[Federal Register: April 29, 2009 (Volume 74, Number 81)]
[Proposed Rules]
[Page 19471]
[DOCID:fr29ap09-24]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2008-0898; FRL-8898-5]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Transportation Conformity Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to approve the State Implementation Plan (SIP)
revision submitted by the Commonwealth of Pennsylvania for
Transportation Conformity Requirements. In the Final Rules section of
this Federal Register, EPA is approving the State's SIP submittal as a
direct final rule without prior proposal because the Agency views this
as a noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this action,
no further activity is contemplated. If EPA receives adverse comments,
the direct final rule will be withdrawn and all public comments
received will be addressed in a subsequent final rule based on this
proposed rule. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time.

DATES: Comments must be received in writing by May 29, 2009.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2008-0898 by one of the following methods:
    A. http://www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. E-mail<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2008-0898, Carol Febbo, Chief, Energy,
Radiation and Indoor Environment Branch, Mailcode 3AP23, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2008-0898. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI (or otherwise protected) through http://
www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access system'', which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. 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. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://
www.regulations.gov or in hard copy during normal business hours at the
Air Protection Division, U.S. Environmental Protection Agency, Region
III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the
State submittal are available at Pennsylvania Department of
Environmental Protection, Bureau of Air Quality Control, Rachel Carson
State Office Building, 400 Market Street, 12th Floor, Harrisburg, PA
17105-8468.

FOR FURTHER INFORMATION CONTACT: Martin Kotsch,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For further information, please see the
information provided in the direct final action, with the same title,
that is located in the ``Rules and Regulations'' section of this
Federal Register publication.

    Dated: April 15, 2009.
William C. Early,
Acting Regional Administrator, Region III.
[FR Doc. E9-9842 Filed 4-28-09; 8:45 am]

BILLING CODE 6560-50-P


CFR Excerpts
The following pages are excerpts from the Code of Federal Regulations, taken from http://www.ecfr.gov/ as of February 24, 2015.

TITLE 40 -- Protection of Environment
PART 123 -- STATE PROGRAM REQUIREMENTS
Subpart B -- State Program Submissions
*   *   *   *   *
§123.31   Requirements for eligibility of Indian Tribes.
    (a) Consistent with section 518(e) of the CWA, 33 U.S.C. 1377(e), the Regional Administrator will treat an Indian Tribe as eligible to apply for NPDES program authority if it meets the following criteria:
    (1) The Indian Tribe is recognized by the Secretary of the Interior.
    (2) The Indian Tribe has a governing body carrying out substantial governmental duties and powers.
    (3) The functions to be exercised by the Indian Tribe pertain to the management and protection of water resources which are held by an Indian Tribe, held by the United States in trust for the Indians, held by a member of an Indian Tribe if such property interest is subject to a trust restriction on alienation, or otherwise within the borders of an Indian reservation.
    (4) The Indian Tribe is reasonably expected to be capable, in the Regional Administrator's judgment, of carrying out the functions to be exercised, in a manner consistent with the terms and purposes of the Act and applicable regulations, of an effective NPDES permit program.
    (b) An Indian Tribe which the Regional Administrator determines meets the criteria described in paragraph (a) of this section must also satisfy the State program requirements described in this part for assumption of the State program.
[58 FR 67981, Dec. 22, 1993, as amended at 59 FR 64343, Dec. 14, 1994]

§123.32   Request by an Indian Tribe for a determination of eligibility.
An Indian Tribe may apply to the Regional Administrator for a determination that it qualifies pursuant to section 518 of the Act for purposes of seeking NPDES permit program approval. The application shall be concise and describe how the Indian Tribe will meet each of the requirements of §123.31. The application shall include the following information:
(a) A statement that the Tribe is recognized by the Secretary of the Interior;
(b) A descriptive statement demonstrating that the Tribal governing body is currently carrying out substantial governmental duties and powers over a defined area. This statement should:
(1) Describe the form of the Tribal government;
(2) Describe the types of governmental functions currently performed by the Tribal governing body, such as, but not limited to, the exercise of police powers affecting (or relating to) the health, safety, and welfare of the affected population; taxation; and the exercise of the power of eminent domain; and
(3) Identify the source of the Tribal government's authority to carry out the governmental functions currently being performed.
(c) A map or legal description of the area over which the Indian Tribe asserts authority under section 518(e)(2) of the Act; a statement by the Tribal Attorney General (or equivalent official authorized to represent the Tribe in all legal matters in court pertaining to the program for which it seeks approval) which describes the basis for the Tribe's assertion (including the nature or subject matter of the asserted regulatory authority); copies of those documents such as Tribal constitutions, by-laws, charters, executive orders, codes, ordinances, and/or resolutions which support the Tribe believes are relevant to its assertion under section 518(e)(2) of the Act; and a description of the location of the surface waters for which the Tribe proposes to establish an NPDES permit program.
(d) A narrative statement describing the capability of the Indian Tribe to administer an effective, environmentally sound NPDES permit program. The statement should include:
(1) A description of the Indian Tribe's previous management experience which may include the administration of programs and service authorized by the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450 et seq.), the Indian Mineral Development Act (25 U.S.C. 2101 et seq.), or the Indian Sanitation Facility Construction Activity Act (42 U.S.C. 2004a);
(2) A list of existing environmental or public health programs administered by the Tribal governing body, and a copy of related Tribal laws, regulations, and policies;
(3) A description of the entity (or entities) which exercise the executive, legislative, and judicial functions of the Tribal government;
(4) A description of the existing, or proposed, agency of the Indian Tribe which will assume primary responsibility for establishing and administering an NPDES permit program (including a description of the relationship between the existing or proposed agency and its regulated entities);
(5) A description of the technical and administrative abilities of the staff to administer and manage an effective, environmentally sound NPDES permit program or a plan which proposes how the Tribe will acquire additional administrative and technical expertise. The plan must address how the Tribe will obtain the funds to acquire the administrative and technical expertise.
(e) The Regional Administrator may, at his or her discretion, request further documentation necessary to support a Tribe's eligibility.
(f) If the Administrator or his or her delegatee has previously determined that a Tribe has met the prerequisites that make it eligible to assume a role similar to that of a state as provided by statute under the Safe Drinking Water Act, the Clean Water Act, or the Clean Air Act, then that Tribe need provide only that information unique to the NPDES program which is requested by the Regional Administrator.
[58 FR 67982, Dec. 22, 1993, as amended at 59 FR 64343, Dec. 14, 1994]

§123.33   Procedures for processing an Indian Tribe's application.
(a) The Regional Administrator shall process an application of an Indian Tribe submitted pursuant to §123.32 in a timely manner. He shall promptly notify the Indian Tribe of receipt of the application.
(b) The Regional Administrator shall follow the procedures described in 40 CFR part 123, subpart D in processing a Tribe's request to assume the NPDES program.
[58 FR 67982, Dec. 22, 1993, as amended at 59 FR 64343, Dec. 14, 1994]

§123.34   Provisions for Tribal criminal enforcement authority.
To the extent that an Indian Tribe is precluded from asserting criminal enforcement authority as required under §123.27, the Federal Government will exercise primary criminal enforcement responsibility. The Tribe, with the EPA Region, shall develop a procedure by which the Tribal agency will refer potential criminal violations to the Regional Administrator, as agreed to by the parties, in an appropriate and timely manner. This procedure shall encompass all circumstances in which the Tribe is incapable of exercising the enforcement requirements of §123.27. This agreement shall be incorporated into a joint or separate Memorandum of Agreement with the EPA Region, as appropriate.
[58 FR 67983, Dec. 22, 1993]

Title 40: Protection of Environment
PART 131 -- WATER QUALITY STANDARDS
Subpart A -- General Provisions
*   *   *   *   *
§131.4   State authority.
    (a) States (as defined in §131.3) are responsible for reviewing, establishing, and revising water quality standards. As recognized by section 510 of the Clean Water Act, States may develop water quality standards more stringent than required by this regulation. Consistent with section 101(g) and 518(a) of the Clean Water Act, water quality standards shall not be construed to supersede or abrogate rights to quantities of water.
    (b) States (as defined in §131.3) may issue certifications pursuant to the requirements of Clean Water Act section 401. Revisions adopted by States shall be applicable for use in issuing State certifications consistent with the provisions of §131.21(c).
    (c) Where EPA determines that a Tribe is eligible to the same extent as a State for purposes of water quality standards, the Tribe likewise is eligible to the same extent as a State for purposes of certifications conducted under Clean Water Act section 401.
[56 FR 64893, Dec. 12, 1991, as amended at 59 FR 64344, Dec. 14, 1994]
*   *   *   *   *
§131.8   Requirements for Indian Tribes to administer a water quality standards program.
(a) The Regional Administrator, as determined based on OMB Circular A-105, may accept and approve a tribal application for purposes of administering a water quality standards program if the Tribe meets the following criteria:
(1) The Indian Tribe is recognized by the Secretary of the Interior and meets the definitions in §131.3 (k) and (l),
(2) The Indian Tribe has a governing body carrying out substantial governmental duties and powers,
(3) The water quality standards program to be administered by the Indian Tribe pertains to the management and protection of water resources which are within the borders of the Indian reservation and held by the Indian Tribe, within the borders of the Indian reservation and held by the United States in trust for Indians, within the borders of the Indian reservation and held by a member of the Indian Tribe if such property interest is subject to a trust restriction on alienation, or otherwise within the borders of the Indian reservation, and
(4) The Indian Tribe is reasonably expected to be capable, in the Regional Administrator's judgment, of carrying out the functions of an effective water quality standards program in a manner consistent with the terms and purposes of the Act and applicable regulations.
(b) Requests by Indian Tribes for administration of a water quality standards program should be submitted to the lead EPA Regional Administrator. The application shall include the following information:
(1) A statement that the Tribe is recognized by the Secretary of the Interior.
(2) A descriptive statement demonstrating that the Tribal governing body is currently carrying out substantial governmental duties and powers over a defined area. The statement should:
(i) Describe the form of the Tribal government;
(ii) Describe the types of governmental functions currently performed by the Tribal governing body such as, but not limited to, the exercise of police powers affecting (or relating to) the health, safety, and welfare of the affected population, taxation, and the exercise of the power of eminent domain; and
(iii) Identify the source of the Tribal government's authority to carry out the governmental functions currently being performed.
(3) A descriptive statement of the Indian Tribe's authority to regulate water quality. The statement should include:
(i) A map or legal description of the area over which the Indian Tribe asserts authority to regulate surface water quality;
(ii) A statement by the Tribe's legal counsel (or equivalent official) which describes the basis for the Tribes assertion of authority and which may include a copy of documents such as Tribal constitutions, by-laws, charters, executive orders, codes, ordinances, and/or resolutions which support the Tribe's assertion of authority; and
(iii) An identification of the surface waters for which the Tribe proposes to establish water quality standards.
(4) A narrative statement describing the capability of the Indian Tribe to administer an effective water quality standards program. The narrative statement should include:
(i) A description of the Indian Tribe's previous management experience which may include the administration of programs and services authorized by the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450 et seq.), the Indian Mineral Development Act (25 U.S.C. 2101 et seq.), or the Indian Sanitation Facility Construction Activity Act (42 U.S.C. 2004a);
(ii) A list of existing environmental or public health programs administered by the Tribal governing body and copies of related Tribal laws, policies, and regulations;
(iii) A description of the entity (or entities) which exercise the executive, legislative, and judicial functions of the Tribal government;
(iv) A description of the existing, or proposed, agency of the Indian Tribe which will assume primary responsibility for establishing, reviewing, implementing and revising water quality standards;
(v) A description of the technical and administrative capabilities of the staff to administer and manage an effective water quality standards program or a plan which proposes how the Tribe will acquire additional administrative and technical expertise. The plan must address how the Tribe will obtain the funds to acquire the administrative and technical expertise.
(5) Additional documentation required by the Regional Administrator which, in the judgment of the Regional Administrator, is necessary to support a Tribal application.
(6) Where the Tribe has previously qualified for eligibility or "treatment as a state" under a Clean Water Act or Safe Drinking Water Act program, the Tribe need only provide the required information which has not been submitted in a previous application.
(c) Procedure for processing an Indian Tribe's application. (1) The Regional Administrator shall process an application of an Indian Tribe submitted pursuant to §131.8(b) in a timely manner. He shall promptly notify the Indian Tribe of receipt of the application.
(2) Within 30 days after receipt of the Indian Tribe's application the Regional Administrator shall provide appropriate notice. Notice shall:
(i) Include information on the substance and basis of the Tribe's assertion of authority to regulate the quality of reservation waters; and
(ii) Be provided to all appropriate governmental entities.
(3) The Regional Administrator shall provide 30 days for comments to be submitted on the Tribal application. Comments shall be limited to the Tribe's assertion of authority.
(4) If a Tribe's asserted authority is subject to a competing or conflicting claim, the Regional Administrator, after due consideration, and in consideration of other comments received, shall determine whether the Tribe has adequately demonstrated that it meets the requirements of §131.8(a)(3).
(5) Where the Regional Administrator determines that a Tribe meets the requirements of this section, he shall promptly provide written notification to the Indian Tribe that the Tribe is authorized to administer the Water Quality Standards program.
[56 FR 64895, Dec. 12, 1991, as amended at 59 FR 64344, Dec. 14, 1994]

Title 40: Protection of Environment
PART 233 -- 404 STATE PROGRAM REGULATIONS
Subpart G -- Eligible Indian Tribes
*   *   *   *   *
§233.60   Requirements for eligibility.
    Section 518(e) of the CWA, 33 U.S.C. 1378(e), authorizes the Administrator to treat an Indian Tribe as eligible to apply for the 404 permit program under section 404(g)(1) if it meets the following criteria:
    (a) The Indian Tribe is recognized by the Secretary of the Interior.
    (b) The Indian Tribe has a governing body carrying out substantial governmental duties and powers.
    (c) The functions to be exercised by the Indian Tribe pertain to the management and protection of water resources which are held by an Indian Tribe, held by the Untied States in trust for the Indians, held by a member of an Indian Tribe if such property interest is subject to a trust restriction an alienation, or otherwise within the borders of the Indian reservation.
    (d) The Indian Tribe is reasonably expected to be capable, in the Administrator's judgment, of carrying out the functions to be exercised, in a manner consistent with the terms and purposes of the Act and applicable regulations, of an effective section 404 dredge and fill permit program.
[58 FR 8183, Feb. 11, 1993, as amended at 59 FR 64345, Dec. 14, 1994]

§233.61   Determination of Tribal eligibility.
An Indian Tribe may apply to the Regional Administrator for a determination that it meets the statutory criteria which authorize EPA to treat the Tribe in a manner similar to that in which it treats a State, for purposes of the section 404 program. The application shall be concise and describe how the Indian Tribe will meet each of the requirements of §233.60. The application should include the following information:
(a) A statement that the Tribe is recognized by the Secretary of the Interior.
(b) A descriptive statement demonstrating that the Tribal governing body is currently carrying out substantial governmental duties and powers over a defined area. This Statement should:
(1) Describe the form of the Tribal government.
(2) Describe the types of governmental functions currently performed by the Tribal governing body, such as, but not limited to, the exercise of police powers affecting (or relating to) the health, safety, and welfare of the affected population; taxation; and the exercise of the power of eminent domain; and
(3) Identify the source of the Tribal government's authority to carry out the governmental functions currently being performed.
(c)(1) A map or legal description of the area over which the Indian Tribe asserts regulatory authority pursuant to section 518(e)(2) of the CWA and §233.60(c);
(2) A statement by the Tribal Attorney General (or equivalent official) which describes the basis for the Tribe's assertion under section 518(e)(2) (including the nature or subject matter of the asserted regulatory authority) which may include a copy of documents such as Tribal constitutions, by-laws, charters, executive orders, codes, ordinances, and/or resolutions which support the Tribe's assertion of authority;
(d) A narrative statement describing the capability of the Indian Tribe to administer an effective 404 permit program. The Statement may include:
(1) A description of the Indian Tribe's previous management experience which may include the administration of programs and services authorized by the Indian Self Determination & Education Act (25 U.S.C. 450 et seq.), The Indian Mineral Development Act (25 U.S.C. 2101 et seq.), or the Indian Sanitation Facility Construction Activity Act (42 U.S.C. 2004a).
(2) A list of existing environmental or public health programs administered by the Tribal governing body, and a copy of related Tribal laws, regulations, and policies;
(3) A description of the entity (or entities) which exercise the executive, legislative, and judicial functions of the Tribal government.
(4) A description of the existing, or proposed, agency of the Indian Tribe which will assume primary responsibility for establishing and administering a section 404 dredge and fill permit program or plan which proposes how the Tribe will acquire additional administrative and technical expertise. The plan must address how the Tribe will obtain the funds to acquire the administrative and technical expertise.
(5) A description of the technical and administrative abilities of the staff to administer and manage an effective, environmentally sound 404 dredge and fill permit program.
(e) The Administrator may, at his discretion, request further documentation necessary to support a Tribal application.
(f) If the Administrator has previously determined that a Tribe has met the requirements for eligibility or for "treatment as a State" for programs authorized under the Safe Drinking Water Act or the Clean Water Act, then that Tribe need only provide additional information unique to the particular statute or program for which the Tribe is seeking additional authorization.
(Approved by the Office of Management and Budget under control number 2040-0140)
[58 FR 8183, Feb. 11, 1993, as amended at 59 FR 64345, Dec. 14, 1994]

§233.62   Procedures for processing an Indian Tribe's application.
(a) The Regional Administrator shall process an application of an Indian Tribe submitted pursuant to §233.61 in a timely manner. He shall promptly notify the Indian Tribe of receipt of the application.
(b) The Regional Administrator shall follow the procedures described in §233.15 in processing a Tribe's request to assume the 404 dredge and fill permit program.
[58 FR 8183, Feb. 11, 1993, as amended at 59 FR 64346, Dec. 14, 1994]

Title 40: Protection of Environment
PART 501 -- STATE SLUDGE MANAGEMENT PROGRAM REGULATIONS
Subpart B -- Development and Submission of State Programs
*   *   *   *   *
§501.22   Requirements for eligibility of Indian Tribes.
    (a) Consistent with section 518(e) of the CWA, 33 U.S.C. 1377(e), the Regional Administrator will treat an Indian Tribe as eligible to apply for sludge management program authority if it meets the following criteria:
    (1) The Indian Tribe is recognized by the Secretary of the Interior.
    (2) The Indian Tribe has a governing body carrying out substantial governmental duties and powers.
    (3) The functions to be exercised by the Indian Tribe pertain to the management and protection of water resources which are held by an Indian Tribe, held by the United States in trust for the Indians, held by a member of an Indian Tribe if such property interest is subject to a trust restriction on alienation, or otherwise within the borders of an Indian reservation.
    (4) The Indian Tribe is reasonably expected to be capable, in the Regional Administrator's judgment, of carrying out the functions to be exercised, in a manner consistent with the terms and purposes of the Act and applicable regulations, of an effective sludge management program.
    (b) An Indian Tribe which the Regional Administrator determines meets the criteria described in paragraph (a) of this section must also satisfy the State program requirements described in this part for assumption of the State program.
[58 FR 67984, Dec. 22, 1993, as amended at 59 FR 64346, Dec. 14, 1994]

§501.23   Request by an Indian Tribe for a determination of eligibility.
An Indian Tribe may apply to the Regional Administrator for a determination that it qualifies pursuant to section 518 of the Act for purposes of seeking sludge management program approval. The application shall be concise and describe how the Indian Tribe will meet each of the requirements of §501.22. The application shall include the following information:
(a) A statement that the Tribe is recognized by the Secretary of the Interior;
(b) A descriptive statement demonstrating that the Tribal governing body is currently carrying out substantial governmental duties and powers over a defined area. This statement should:
(1) Describe the form of the Tribal government;
(2) Describe the types of governmental functions currently performed by the Tribal governing body, such as, but not limited to, the exercise of police powers affecting (or relating to) the health, safety, and welfare of the affected population; taxation; and the exercise of the power of eminent domain; and
(3) Identify the source of the Tribal government's authority to carry out the governmental functions currently being performed.
(c) A map or legal description of the area over which the Indian Tribe asserts authority under section 518(e)(2) of the Act; a statement by the Tribal Attorney General (or equivalent official authorized to represent the Tribe in all legal matters in court pertaining to the program for which it seeks approval) which describes the basis for the Tribe's assertion (including the nature or subject matter of the asserted regulatory authority); copies of those documents such as Tribal constitutions, by-laws, charters, executive orders, codes, ordinances, and/or resolutions which the Tribe believes are relevant to its assertion under section 518(e)(2) of the Act.
(d) A narrative statement describing the capability of the Indian Tribe to administer an effective, environmentally sound sludge management program. The statement should include:
(1) A description of the Indian Tribe's previous management experience which may include the administration of programs and service authorized by the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450 et seq.), the Indian Mineral Development Act (25 U.S.C. 2101 et seq.), or the Indian Sanitation Facility Construction Activity Act (42 U.S.C. 2004a);
(2) A list of existing environmental or public health programs administered by the Tribal governing body, and a copy of related Tribal laws, regulations, and policies;
(3) A description of the entity (or entities) which exercise the executive, legislative, and judicial functions of the Tribal government;
(4) A description of the existing, or proposed, agency of the Indian Tribe which will assume primary responsibility for establishing and administering a sludge management program (including a description of the relationship between the existing or proposed agency and its regulated entities);
(5) A description of the technical and administrative abilities of the staff to administer and manage an effective, environmentally sound sludge management program or a plan which proposes how the Tribe will acquire additional administrative and technical expertise. The plan must address how the Tribe will obtain the funds to acquire the administrative and technical expertise.
(e) The Regional Administrator may, at his discretion, request further documentation necessary to support a Tribe's eligibility.
(f) If the Administrator or her delegatee has previously determined that a Tribe has met the prerequisites that make it eligible to assume a role similar to that of a state as provided by statute under the Safe Drinking Water Act, the Clean Water Act, or the Clean Air Act, then that Tribe need provide only that information unique to the sludge management program which is requested by the Regional Administrator.
[58 FR 67984, Dec. 22, 1993, as amended at 59 FR 64346, Dec. 14, 1994]

§501.24   Procedures for processing an Indian Tribe's application.
(a) The Regional Administrator shall process an application of an Indian Tribe submitted pursuant to §501.23 in a timely manner. He shall promptly notify the Indian Tribe of receipt of the application.
(b) The Regional Administrator shall follow the procedures described in subpart C of this part in processing a Tribe's request to assume the sludge management program.
[58 FR 67985, Dec. 22, 1993, as amended at 59 FR 64346, Dec. 14, 1994]

§501.25   Provisions for Tribal criminal enforcement authority.
To the extent that an Indian Tribe is precluded from asserting criminal enforcement authority as required under §§501.1(c)(5) and 501.17, the Federal Government will exercise primary criminal enforcement responsibility. The Tribe, with the EPA Region, shall develop a procedure by which the Tribal agency will refer potential criminal violations to the Regional Administrator, as agreed to by the parties, in an appropriate and timely manner. This procedure shall encompass all circumstances in which the Tribe is incapable of exercising the enforcement requirements of §§501.1(c)(5) and 501.17. This agreement shall be incorporated into a joint or separate Memorandum of Agreement with the EPA Region, as appropriate.
[58 FR 67985, Dec. 22, 1993]


[Federal Register: September 17, 2009 (Volume 74, Number 179)]
[Notices]
[Page 47804-47805]
[DOCID:fr17se09-48]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0408]

Draft Guidance for Industry on Microbiological Data for Systemic
Antibacterial Drug Products--Development, Analysis, and Presentation;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled
``Microbiological Data for Systemic Antibacterial Drug Products--
Development, Analysis, and Presentation.'' The draft guidance informs
industry of FDA's current thinking regarding the types of
microbiological studies, assessments, and clinical trials needed to
support an investigational new drug application (IND) and a new drug
application (NDA) for a systemic antibacterial drug product.
Recommendations in this guidance cover microbiological considerations
in the three major areas of conducting general nonclinical studies;
conducting animal and human studies and clinical trials; and
establishing and updating in vitro susceptibility test methods, quality
control (QC) parameters, and interpretive criteria. This guidance also
recommends the content and format for presentation of microbiological
data for antibacterial drug products in the Microbiology subsection of
labeling.

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 written or electronic comments on the draft guidance
by December 16, 2009.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT:  Fred Marsik, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6108, Silver Spring, MD 20993-0002, 301-
796-7956; or
    Edward Cox, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6212, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Microbiological Data for Systemic Antibacterial Drug
Products--Development, Analysis, and Presentation.'' This guidance
provides recommendations on the type of information to provide in
submissions to the clinical microbiology section of INDs and NDAs for
systemic antibacterial drug products. The in vitro microbiological data
and in vivo animal studies (e.g., spectrum of activity in vitro and in
appropriate animal models of human disease) support the justification
of testing in humans. Sponsors usually submit data from nonclinical
investigations to provide proof of concept of clinical activity before
commencing human phase 2 studies and clinical trials and to aid in the
development of provisional interpretive criteria for use in phase 3
clinical trials. Microbiological data submitted to an NDA will be used
to substantiate the microbiological information contained in the
labeling.
    Specific topics discussed in the guidance include validating in
vitro susceptibility testing methods; mechanism of action studies;
mechanism of resistance studies; use of animal models; clinical trial
protocols; establishment of QC parameters and interpretive criteria;
submission and placement of microbiology information in the NDA
submission; format and content of the Microbiology subsection of the
labeling; and revision of existing susceptibility testing methods, QC
parameters, or interpretive criteria.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on the
microbiological data for systemic antibacterial drug products. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance 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).
    (1) The draft guidance provides recommendations on the type of
information to include in submissions of the clinical microbiology
section of INDs and NDAs for systemic antibacterial drug products. The
microbiology section of an NDA is required under 21 CFR 314.50(d)(4)
and this information collection is approved under OMB Control Number
0910-0001. For INDs, this information is required under 21 CFR
312.23(a) and approved under OMB Control Number 0910-0014.
    (2) The draft guidance also recommends the types of data that
should be submitted in a labeling supplement to update the microbiology
information in approved labeling if an application holder chooses to
update this information without relying on a standard recognized by
FDA. The submission of labeling supplements is required under 21 CFR
314.70(b)(2)(v) and 201.56(a)(2) and this information collection is
approved under OMB Control Numbers 0910-0001 and 0910-0572,
respectively.
    (3) Appendix A of the draft guidance describes the content of the
Microbiology subsection of labeling. This labeling is covered under 21
CFR 201.57(c)(13)(i) and the information collection is approved under
OMB Control Number 0910-0572.
    (4) The draft guidance also references the guidance for industry
entitled ``Updating Labeling for Susceptibility Test Information in
Systemic Antibacterial Drug Products and Antimicrobial Susceptibility
Testing Devices'' for updating labeling information. The information
collection in this guidance has been approved under OMB Control Number
0910-0638.

III. Comments

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

IV. 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: September 10, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-22380 Filed 9-16-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: September 30, 2010 (Volume 75, Number 189)]
[Notices]
[Page 60488-60490]
[DOCID:fr30se10-118]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62993, File No. SR-MSRB-2010-06]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Order Granting Approval of Proposed Rule Change, as Modified by
Amendment No. 1 Thereto, To Establish a Subscription To the Information
Collected by the MSRB's Short-Term Obligation Rate Transparency
(``SHORT'') System

September 24, 2010.

I. Introduction

    On August 10, 2010, the Municipal Securities Rulemaking Board
(``MSRB''), filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities

Exchange Act of 1934 (``Exchange Act''),\1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to establish a subscription to
the information collected by the MSRB's Short-term Obligation Rate
Transparency (``SHORT'') System. The proposed rule change was published
for comment in the Federal Register on August 23, 2010.\3\ The
Commission received no comment letters about the proposed rule change.
On September 16, 2010, the MSRB filed with the Commission, pursuant to
Section 19(b)(1) of the Exchange Act \4\ and Rule 19b-4 thereunder,\5\
Amendment No. 1 to the proposed rule change.\6\ This order approves the
proposed rule change as modified by Amendment No. 1.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 62734 (August 17,
2010), 75 FR 51864 (the ``original proposed rule change'').
    \4\ 15 U.S.C. 78s(b)(1).
    \5\ 17 CFR 240.19b-4.
    \6\ In Amendment No. 1, the MSRB partially amends the text of
the original proposed rule change to correct a typographical error
in the definition of the data element Liquidity Facility Type. In
all other respects, the original proposed rule change remains as
originally filed. This is a technical amendment and is not subject
to notice and comment.
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change, As Modified by Amendment
No. 1 to the Proposed Rule Change

    The SHORT System is a facility of the MSRB for the collection and
dissemination of information about securities bearing interest at
short-term rates. Currently, these securities consist of Auction Rate
Securities (``ARS'') and Variable Rate Demand Obligations (``VRDOs'').
The proposed rule change consists of a proposal to establish a
subscription to the information collected by the SHORT System. The data
stream subscription would be provided through a Web service and would
be made available for an annual fee of $10,000.\7\
---------------------------------------------------------------------------

    \7\ The proposed subscription price would cover a portion of the
administrative, technical and operating costs of the SHORT
subscription service but would not cover all costs of such
subscription service or of the SHORT System. The MSRB has proposed
establishing the subscription price at a commercially reasonable
level.
---------------------------------------------------------------------------

    Information disseminated from the SHORT System also is posted to
the MSRB's Electronic Municipal Market Access (EMMA) Web portal
pursuant to the EMMA short-term obligation rate transparency service.
Such information would be made available to subscribers simultaneously
with the availability of such information to the EMMA Web portal. The
subscription service would make the information collected by the SHORT
System available to market participants for re-dissemination and for
use in creating value-added products and services. Such re-
dissemination and third-party use would provide market participants,
including investors and the general public, additional avenues for
obtaining the information collected by the SHORT System and would make
additional tools available for making well-informed investment
decisions.
    Data elements with respect to the SHORT subscription service that
would be provided through the data stream would be set forth in the
SHORT System Subscriber Manual posted on the MSRB Web site. The SHORT
System Subscriber Manual would provide a complete, up-to-date listing
of all data elements made available through the SHORT subscription
service, including any additions, deletions or modifications to
disseminated data elements, detailed definitions of each data element,
specific data format information, and information about technical data
elements to support transmission and data-integrity processes between
the SHORT System and subscribers.
    Subscriptions would be provided through computer-to-computer data
streams utilizing XML files for data. Appropriate schemas and other
technical specifications for accessing the Web services through which
the data stream will be provided would be set forth in the SHORT System
Subscriber Manual posted on the MSRB Web site.
    The MSRB would make the SHORT subscription service available on an
equal and non-discriminatory basis. Subscribers would be subject to all
of the terms of the subscription agreement to be entered into between
the MSRB and each subscriber, including proprietary rights of third
parties in information provided by such third parties that is made
available through the subscription. The MSRB would not be responsible
for the content of the information submitted by submitters that is
distributed to subscribers of the SHORT subscription service.
    The MSRB has requested that the proposed rule change be made
effective on September 30, 2010.

III. Discussion and Commission Findings

    The Commission has carefully considered the proposed rule change
and finds that the proposed rule change is consistent with the
requirements of the Exchange Act and the rules and regulations
thereunder applicable to the MSRB \8\ and, in particular, the
requirements of Section 15B(b)(2)(C) of the Exchange Act \9\ and the
rules and regulations thereunder. Section 15B(b)(2)(C) of the Exchange
Act requires, among other things, that the MSRB's rules be designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in municipal securities, to remove impediments to and perfect the
mechanism of a free and open market in municipal securities, and, in
general, to protect investors and the public interest.\10\ In
particular, the Commission believes that the SHORT subscription service
would serve as an additional mechanism by which the MSRB works toward
removing impediments to and helping to perfect the mechanisms of a free
and open market in municipal securities. The subscription service would
make the information collected by the SHORT System available to market
participants for re-dissemination and for use in creating value-added
products and services. Such re-dissemination and third-party use would
provide market participants, including investors and the general
public, additional avenues for obtaining the information collected by
the SHORT System and would make additional tools available for making
well-informed investment decisions. Broad access to the information
collected by the SHORT System, in addition to the public access through
the EMMA Web portal, should further assist in preventing fraudulent and
manipulative acts and practices by improving the opportunity for public
investors to access material information about Auction Rate Securities
and Variable Rate Demand Obligations.
---------------------------------------------------------------------------

    \8\ In approving this proposed rule change, the Commission notes
that it has considered the proposed rule's impact on efficiency,
competition and capital formation. 15 U.S.C. 78c(f).
    \9\ 15 U.S.C. 78o 4(b)(2)(C).
    \10\ Id.
---------------------------------------------------------------------------

    Furthermore, broader re-dissemination and third-party use of the
information collected by the SHORT System should promote a more fair
and efficient municipal securities market in which transactions are
effected on the basis of material information available to all parties
to such transactions, which should allow for fairer pricing of
transactions based on a more complete understanding of the terms of the
securities (including any changes thereto).

IV. Conclusion

    For the foregoing reasons, the Commission finds that the proposed
rule change, as amended, is consistent with the Exchange Act and the
rules and regulations thereunder applicable to the MSRB and, in
particular, the requirements of Section 15B(b)(2)(C) of the Exchange
Act \11\ and the rules and regulations thereunder. The proposal will
become effective on September 30, 2010, as requested by the MSRB.
---------------------------------------------------------------------------

    \11\ Id.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Exchange Act,\12\ that the proposed rule change (SR-MSRB-2010-06), as
amended, be, and it hereby is, approved.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-24510 Filed 9-29-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register: August 27, 2007 (Volume 72, Number 165)]
[Rules and Regulations]
[Page 48938-48942]
[DOCID:fr27au07-3]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 65

[EPA-HQ-OAR-2007-0429; FRL-8459-5]
RIN 2060-A045

Revisions to Consolidated Federal Air Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: The EPA is taking direct final action on the General
Provisions for Consolidated Federal Air Rule to allow extensions to the
deadline imposed for source owners and operators to conduct required
performance tests in certain specified force majeure circumstances. On
May 16, 2007, we published a final rule that revised the General
Provisions for Standards of Performance for New Stationary Sources, for
National Emission Standards for Hazardous Air Pollutants, and for
National Emission Standards for Hazardous Air Pollutants for Source
Categories to allow extensions to the deadline imposed for source
owners and operators to conduct required performance tests in certain
specified force majeure circumstances. We recently realized that we
should have also revised the Consolidated Federal Air Rule to allow for
similar extensions.

DATES: This rule is effective on November 26, 2007 without further
notice, unless EPA receives adverse comment by September 26, 2007. If
we receive adverse comment, we will publish a timely withdrawal in the
Federal Register informing the public that some or all of the
amendments in this rule will not take effect.

ADDRESSES: Submit your comments, identified under Docket ID No. EPA-HQ-
OAR-2007-0429 by one of the following methods:
     http://www.regulations.gov. Follow the on-line instructions for

submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Revisions to Consolidated Federal Air Rule,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Avenue, NW., Washington, DC 20460. Please include a total of two
copies.
     Hand Delivery: EPA Docket Center, 1301 Constitution
Avenue, NW., EPA Headquarters Library, Room 3334, EPA West Building,
Washington, DC 20460. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2007-0429. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal

information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site

is an ``anonymous access'' system, which

means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through http://www.regulations.gov, your

e-mail address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. 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. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm    Docket: All documents in the docket are listed in the http://.

http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Revisions to

Consolidated Federal Air Rule Docket, EPA/DC, EPA West Building, EPA
Headquarters Library, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC. The 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 Air Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ms. Lula Melton, Air Quality
Assessment Division (C304-02), Office of Air Quality Planning and
Standards, U.S. Environmental Protection Agency, Research Triangle
Park, North Carolina 27711; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
Table of Contents

I. Why Is EPA Using a Direct Final Rule?
II. Does This Action Apply to Me?
III. Judicial Review
IV. This Action
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    H. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    I. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    J. National Technology Transfer and Advancement Act
    K. Congressional Review Act

I. Why Is EPA Using a Direct Final Rule?

    The EPA is publishing this rule without a prior proposed rule
because we view this as a non-controversial action and anticipate no
adverse comment. The changes mirror those recently promulgated in the
May 16, 2007 final rule revising the General Provisions for Standards
of Performance for New Stationary Sources, for National Emission
Standards for Hazardous Air Pollutants, and for National Emission
Standards for Hazardous Air Pollutants for Source Categories (``Force
Majeure Rule'') which allowed extensions to the deadline imposed for
source owners and operators to conduct required performance tests in
certain specified force majeure circumstances. Nonetheless, in the
``Proposed Rules'' section of this Federal Register, we are publishing
a separate document that will serve as the proposed rule if relevant
adverse comments are received on this direct final rule. We will not
institute a second comment period on this action. Any parties
interested in commenting, must do so at this time. For further
information about commenting on this rule, see the ADDRESSES section of
this document. If EPA receives adverse comment, we will publish a
timely withdrawal in the Federal Register informing the public that
this direct final rule will not take effect. We would address all
public comments in any subsequent final rule based on the proposed
rule.

II. Does This Action Apply to Me?

    This action applies to any owner or operator of a source required
to conduct performance testing to demonstrate compliance with
applicable standards under the General Provisions for Consolidated
Federal Air Rule.

III. Judicial Review

    Under section 307(b)(1) of the Clean Air Act (CAA), judicial review
of this direct final rule is available by filing a petition for review
in the United States Court of Appeals for the District of Columbia
Circuit by October 26, 2007. Only those objections to this final rule
that were raised with reasonable specificity during the period for
public comment may be raised during judicial review. Under section
307(b)(2) of the CAA, the requirements that are the subject of this
direct final rule may not be challenged later in civil or criminal
proceedings brought by EPA to enforce these requirements.

IV. This Action

    The direct final rule allows source owners or operators, in the
event of a force majeure, to petition the Administrator for an
extension of the deadline(s) by which they are required to conduct an
initial or subsequent performance test required by the Consolidated
Federal Air Rule. Performance tests required as a result of enforcement
orders or enforcement actions are not covered by this rule because
enforcement agreements contain their own force majeure provisions. A
``force majeure'' is defined as an event that will be or has been
caused by circumstances beyond the control of the affected facility,
its contractors, or any entity controlled by the affected facility that
prevents the owner or operator from complying with the regulatory
requirement to conduct performance tests within the specified timeframe
despite the affected facility's best efforts to fulfill the obligation.
Examples of such events are acts of nature, acts of war or terrorism,
or equipment failure or safety hazard beyond the control of the
affected facility.
    If an affected owner or operator intends to assert a claim that a
force majeure is about to occur, occurs, or has occurred, the owner or
operator must notify the Administrator, in writing, as soon as
practicable following the date the owner or operator first knew, or
through due diligence should have known, that the event may cause or
caused a delay in testing beyond the regulatory deadline. The owner or
operator must provide a written description of the event and a
rationale for attributing the delay in testing beyond the regulatory
deadline to the force majeure; describe the measures taken or to be
taken to minimize the delay; and identify a date by which the owner or
operator proposes to conduct the performance test. The test must be

conducted as soon as practicable after the force majeure occurs.
    The decision as to whether or not to grant an extension to the
performance test deadline is solely within the discretion of the
Administrator. The Administrator will notify the owner or operator in
writing of approval or disapproval of the request for an extension as
soon as practicable. If an owner or operator misses its performance
test deadline due to a force majeure event, and the request for an
extension is subsequently approved, the owner or operator will not be
held in violation for failure to conduct the performance test within
the prescribed regulatory timeframe.
    We recognize that there may be circumstances beyond a source
owner's or operator's control constituting a force majeure event that
could cause an owner or operator to be unable to conduct performance
tests before the regulatory deadline. We developed this rule to provide
a mechanism for consideration of these force majeure events and
granting of extensions where warranted. Under current rules, a source
owner or operator who is unable to comply with performance testing
requirements within the allotted timeframe due to a force majeure is
regarded as being in violation and subject to enforcement action. As a
matter of policy, EPA often exercises enforcement discretion regarding
such violations. However, where circumstances beyond the control of the
source owner or operator constituting a force majeure prevent the
performance of timely performance tests, we believe that it is
appropriate to provide an opportunity to such owners and operators to
make good faith demonstrations and obtain extensions of the performance
testing deadline where approved by the Administrator in appropriate
circumstances.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 (58 FR 51735 October 4, 1993) and is
therefore not subject to review under the EO.

B. Paperwork Reduction Act

    The information collection requirements in this rule have been
submitted for approval to the Office of Management and Budget (OMB)
under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The
information collection requirements are not enforceable until OMB
approves them.
    The final rule requires a written notification only if a plant
owner or operator needs an extension of a performance test deadline due
to certain rare events, such as acts of nature, acts of war or
terrorism, or equipment failure or safety hazard beyond the control of
the affected facility. Since EPA believes such events will be rare, the
projected cost and hour burden will be minimal.
    The increased annual average reporting burden for this collection
(averaged over the first 3 years of the ICR) is estimated to total 6
labor hours per year at a cost of $377.52. This includes one response
per year from six respondents for an average of 1 hour per response. No
capital/startup costs or operation and maintenance costs are associated
with the final reporting requirements. Burden means the total time,
effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a
Federal agency. This includes the time needed to review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements; train personnel to be able to
respond to a collection of information; search data sources; complete
and review the collection of information; and transmit or otherwise
disclose the information.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9. When this ICR is
approved by OMB, the Agency will publish a technical amendment to 40
CFR part 9 in the Federal Register to display the OMB control number
for the approved information collection requirements contained in this
final rule.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act generally requires an agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedure
Act or any other statute unless the agency certifies that the rule will
not have a significant economic impact on a substantial number of small
entities. Small entities include small businesses, small organizations,
and small governmental jurisdictions.
    For purposes of assessing the impacts of today's final rule on
small entities, small entity is defined as: (1) A small business as
defined by the Small Business Administration's (SBA) regulations at 13
CFR 121.201; (2) a governmental jurisdiction that is a government of a
city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of today's final rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. Extensions
to deadlines for conducting performance tests will provide flexibility
to small entities and reduce the burden on them by providing them an
opportunity for additional time to comply with performance test
deadlines during force majeure events. We expect force majeure events
to be rare since these events include circumstances such as, acts of
nature, acts of war or terrorism, and equipment failure or safety
hazard beyond the control of the affected facility.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and Tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, Local, and Tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes

any regulatory requirements that may significantly or uniquely affect
small governments, including Tribal governments, it must have developed
under section 203 of the UMRA a small government agency plan. The plan
must provide for notifying potentially affected small governments,
enabling officials of affected small governments to have meaningful and
timely input in the development of EPA regulatory proposals with
significant Federal intergovernmental mandates, and informing,
educating, and advising small governments on compliance with the
regulatory requirements.
    EPA has determined that the final rule does not contain a Federal
mandate that may result in expenditures of $100 million or more for
State, local, and Tribal governments, in the aggregate, or the private
sector in any one year. The maximum total annual cost of this final
rule for any year has been estimated to be less than $435. Thus,
today's final rule is not subject to the requirements of Sections 202
and 205 of the UMRA.
    EPA has determined that the final rule contains no regulatory
requirements that might significantly or uniquely affect small
governments. The final rule requires source owners and operators to
provide a written notification to the Agency only if an extension to a
performance test deadline is necessary due to rare force majeure
events. Therefore, the final rule is not subject to the requirements of
section 203 of the UMRA.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
(meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
    This direct final rule does not have federalism implications. It
will not have substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132. The final rule
requirements will not supercede State regulations that are more
stringent. In addition, the final rule requires a written notification
only if a plant owner or operator needs an extension of a performance
test deadline due to certain rare events, such as acts of nature, acts
of war or terrorism, or equipment failure or safety hazard beyond the
control of the affected facility. Since EPA believes such events will
be rare, the projected cost and hour burden will be minimal. Thus,
Executive Order 13132 does not apply to this rule.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This direct final rule does
not have tribal implications as specified in Executive Order 13175.
This final rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    Executive Order 13045 ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that: (1) Is determined to be ``economically significant''
as defined under Executive Order 12866, and (2) concerns an
environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
    This direct final rule is not subject to the Executive Order
because it is not economically significant as defined in Executive
Order 12866 and because the Agency does not have reason to believe the
environmental health or safety risks addressed by this action present a
disproportionate risk to children. This rule does not affect the
underlying control requirements established by the applicable standards
but only the timeframe associated with performance testing in limited
circumstances.

H. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order (59 FR 7629, February 16, 1994) establishes federal
executive policy on environmental justice. Its main provision directs
federal agencies, to the greatest extent practicable and permitted by
law, to make environmental justice part of their mission by identifying
and addressing, as appropriate, disproportionately high and adverse
human health or environmental effects of their programs, policies, and
activities on minority populations and low-income populations in the
United States.
    EPA has determined that this direct final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. This direct final rule does not relax the control
requirements on affected sources. It merely allows an extension to the
deadline for conducting performance tests in rare force majeure
circumstances.

I. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a
significant regulatory action under Executive Order 12866.

J. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note), directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards. New
test methods are not being proposed in

this rulemaking, but EPA is allowing for extensions of the regulatory
deadlines by which owners or operators are required to conduct
performance tests when a force majeure is about to occur, occurs, or
has occurred which prevents owners or operators from testing within the
regulatory deadline. Therefore, NTTAA does not apply.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective on November 26, 2007.

List of Subjects in 40 CFR Part 65

    Air pollution control, Environmental protection, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Dated: August 17, 2007.
Stephen L. Johnson,
Administrator.

0
For the reasons stated in the preamble, title 40, chapter I, part 65 of
the Code of Federal Regulations are amended as follows:

PART 65--[AMENDED]

0
1. The authority citation for part 65 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart A--[Amended]

0
2. Section 65.2 is amended by adding, in alphabetical order, a
definition for ``Force majeure'' to read as follows:

Sec.  65.2  Definitions.

* * * * *
    Force majeure means, for purposes of Sec.  65.157, an event that
will be or has been caused by circumstances beyond the control of the
affected facility, its contractors, or any entity controlled by the
affected facility that prevents the owner or operator from complying
with the regulatory requirement to conduct performance tests within the
specified timeframe despite the affected facility's best efforts to
fulfill the obligation. Examples of such events are acts of nature,
acts of war or terrorism, or equipment failure or safety hazard beyond
the control of the affected facility.
* * * * *

0
3. Section 65.157 is amended as follows:
0
a. By revising paragraph (c) introductory text.
0
b. By adding paragraphs (c)(1)(viii) through (c)(1)(xi).

Sec.  65.157  Performance test and flare compliance determinations.

* * * * *
    (c) Except as specified in paragraphs (c)(1)(viii), (c)(1)(ix),
(c)(1)(x), and (c)(1)(xi) of this section, unless a waiver of
performance testing or flare compliance determination is obtained under
this section or the conditions of another subpart of this part, the
owner or operator shall perform such tests specified in the following:
    (1) * * *
    (viii) If a force majeure is about to occur, occurs, or has
occurred for which the affected owner or operator intends to assert a
claim of force majeure, the owner or operator shall notify the
Administrator, in writing as soon as practicable following the date the
owner or operator first knew, or through due diligence should have
known that the event may cause or caused a delay in testing beyond the
regulatory deadline, but the notification must occur before the
performance test deadline unless the initial force majeure or a
subsequent force majeure event delays the notice, and in such cases,
the notification shall occur as soon as practicable.
    (ix) The owner or operator shall provide to the Administrator a
written description of the force majeure event and a rationale for
attributing the delay in testing beyond the regulatory deadline to the
force majeure; describe the measures taken or to be taken to minimize
the delay; and identify a date by which the owner or operator proposes
to conduct the performance test. The performance test shall be
conducted as soon as practicable after the force majeure occurs.
    (x) The decision as to whether or not to grant an extension to the
performance test deadline is solely within the discretion of the
Administrator. The Administrator will notify the owner or operator in
writing of approval or disapproval of the request for an extension as
soon as practicable.
    (xi) Until an extension of the performance test deadline has been
approved by the Administrator under paragraphs (c)(1)(viii),
(c)(1)(ix), and (c)(1)(x) of this section, the owner or operator of the
affected facility remains strictly subject to the requirements of this
part.
* * * * *
[FR Doc. E7-16840 Filed 8-24-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 143 (Tuesday, July 26, 2011)]
[Notices]
[Pages 44582-44583]
[FR Doc No: 2011-18835]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-SFUND-2004-0006; FRL-9443-3]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Community Right-to-Know Reporting Requirements Under
Sections 311 and 312 of the Emergency Planning and Community Right-to-
Know Act (EPCRA) (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the

nature of the information collection and its estimated burden and cost.

DATES: Additional comments may be submitted on or before August 25,
2011.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-
SFUND-2004-0006, to (1) EPA online using http://www.regulations.gov
(our preferred method), by e-mail to<EMAIL_ADDRESS>or by
mail to: EPA Docket Center, Environmental Protection Agency, Superfund
Docket, Environmental Protection Agency, Mailcode: 28221T, 1200
Pennsylvania Ave., NW., Washington, DC 20460 and (2) OMB by mail to:
Office of Information and Regulatory Affairs, Office of Management and
Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Sicy Jacob, Office of Emergency
Management, 5104A, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On February 14, 2011 (76 FR 8363), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received one comment during the
comment period, which is addressed in the ICR. Any additional comments
on this ICR should be submitted to EPA and OMB within 30 days of this
notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-SFUND-2004-0006, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Superfund
Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The EPA/DC 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 Reading Room is 202-566-
1744, and the telephone number for the Superfund Docket is 202-566-
0276.
    Use EPA's electronic docket and comment system at http://www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, confidential business information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://www.regulations.gov.
    Title: Community Right-to-Know Reporting Requirements under
Sections 311 and 312 of the Emergency Planning and Community Right-to-
Know Act (EPCRA) (Renewal).
    ICR number: EPA ICR No. 1352.12, OMB Control No. 2050-0072.
    ICR Status: This ICR is scheduled to expire on July 31, 2011. Under
OMB regulations, the Agency may continue to conduct or sponsor the
collection of information while this submission is pending at OMB. An
Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR Part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR Part 9.
    Abstract: The authority for these requirements is sections 311 and
312 of the Emergency Planning and Community Right-to-Know Act (EPCRA),
1986 (42 U.S.C. 11011, 11012). EPCRA Section 311 requires owners and
operators of facilities subject to OSHA Hazard Communication Standard
to submit a list of chemicals or Material Safety Data Sheet (MSDS) (for
those chemicals that exceed thresholds, specified in 40 CFR part 370)
to the State Emergency Response Commission (SERC), Local Emergency
Planning Committee (LEPC) and the local fire department (LFD) with
jurisdiction over their facility. This is a one-time requirement unless
a new facility becomes subject to the regulations or updating the
information by facilities that are already covered by the regulations.
EPCRA Section 312 requires owners and operators of facilities subject
to OSHA HCS to submit an inventory form (for those chemicals that
exceed the thresholds, specified in 40 CFR Part 370) to the SERC, LEPC,
and LFD with jurisdiction over their facility. This form is to be
submitted on March 1 of each year, on the inventory of chemicals in the
previous calendar year.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 10
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Facilities required to prepare or
have available a material safety data sheet for any hazardous chemical
under the OSHA Hazard Communication Standard.
    Estimated Number of Respondents: 390,000 private facilities and
3,552 state and local agencies.
    Frequency of Response: Annual.
    Estimated Total Annual Hour Burden: 3,909,132.
    Estimated Total Annual Cost: $247,574,394, includes $6,389,900
annualized capital and operation & maintenance (O&M) cost.
    Changes in the Estimates: There is an increase of 116,700 hours in
the total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This increase is due to the increase in the
number of respondents.

    Dated: July 20, 2011.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2011-18835 Filed 7-25-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 60 (Wednesday, March 28, 2018)]
[Rules and Regulations]
[Page 13183]
[FR Doc No: 2018-06164]

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

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

The Code of Federal Regulations is sold by the Superintendent of Documents.

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

Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 /
Rules and Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1140

[Docket No. FDA-2018-N-0011]

Cigarettes, Smokeless Tobacco, and Covered Tobacco Products;
Change of Office Name and Address; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is amending
its Cigarettes, Smokeless Tobacco, and Covered Tobacco Products
regulations to reflect a change of office name and mailing address for
the Center for Tobacco Products' (CTP's) Office of Compliance and
Enforcement. This action is editorial in nature and is intended to
improve the accuracy of the Agency's regulations.

DATES: This rule is effective March 28, 2018.

FOR FURTHER INFORMATION CONTACT: May Nelson, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993, 1-877-
CTP-1373, [email protected].

SUPPLEMENTARY INFORMATION: FDA is amending our regulations in part 1140
(21 CFR part 1140) to reflect the change of an office name and the
mailing address in the regulation. The office name was the Office of
Compliance and the new office name is Office of Compliance and
Enforcement. The mailing address for notices submitted under Sec.
1140.30(a)(2) is updated to CTP's Document Control Center, 10903 New
Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993.
    Publication of this document constitutes final action under the
Administrative Procedure Act (5 U.S.C. 553). FDA has determined that
notice and public comment are unnecessary because the amendments to the
regulations provide only technical changes to correct an office name
and address, and are nonsubstantive. To the extent that 5 U.S.C. 553(d)
applies, FDA has determined that, for the same reasons, good cause
exists for making this rule effective upon publication in the Federal
Register.

List of Subjects in 21 CFR Part 1140

    Advertising, Labeling, Smoking, Tobacco.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
1140 is amended as follows:

PART 1140--CIGARETTES, SMOKELESS TOBACCO, AND COVERED TOBACCO
PRODUCTS

0
1. The authority citation for part 1140 continues to read as follows:

    Authority:  21 U.S.C. 301 et seq., Sec. 102, Pub. L. 111-31, 123
Stat. 1776.

0
2. Amend Sec.  1140.30 by revising the last sentence of paragraph
(a)(2) to read as follows:

Sec.  1140.30   Scope of permissible forms of labeling and advertising.

    (a) * * *
    (2) * * * The manufacturer, distributor, or retailer shall send
this notice to the Office of Compliance and Enforcement, Center for
Tobacco Products, Food and Drug Administration, Document Control
Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD
20993.
* * * * *

    Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06164 Filed 3-27-18; 8:45 am]
 BILLING CODE 4164-01-P