    A submission is incomplete if it requires additional data or
information to enable the Agency to complete a comprehensive review of
the submission and reach a decision on the issue(s) presented in the
submission. If the Agency determines that the deficiencies are not
substantial for manufacturing supplements requiring prior approval, the
Agency will allow the manufacturing supplements to be resubmitted as
``Supplement-Changes Being Effected in 30 Days'' as described

in Sec.  514.8(b)(3) and the drug made with the change can be
distributed 30 days after the resubmission according to Sec.
514.8(b)(3)(iv). The Agency will review and act on 90 percent of these
reactivated manufacturing supplements within 270 days after the
resubmission date of a complete submission. If the Agency determines
that the deficiencies remain substantial or new substantial information
is provided, prior approval is required according to Sec.
514.8(b)(3)(v)(A). The Agency will review and act on 90 percent of
these reactivated manufacturing supplements within 180 days after the
resubmission date of a complete submission.
    The Agency will review and act on 90 percent of ``Supplement-
Changes Being Effected'' manufacturing supplemental ANADAs and
reactivations submitted according to Sec.  514.8(b)(3)(vi) and in
accordance with Guidance for Industry #83, ``Chemistry, Manufacturing,
and Controls Changes to an Approved NADA or ANADA,'' including
manufacturing changes not requiring prior approval according to Sec.
514.8(b)(3)(iv), within 270 days after the submission date.
    The Agency will review and act on 90 percent of JINAD study
submissions within 180 days after the submission date.
    A submission is incomplete if it would require additional data or
information to enable the Agency to complete a comprehensive review of
the study submission and reach a decision on the issue(s) presented in
the submission. If the Agency determines that the deficiencies are not
substantial, the Agency will review and act on 90 percent of
resubmitted JINAD study submissions within 60 days after the receipt
date of a complete study submission. This shorter review time for
resubmitted JINAD study submissions is not intended to prevent the use
of minor amendments during Agency review of a study submission. If the
Agency determines that the deficiencies are substantial or new
substantial information is provided, the Agency will review and act on
90 percent of resubmitted JINAD study submissions within 180 days after
the receipt date of a complete study submission.
    The Agency will review and act on 90 percent of JINAD submissions
consisting of protocols without substantial data, that the Agency and
the sponsor consider to be an essential part of the basis for making
the decision to approve or not approve an ANADA or supplemental ANADA,
within 75 days after the submission date.
    The Agency will allow comparability protocols as described in Sec.
514.8(b)(2)(v) to be submitted as protocols without substantial data in
a JINAD file. The Agency will review and act on 90 percent of JINAD
submissions consisting of protocols without substantial data within 75
days after the submission date of the protocol. For potentially more
complex comparability protocols, for example sterile process validation
protocols, the sponsor should discuss and have Agency concurrence
regarding the appropriate filing strategy.
    The Agency will continue to allow two-phased Chemistry,
Manufacturing, and Controls technical section submissions under the
JINAD process.
    The Agency and regulated industry are committed to improving the
review and business processes that will facilitate the timely
scheduling and conducting of pre-approval inspections (PAIs). To
improve the timeliness and predictability of foreign PAIs, sponsors may
voluntarily submit: (1) At the beginning of the calendar year, a list
of foreign manufacturing facilities that are specified in an
abbreviated application, supplemental abbreviated application, or
generic investigational file and may be subject to foreign PAIs for the
following fiscal year; and (2) a notification 30 days prior to
submitting an abbreviated application, a supplemental abbreviated
application, or generic investigational file that informs the Agency
that the application includes a foreign manufacturing facility. Should
any changes to the annual list occur after its submission to the
Agency, the sponsor may provide the updated information to the Agency.
    The Agency will keep a record of the number of foreign PAIs
conducted for abbreviated applications, along with the average time for
completing the PAIs, and include this information in its annual
performance report. The time for completing the PAI is understood to
mean the time from the inspection scheduling request through
notification to the Center for Veterinary Medicine (CVM) of
inspectional findings.
    The Agency and regulated industry agree that the use of both formal
meetings (e.g., pre-submission conferences, workshops) and informal
communication by both parties is critical to ensure high submission
quality such that the above performance goals can be achieved.

B. Inflation Adjuster and Workload Adjuster

    The Agency and regulated industry agree to change the current fixed
4 percent inflation adjuster to a variable inflation adjuster
calculated using payroll cost and benefits and the Consumer Price Index
less food and energy.
    The workload adjustment will continue to be calculated per CVM
Program Policy and Procedures Manual 1243.3022, except that, for
purposes of calculating the workload adjustment, it is agreed to reset
the base years to fiscal year (FY) 2014 through FY 2018. There will be
no workload adjustment for FY 2019. Workload adjustments are one-time
adjustments and are calculated annually.

C. Offset Provision and Excess Collections

    The proposal adds financial flexibility by eliminating the final
year offset of the over collections provision and making any excess
collections available to enhance the review process in real time. In
addition, the proposal provides authority for the Secretary of Health
and Human Services when setting fees to reduce a calculated workload
adjustment up to the amount of excess collections in the second
preceding fiscal year. The first fiscal year this provision could be
applied while setting fees is fiscal year 2021.

D. Impact of AGDUFA III Changes on User Fee Revenue

    The FY 2019 baseline for AGDUFA III is $18,336,340. For each year
from FY 2020 through FY 2023, the annual statutory revenue amounts
established in section 741(b) of the FD&C Act (21 U.S.C. 379j-21(b))
will be further adjusted according to the new statutory provision for
the inflation adjuster and may be further adjusted by the workload
adjuster, if applicable.
    The planned total 5-year revenue for AGDUFA I was $27,100,000. The
planned total 5-year revenue for AGDUFA II was $38,100,000, which also
included one-time information technology funding in the amount of
$850,000 for FY 2014. It is estimated that the planned total 5-year
revenue for AGDUFA III will be $95,000,000.
    The fee revenue distribution in AGDUFA III will remain the same as
AGDUFA II: 25 percent in application fees; 37.5 percent in product
fees; and 37.5 percent in sponsor fees.

    Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23173 Filed 10-24-17; 8:45 am]
BILLING CODE 4164-01-P


                    POLICY & STRATEGY COMMITTEE MEETING
                          Thursday, December 13, 2018
                    DCI Group, 1828 L Street NW, Suite 400

10:00 am	Welcome and purpose of the meeting
 Chair  --  Mike Carey, Murray Energy
 Vice Chair  --  Heather Teilhet, Oglethorpe
10:15 am	Perspectives on the Affordable Clean Energy Rule
 Stephen Fotis, Van Ness Feldman
                  Stephen will provide an overview of comments that states filed on the proposed ACE rule.
 Reid Harvey, Director, Clean Air Markets Division, EPA
                  Mr. Harvey will discuss the timeline for implementing the ACE rule, how EPA and the states will approach implementation, and what challenges EPA and the states face.
 Allison Wood, Hunton Andrews Kurth, representing the Utility Air Regulatory Group
                  UARG represents more than 30 electric generating companies, including several ACCCE members.  In addition, ACCCE, NRECA and EEI are members of UARG.
 Thomas Wells, Southern Company
                  Southern is one of the nation's largest electricity generators with 46,000 MW of electric generating capacity.
 Mike Pullen, VP Production, Big Rivers
                  Big Rivers Electric Corporation is a generation and transmission cooperative (G&T) headquartered in Henderson, Kentucky.

Noon	Lunch
12:45 pm    Discussion of ACCCE Priorities for 2019
            This is a continuation of the discussion the Committee started at its October meeting.  The issues that were discussed briefly at that time included wholesale electricity markets, ACE rule, CCR rule, NSR and tax incentives.   In addition, it would be helpful to discuss ideas for ACCCE messaging on climate change.
2:00 pm	Adjourn


[Federal Register Volume 82, Number 137 (Wednesday, July 19, 2017)]
[Notices]
[Pages 33141-33142]
[FR Doc No: 2017-15177]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2016-0896; OMB Control Number: 1625-0084]

Collection of Information Under Review by Office of Management
and Budget

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting approval for
reinstatement, without change, of the following collection of
information: 1625-0084, Audit Reports under the International Safety
Management Code. Our ICR describes the information we seek to collect
from the public. Review and comments by OIRA ensure we only impose
paperwork burdens commensurate with our performance of duties.

DATES: Comments must reach the Coast Guard and OIRA on or before August
18, 2017.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2016-0896] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. Alternatively, you
may submit comments to OIRA using one of the following means:
    (1) Email<EMAIL_ADDRESS>    (2) Mail: OIRA, 725 17th Street NW., Washington, DC 20503,
attention Desk Officer for the Coast Guard.
    A copy of the ICR is available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
COMMANDANT (CG-612), ATTN: PAPERWORK REDUCTION ACT MANAGER, U.S. COAST
GUARD, 2703 MARTIN LUTHER KING JR AVE SE., STOP 7710, WASHINGTON, DC
20593-7710.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection. The Coast Guard invites comments on whether
this ICR should be granted based on the Collection being necessary for
the proper performance of Departmental functions. In particular, the
Coast Guard would appreciate comments addressing: (1) The practical
utility of the Collection; (2) the accuracy of the estimated burden of
the Collection; (3) ways to enhance the quality, utility, and clarity
of information subject to the Collection; and (4) ways to minimize the
burden of the Collection on respondents, including the use of automated
collection techniques or other forms of information technology. These
comments will help OIRA determine whether to approve the ICR referred
to in this Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2016-0896], and must be received by August 18,
2017.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that Web site's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Number: 1625-0084.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard has published the 60-day notice (81 FR 85991, November 29,
2016) required by 44 U.S.C. 3506(c)(2). That Notice elicited no
comments. Accordingly, no changes have been made to the Collections.

Information Collection Request

    Title: Audit Reports under the International Safety Management
Code.
    OMB Control Number: 1625-0084.
    Summary: This information helps to determine whether U.S. vessels,
subject to SOLAS 74, engaged in international trade, are in compliance
with that treaty. Organizations recognized by the Coast Guard conduct
ongoing audits of vessels' and companies' safety management systems.
    Need: Title 46 U.S.C. 3203 authorizes the Coast Guard to prescribe
regulations regarding safety management systems. Title 33 CFR part 96
contains the rules for those systems and hence the safe operation of
vessels.
    Forms: N/A.
    Respondents: Owners and operators of vessels, and organizations
authorized to issue ISM Code certificates for the United States.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has decreased from
17,660 hours to 10,221 hours a year due to a decrease in the estimated
annual number of response.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: July 12, 2017.
Marilyn Scott-Perez,
U.S. Coast Guard, Chief, Office of Information Management.
[FR Doc. 2017-15177 Filed 7-18-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 189 (Monday, September 30, 2013)]
[Notices]
[Pages 60014-60015]
[FR Doc No: 2013-23766]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2013-0020]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt 16 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions will enable these individuals to operate CMVs in
interstate commerce.

DATES: The exemptions are effective September 30, 2013. The exemptions
expire on September 30, 2015.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Room
W64-224, Department of Transportation, 1200 New Jersey Avenue SE.,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, or other
entity). You may review DOT's Privacy Act Statement for the Federal
Docket Management System (FDMS) published in the Federal Register on
January 17, 2008 (73 FR 3316).

Background

    On June 26, 2013, FMCSA published a notice of receipt of Federal
diabetes exemption applications from 16 individuals and requested
comments from the public (78 FR 38439). The public comment period
closed on July 26, 2013, and two comments were received.
    FMCSA has evaluated the eligibility of the 16 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher

rate of crash involvement than the general population. The diabetes
rule provides that ``A person is physically qualified to drive a
commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    These 16 applicants have had ITDM over a range of 1 to 28 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the past 5 years. In each case,
an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes-related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the June 26, 2013, Federal Register
notice and they will not be repeated in this notice.

Discussion of Comments

    FMCSA received two comments in this proceeding. The comments are
considered and discussed below.
    Laurie Susan Palmer expressed concern regarding the new A1C testing
regulations.
    John D. Heffington requested information regarding the new A1C
testing regulations.

Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in a CMV or personal vehicle, whether or not it is
related to an episode of hypoglycemia; (3) that each individual provide
a copy of the ophthalmologist's or optometrist's report to the medical
examiner at the time of the annual medical examination; and (4) that
each individual provide a copy of the annual medical certification to
the employer for retention in the driver's qualification file, or keep
a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the certification when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

Conclusion

    Based upon its evaluation of the 16 exemption applications, FMCSA
exempts Tyler A. Benjamin (AL), Larry K. Brindle (KS), James D. Damske
(MA), Manuel M. Fabela, Jr. (CA), Ryan L. Guffey (IL), Richard B.
Harvey (CA), Donald F. Kurzejewski (PA), Joshua O. Lilly (VA), Steven
C. Lundberg (IA), Frank D. Marcou, Jr. (VT), Roger D. Mott (IA),
Bernard K. Nixon (FL), Thomas P. Olson (WI), Steven T. Vanderburg (NC),
John P. Washington (NJ), and Christopher J. Wisner (MD) from the ITDM
requirement in 49 CFR 391.41(b)(3), subject to the conditions listed
under ``Conditions and Requirements'' above.
    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption will
be valid for two years unless revoked earlier by FMCSA. The exemption
will be revoked if the following occurs: (1) The person fails to comply
with the terms and conditions of the 1/exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: September 20, 2013.
Larry W. Minor,
 Associate Administrator for Policy.
[FR Doc. 2013-23766 Filed 9-27-13; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 76, Number 119 (Tuesday, June 21, 2011)]
[Notices]
[Pages 36133-36134]
[FR Doc No: 2011-15344]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0429]

Draft Guidances for Industry and Food and Drug Administration
Staff: Classification of Products as Drugs and Devices and Additional
Product Classification Issues; and Interpretation of the Term
``Chemical Action'' in the Definition of Device Under Section 201(h) of
the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of two related draft guidances for industry and FDA staff
entitled ``Draft Guidance for Industry and FDA Staff: Classification of
Products as Drugs and Devices and Additional Product Classification
Issues'' and ``Draft Guidance for Industry and FDA Staff:
Interpretation of the Term 'Chemical Action' in the Definition of
Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic
Act.'' These draft guidances provide the Agency's current thinking on
approaches for classifying products as drugs and devices, certain
additional product classification issues, and the interpretation of the
term ``chemical action'' under the FD&C Act.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
these draft guidances before it begins work on the final versions of
these guidances, submit either electronic or written comments on the
draft guidances by September 19, 2011.

ADDRESSES: Submit written requests for single copies of these draft
guidances to the Office of Combination Products, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive

label to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
    Submit electronic comments on the draft guidances to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of
Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of two draft guidances for
industry and FDA staff entitled ``Draft Guidance for Industry and FDA
Staff: Classification of Products as Drugs and Devices and Additional
Product Classification Issues'' (Draft Classification Guidance) and
``Draft Guidance for Industry and FDA Staff: Interpretation of the Term
'Chemical Action' in the Definition of Device Under Section 201(h) of
the Federal Food, Drug, and Cosmetic Act'' (Draft Chemical Action
Guidance). These draft guidances provide the Agency's current thinking
on approaches for classifying products as drugs and devices, certain
additional product classification issues, and the interpretation of the
term ``chemical action'' under section 201(h).
    FDA determines whether to classify a product as a drug or device
based on the statutory definitions for these terms set forth in
sections 201(g) and 201(h) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act)(21 U.S.C. 321(g) and 321(h)), respectively, as applied
to the scientific data concerning the product that are available to FDA
at the time the classification determination is made.
    The Draft Classification Guidance addresses three topics: (1) It
explains how to obtain a formal classification determination for a
medical product; (2) it presents the Agency's current thinking on the
interpretation of the statutory definitions of device and drug, other
than the term ``chemical action'' in the definition of device at
section 201(h), which is addressed in the Draft Chemical Action
Guidance, as discussed in the following paragraphs; and (3) it presents
the Agency's current thinking on the status of published intercenter
jurisdictional agreements, current regulations establishing
classifications, and classifications the Agency has otherwise
previously made for specific products.
    The definition of device at section 201(h) states, in part, that a
device ``does not achieve its primary intended purposes through
chemical action within or on the body of man or other animals.'' The
term ``chemical action'' in this phrase is often important in
determining whether a product meets the definition of device at section
201(h). The Draft Chemical Action Guidance presents the Agency's
current thinking on the interpretation of the term ``chemical action''
for purposes of this definition. The Draft Chemical Action Guidance
states that a product exhibits chemical action if: ``through either
chemical reaction or intermolecular forces or both, the product
mediates a bodily response at the cellular or molecular level, or
combines with or modifies an entity so as to alter that entity's
interaction with the body of man or other animals.''
    The Agency welcomes all comments on the Draft Classification
Guidance and the Draft Chemical Action Guidance. In particular, we
request comment on the following two topics:
    1. Application of the approaches articulated in these two draft
guidances to specific groups of products.
    We seek input on how groups of products would be classified under
these approaches and the regulatory implications of those
classifications. While we welcome more general input on the approaches
announced, we are seeking particular comments regarding the application
of these approaches to specific products or groups of products. We note
that questions concerning whether to classify a product as a drug or
device have most frequently arisen with respect to products consisting
of gels, liquids, semi-liquids, or powders that come into contact with
the body.
    We also seek input on whether or how to clarify or modify any
elements or terms of the approaches presented. For example, the
approach for whether a product exhibits chemical action quoted
previously from the Draft Chemical Action Guidance includes the phrase
``mediates a bodily response at the cellular or molecular level.'' We
welcome input on this phrase or any other aspect of this approach.
    2. Relationship between these classification approaches and prior
classification determinations.
    As noted previously, the Draft Classification Guidance discusses
the Agency's current thinking on the status of the current published
intercenter jurisdictional agreements, regulations establishing
classifications, and other classifications of specific products (e.g.,
via marketing authorizations or requests for designation). We seek
comment on the concepts presented in this section of the Draft
Classification Guidance. For example, we welcome comment on procedures
for determining whether to change current product classifications and,
if so, how to implement those changes appropriately.
    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the Agency's current thinking on
classification of products as drugs and devices, certain additional
product classification issues, and the interpretation of the term
``chemical action'' under section 201(h). They do not create or confer
any rights for or on any person and do not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.
    The draft guidance on classification of products as drugs or
devices refers to previously approved collections of information found
in FDA regulations. These collections of information are subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in 21 CFR part 3 have been approved under OMB control
number 0910-0523.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding these
documents. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15344 Filed 6-20-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 11 (Wednesday, January 18, 2017)]
[Notices]
[Pages 5583-5584]
[FR Doc No: 2017-00969]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0113]

The Prohibition of Distributing Free Samples of Tobacco Products;
Draft Guidance for Industry; 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 draft guidance for industry entitled ``The
Prohibition of Distributing Free Samples of Tobacco Products; Draft
Guidance for Industry.'' The draft guidance, when finalized, would
provide information intended to assist manufacturers, distributors, and
retailers in complying with the regulations prohibiting the
distribution of free samples of tobacco products.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 17, 2017.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-0113 for ``The Prohibition of Distributing Free Samples of
Tobacco 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 Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets

Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Center for Tobacco Products, Food and Drug Administration, Document
Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
the office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT: Paul Hart or Samantha Loh Collado,
Center for Tobacco Products, Food and Drug Administration, Document
Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002, 1-877-287-1373<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``The Prohibition of Distributing Free Samples of Tobacco
Products; Draft Guidance for Industry.'' Title 21 of the Code of
Federal Regulations (CFR) section 1140.16(d)(1) prohibits, with a
limited exception, tobacco product manufacturers, distributors, and
retailers from distributing or causing to be distributed any free
samples of cigarettes, smokeless tobacco, or other tobacco products.
The draft guidance describes, among other things, how the prohibition
of distributing free samples of tobacco products applies to non-
monetary exchanges, coupons and discounts, membership and rewards
programs, contests and games of chance, and the business-to-business
exchange of free samples. FDA requests that interested parties submit
comments concerning its draft interpretation of the prohibition of
distributing free samples.

II. Significance of Draft Guidance

    FDA is issuing this draft guidance consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``The
Prohibition of Distributing Free Samples of Tobacco 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.

III. Electronic Access

    Persons with access to the Internet may obtain an electronic
version of the draft guidance at either https://www.regulations.gov or
http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

    Dated: January 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00969 Filed 1-17-17; 8:45 am]
 BILLING CODE 4164-01-P