[Federal Register: June 2, 2008 (Volume 73, Number 106)]
[Rules and Regulations]
[Page 31358-31360]
[DOCID:fr02jn08-5]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. FDA-2008-N-0148]

Medical Devices; Hearing Aids; Technical Data Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations governing hearing aid labeling to reference the most recent
version of the consensus standard used to determine the technical data
to be included in labeling for hearing aids. We are amending the
regulations to require that manufacturers may use state-of-the-art
methods to provide technical data in hearing aid labeling. FDA is also
amending the regulations to update an address and remove an outdated
requirement. FDA is amending the regulations in accordance with its
direct final rule procedures. Elsewhere in this issue of the Federal
Register, we are publishing a companion proposed rule under FDA's usual
procedures for notice and comment rulemaking to provide a procedural
framework to finalize the rule in the event we receive a significant
adverse comment and withdraw this direct final rule.

DATES: This rule is effective October 15, 2008. The Director of the
Office of the Federal Register approves the incorporation by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain
publications in Sec.  801.420(c)(4) (21 CFR 801.420(c)(4)) as of
October 15, 2008. Submit written or electronic comments by August 18,
2008. If we receive no significant adverse comments within the
specified comment period, we intend to publish a document confirming
the effective date of the final rule in the Federal Register within 30
days after the comment period on this direct final rule ends. If we
receive any timely significant adverse comment, we will withdraw this
final rule in part or in whole by publication of a document in the
Federal Register within 30 days after the comment period ends.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0148, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described previously, in
the ADDRESSES portion of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and Docket No. for this rulemaking. All comments received may be posted
without change to  http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to  http://www.regulations.gov and insert the
docket number(s), 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.

FOR FURTHER INFORMATION CONTACT: Eric A. Mann, Center for Devices and
Radiological Health (HFZ-460), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. What Is the Background of the Rulemaking?

    In the Federal Register of February 15, 1977 (the 1977 final rule)
(42 FR 9286), FDA published a final rule establishing requirements for
professional and patient labeling of hearing aids and governing
conditions for sale of hearing aids (Sec.  801.420 and Sec.  801.421
(21 CFR 801.421)). The regulations became effective on August 15, 1977.
Section 801.421(b)(1) of the current regulations provides that, before
the sale of a hearing aid to a prospective user, a hearing aid
dispenser is to provide the prospective user with a copy of the User
Instructional Brochure. Current Sec.  801.420(c)(4) requires that
technical data useful in selecting, fitting, and checking the
performance of a hearing aid be provided in the brochure or in separate
labeling that accompanies the device. The 1977 final rule further
required that the technical data values provided in the brochure or
other labeling be determined according to the test procedures
established by the Acoustical Society of America (ASA) in the American
National Standard ``Specification of Hearing Aid Characteristics,''
ANSI S3.22-1976 (ASA 70-1976), which was incorporated by reference in
the regulation.
    ANSI S3.22 (ASA 70-1976) established measurement methods and
specifications for several important hearing aid characteristics. The
standard provided a method of ascertaining whether a hearing aid, after
being manufactured and shipped, met the specifications and design
parameters stated by the manufacturer for a particular model, within
the tolerance stated by the standard.
    In 1982, ASA revised the standard (ANSI S3.22-1982) (ASA 70-1982).
In a final rule published in the Federal Register of July 24, 1985 (50
FR 30153), FDA incorporated the revised standard into Sec.
801.420(c)(4). ASA revised the standard again in 1987 (ANSI S3.22-1987)
(ASA 70-1987). In a final rule published in the Federal Register of
December 21, 1989 (54 FR 52395), FDA incorporated the revised standard
into Sec.  801.420(c)(4). In 1996, ASA revised the standard again (ANSI
S3.22-1996) (ASA 70-1996). In a final rule published in the Federal
Register of November 3, 1999 (64 FR 59618), FDA incorporated the
revised standard into Sec.  801.420(c)(4).

    In 2003, ASA revised the standard again (ANSI S3.22-2003). The 1996
version of the standard was written prior to the development of digital
hearing aids. Therefore, some of the test procedures described in the
1996 version of the standard, designed for assessment of analogue
hearing aids, were modified to accommodate digital technology. The
major differences between the two versions of the standard are as
follows:
     In the 1996 standard, the gain control was set to a
specific reference test position for automatic gain control (AGC)
hearing aids and for all other types of hearing aids. In the 2003
standard, AGC hearing aids are tested in AGC mode only for those tests
associated with AGC functions and are operated in non-AGC mode for all
other tests.
     In the 2003 standard, the tolerance for setting the gain
control to reference test setting (RTS) has been widened to  1.5 dB from  1.0 dB.
    FDA is now incorporating the 2003 standard into Sec.
801.420(c)(4). This will allow hearing aid manufacturers to use the up-
to-date methods to determine the technical data values for hearing
aids.

II. What Does This Direct Final Rulemaking Do?

    In this direct final rule, FDA is:
     Amending Sec.  801.420(c)(4) to change the identification
of the standard from ``American National Standard `Specification of
Hearing Aid Characteristics,' ANSI S3.22-1996 (ASA 70-1996) (Revision
of ANSI S3.22-1987)'' to ``American National Standard `Specification of
Hearing Aid Characteristics,' ANSI S3.22-2003 (Revision of ANSI S3.22-
1996) (Includes April 2007 Erratum)''. FDA also is updating an address
in this section, changing ``1350 Piccard Dr., rm. 240,'' to ``1350
Piccard Dr., rm. 150,''.
     Removing Sec.  801.420(d). This section requires that
manufacturers submit to FDA for review their User Instructional
Brochure and other labeling for each type of hearing aid on or before
August 15, 1977. This section was included with the initial hearing aid
rule in 1977. It was intended to provide for an initial FDA review of
the labeling to meet the new requirements. This section is outdated and
is no longer necessary.

III. What Are the Procedures for Issuing a Direct Final Rule?

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA
announced the availability of the guidance document entitled ``Guidance
for FDA and Industry: Direct Final Rule Procedures'' that described
when and how FDA will employ direct final rulemaking. We believe that
this rule is appropriate for direct final rulemaking because it is
intended to make noncontroversial changes to existing regulations. We
anticipate no significant adverse comment.
    Consistent with FDA's procedures on direct final rulemaking,
elsewhere in this issue of the Federal Register, we are publishing a
companion proposed rule that is identical to this direct final rule.
The companion proposed rule provides a procedural framework within
which the rule may be finalized in the event the direct final rule is
withdrawn because of any significant adverse comment. The comment
period for this direct final rule runs concurrently with the comment
period of the companion proposed rule. Any comments received in
response to the companion proposed rule will also be considered as
comments regarding this direct final rule.
    If we receive any significant adverse comment, we intend to
withdraw this final rule before its effective date by publication of a
notice in the Federal Register within 30 days after the comment period
ends. A significant adverse comment is defined as a comment that
explains why the rule would be inappropriate, including challenges to
the rule's underlying premise or approach, or would be ineffective or
unacceptable without change. In determining whether an adverse comment
is significant and warrants terminating a direct final rulemaking, we
will consider whether the comment raises an issue serious enough to
warrant a substantive response in a notice-and-comment process in
accordance with section 553 of the Administrative Procedure Act (APA)
(5 U.S.C. 553). Comments that are frivolous, insubstantial, or outside
the scope of the rule will not be considered significant or adverse
under this procedure. For example, a comment recommending an additional
change to the rule will not be considered a significant adverse
comment, unless the comment states why the rule would be ineffective
without the additional change. In addition, if a significant adverse
comment applies to part of a rule and that part can be severed from the
remainder of the rule, we may adopt as final those parts of the rule
that are not the subject of a significant adverse comment.
    If we withdraw the direct final rule, all comments received will be
considered under the companion proposed rule in developing a final rule
under the usual notice-and-comment procedures under the APA (5 U.S.C.
552a et seq.). If we receive no significant adverse comment during the
specified comment period, we intend to publish a confirmation document
in the Federal Register within 30 days after the comment period ends.

IV. What is the Legal Authority for This Direct Final Rule?

    This direct final rule is authorized by sections 201, 301, 501,
502, 701, and 704 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321, 331, 351, 352, 371, and 374).

V. What is the Environmental Impact of This Direct Final Rule?

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

VI. What is the Economic Impact of This Direct Final Rule?

    FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this direct final rule is not a significant regulatory action as
defined by the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The direct final rule amends the existing hearing
aid regulation to refer to the updated consensus standard that is used
to determine the technical data in hearing aid labeling. It does not
impose any new requirements. Communications from manufacturers to FDA
show that they are prepared to comply with this standard immediately.
The agency, therefore, certifies that the direct final rule will not
have a significant economic impact on a substantial number of small
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that

includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
direct final rule to result in any 1-year expenditure that would meet
or exceed this amount.

VII. How Does the Paperwork Reduction Act of 1995 Apply to This Direct
Final Rule?

    This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
The collections of information addressed in the direct final rule have
been approved by OMB in accordance with the PRA under the regulations
governing labeling of medical devices (21 CFR part 801, OMB control
number 0910-0485).

VIII. What are the Federalism Impacts of This Direct Final Rule?

    FDA has analyzed this direct final rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the rule does not contain policies that have substantial direct effects
on the States, on the relationship between the National Government and
the States, or on the distribution of power and responsibilities among
the various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

IX. How Do You Submit Comments on This Direct Final Rule?

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this direct
final rule. 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.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.

List of Subjects in 21 CFR Part 801

    Incorporation by reference, Labeling, Medical devices, Reporting
and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
801 is amended as follows:

PART 801--LABELING

0
1. The authority citation for 21 CFR part 801 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.

0
2. Section 801.420 is amended by revising the second and third
sentences of and adding a new fourth sentence to paragraph (c)(4)
introductory text and by removing paragraph (d) to read as follows:

Sec.  801.420  Hearing aid devices; professional and patient labeling.

* * * * *
    (c) * * *
    (4) * * * The determination of technical data values for the
hearing aid labeling shall be conducted in accordance with the test
procedures of the American National Standard ``Specification of Hearing
Aid Characteristics,'' ANSI S3.22-2003 (Revision of ANSI S3.22-1996)
(Includes April 2007 Erratum). The Director of the Office of the
Federal Register approves this incorporation by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the
Standards Secretariat of the Acoustical Society of America, 120 Wall
St., New York, NY 10005-3993, or are available for inspection at the
Regulations Staff, CDRH (HFZ-215), FDA, 1350 Piccard Dr., rm. 150,
Rockville, MD 20850, or at the National Archives and Records
Administration (NARA). * * *
* * * * *

    Dated: May 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-11910 Filed 5-30-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: September 22, 2010 (Volume 75, Number 183)]
[Notices]
[Page 57763]
[DOCID:fr22se10-55]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER10-1777-000]

Sundevil Power Holdings, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

September 14, 2010.
    This is a supplemental notice in the above-referenced proceeding of
Sundevil Power Holdings, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 4, 2010.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-23615 Filed 9-21-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: May 14, 2010 (Volume 75, Number 93)]
[Notices]
[Page 27338-27339]
[DOCID:fr14my10-72]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER10-912-000; ER10-913-000; ER10-914-000]

NASDAQ OMX Commodities Clearing--Contract Merchant LLC; NASDAQ
OMX Commodities Clearing--Delivery LLC; NASDAQ OMX Commodities
Clearing--Finance LLC; Notice of Filing

May 6, 2010.
    Take notice that, on May 3, 2010, NASDAQ OMX Commodities Clearing--
Contract Merchant LLC, NASDAQ OMX Commodities Clearing--Delivery LLC,
and NASDAQ OMX Commodities Clearing--Finance LLC filed a supplement to
its filing in the above captioned docket with information required
under the Commission's regulations. Such filing served to reset the
filing date in this proceeding.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Comment Date: 5 p.m. Eastern Time on May 24, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-11524 Filed 5-13-10; 8:45 am]
BILLING CODE 6717-01-P


                         SUPPORTING STATEMENT FOR THE
               RENEWABLE FUELS STANDARD (RFS2) PROGRAM (RENEWAL)

A.	JUSTIFICATION

1.	Identification of the Information Collection

	1(a)	Title:  Renewable Fuels Standard (RFS2) Program, EPA ICR No. 2380.02, OMB Control Number 2060-0637.

	1(b) 	Short characterization:

	The Energy Policy Act (EPAct) of 2005 amended the Clean Air Act, section 211(o), and required the existing RFS program.  The existing RFS program is referred to in this supporting statement as "RFS1". The RFS1 program started in 2006 and was covered by EPA ICR No. 2242.02, OMB Control Number 2060-0600 is now discontinued.  With the new requirements in the RFS program now RFS2, all supporting information and notices will be addressed under EPA ICR No. 2380.02, OMB Control Number 2060-0637.  Please refer to "Regulation of Fuels and Fuel Additives: Renewable Fuel Standard Program  -  Notice of Proposed Rulemaking" and "Regulation of Fuels and Fuel Additives: Renewable Fuel Standard Program  -  Final Rule" (both available in docket number EPA-HQ-OAR-2005-0161) for a detailed discussion of the RFS1 program.

	The Energy Independence and Security Act of 2007 (EISA) further amended the Clean Air Act, section 211(o), and required new regulations for renewable fuels.  The newer RFS program is referred to in this supporting statement as "RFS2."  Under RFS2, the volume requirement and types of renewable fuels are expanded; non-road uses are included (RFS1 only affected motor vehicle fuel); there are additional types of waivers and special provisions for renewable fuel types; and EPA has implemented an EPA Moderated Transaction System (EMTS) for RINs.  Additional parties will be required to register, keep records, and report.  Please refer to the Final Rule (available in docket number EPA-HQ-OAR-2005-0161) for a detailed discussion of the RFS2 program.

      This supporting statement provides tables that break down reporting items by party (e.g. producer, importer, refiner, etc.) and the cost related to their reporting activity. For compliance purposes, under RFS2, volumes of renewable fuel are identified through the use of renewable identification numbers (RINs) that are initially generated by the producer of the renewable fuel.  However, there are additional types of RINs and the volume of RINs traded is expected to be great.

2.  Need For, and Use of, the Collection

	2(a)	Authority for the Collection

	Sections 114 and 208 of the Clean Air Act (CAA), 42 U.S.C. §§ 7414 and 7542, authorize EPA to require recordkeeping and reporting regarding enforcement of the provisions of Title II of the CAA.

	2(b) 	Practical Utility/Uses of the Data

	The recordkeeping and reporting requirements of this regulation will allow EPA to monitor compliance with the RFS program.

3.  Non-duplication, Consultation, and other Collection Criteria

	3(a) 	Non-duplication

	Efforts have been made to eliminate duplication in this information collection. The information collected is considered CBI and unique to the closed DCFUEL database.  EPA has provided instructions in PDF in which the parties submit data in the Unified Report Form (XLS) to the Agency's Central Data Exchange (CDX). CDX also allows for updating and corrections to individual accounts. The data relates to individual fuel volume by facility and are not available from other sources.

	3(b) 	Public Notice

EPA sought comment on reporting requirements via the Federal Register on November 20, 2012 (77 FR 69620).  EPA received no public comments.

 	3(c)	Consultations

	EPA has consulted with two parties, Mr. Tim Hogan of the American Fuel and Petrochemical Manufactures, who can be contacted on<PHONE_NUMBER>, and Mr. Bob Schafer of The National Biodiesel Board (NBB), who can be reached on<PHONE_NUMBER>. Mr. Schafer did not respond.  Mr. Tim Hogan reviewed the ICR as it relates to the obligated parties and found that the tables were not clear. Changes were made for better analysis of party burden.

	3(d)	Effects of Less Frequent Data Collection

	We have designed the reporting schedule to coincide with existing reporting deadlines applicable to many of the same parties under such programs as RFG (Reformulated Gasoline) and anti-dumping and diesel fuel.  Less frequent collection of data would make it impossible to carry out the provisions of the CAA and EISA.

	3(e)	General Guidelines

	This rule does not exceed any of the OMB guidelines.

      3(f)	Confidentiality

	We inform respondents that they may assert claims of business confidentiality (CBI) for information they submit. Actual RINs should not be treated as confidential business information under RFS2, as they are necessary identifiers to accompany renewable fuels.  Any information claimed as confidential will be treated in accordance with 40 CFR Part 2 and established Agency procedures.  Information that is received without a claim of confidentiality may be made available to the public without further notice to the submitter under 40 CFR § 2.203.

      3(g) 	Sensitive Information

	This information collection does not require submission of any sensitive information.

4.	The Respondents and the Information Requested

	4(a)  	Respondents with NAICS/ SIC Codes

      The respondents to this information collection fall into the following general industry categories:  petroleum refineries (324110/2911), ethyl alcohol manufacturers (325193/2869), other basic organic chemical manufacturing (325110/2869), chemical and allied products merchant wholesalers (426990/5169), petroleum bulk stations and terminals (422710/5171), petroleum and petroleum products merchant wholesalers (422720/5172), and other fuel dealers (454319/5989).

      Using the terminology associated with the RFS2 Rule, we have assumed the following classes of party, which are covered by this supporting statement.

 Producers of renewable fuels
 Importers
 Obligated Parties
 Parties who own RINs (including foreign RIN owners)

      4(b)	Information Requested

      The respondents are subject to this collection to demonstrate compliance with the RFS Program. For this purpose, the respondents are required to report to EPA, via the Agency's Central Data Exchange (CDX), their fuel volumes identified through the use of renewable identification numbers (RINs). The respondents are involved in the initial generation of renewable fuel to be introduced in commerce.  Additional requested information to be reported come from producers and importers in the form of attest engagements reports and new pathway petition submissions.

      	(i)	Data Items

      Record Retention for this collection is five years from the date the records were created. Records related to RIN transactions are to be kept five years from the transaction date. Records can be keep either electronically or on paper.  On request by EPA records must be made available; for electronic records, this includes equipment or software needed to read the electronic records.  If requested by EPA, electronic records shall be converted to paper documents. The types of records for retention under this collection are as follows:

Recordkeeping: Common Requirements for All Parties

   oo Product Transfer Documents (PTDs) for any Activity as a Transferor/Transferee of ownership of Renewable Fuel
   oo Copies of Reports Submitted to EPA records related to RIN Transactions
   oo List of RINS Owned, Purchased, Sold, or Retired
   oo Parties Involved in Each Transaction  -  Transferor, Transferee, and any Broker or Agent
   oo Transaction Date
   oo Additional Information Related to Details of the Transaction and its Terms
   oo Any Parties Other Than Renewable Producers and Obligated Parties
   oo Obligated Parties should retain PTDs associated with transactions

Recordkeeping: Renewable Producer/Importer Specifics  - 1

   oo Records Related to the Generation and Assignment of RINs by Facility
   oo Batch Volume, Batch No., RIN, Renewable Type, Production/Import Date, Lab Results, Additional info related to RIN Generation
   oo Records Related to the Production/Importation of Neat Motor Fuel and its Use
   oo Renewable Fuel Designated by the Producer or Importer of Motor Vehicle Fuel

Recordkeeping: Renewable Producer/Importer Specifics  -  2, Verifiable Records

   oo The amount and type of fossil fuel and waste material-derived fuel used in producing on-site thermal energy dedicated to the production of ethanol at plants producing cellulosic biomass ethanol through the displacement of 90 percent or more of the fossil fuel normally used in the production of ethanol
   oo The amount and type of feedstocks used in producing cellulosic biomass ethanol
   oo The equivalent amount of fossil fuel (based on reasonable estimates) associated with the use of off-site generated waste heat that is used in the production of ethanol at plants producing cellulosic biomass ethanol through the displacement of 90 percent or more of the fossil fuel normally used in the production of ethanol
   oo The  plot plan and process flow diagram for plants producing cellulosic biomass and waste derived ethanol
   oo The independent third party verification required under 40 CFR § 80.1155 for producers cellulosic biomass ethanol and waste derived ethanol

Recordkeeping: Obligated Parties & Renewable Exporters

   oo Records Related to the Use of RINS (by Facility if Applicable) for Compliance
   oo Methods and Variables Used to Calculate the RVO
   oo List of RINs Used to Demonstrate Compliance
   oo Additional Information Related to Details of RIN Use for compliance

      	(ii)	Respondent Activities

      All respondents must be registered in the DCFUEL application to obtain a valid company number to sign up in CDX.  In CDX parties will submit facility registration corrections and updates and report fuel volumes used for buying and selling RINS in the EMTS.  The information submitted to EPA during a company's initial registration defines its roles, responsibilities and participation in the EMTS environment. Producers and importers are responsible for financing a yearly attest engagement or audit to verify their facilities.  In this collection producers and importers may also submit new pathway petitions for EPA approval.

5.  	The Information Collected - Agency Activities, Collection Methodology, and 	Information Management

	5(a)	Agency Activities

   oo All reports and registrations will be reviewed by EPA for completeness and for potential violations.
   oo Potential violations will be referred to enforcement personnel.
   oo Registration numbers will be issued for new registrants.
   oo Contacting reporting parties if there is a problem with their submission.

	5(b)	Collection and Methodology and Management

EPA will to continue to receive all reports, registrations, initial registrations and updates. We anticipate receiving data in a simplified and secure fashion via the Agency's electronic Central Data Exchange (CDX).  Information claimed as CBI will be stored in appropriately controlled areas. EPA will provide Guidance Documents, Report Instructions and Report Templates on http://www.epa.gov/otaq/regs/fuels/forms.htm.

	5(c)	Small Entity Flexibility Provisions

The flexibility provisions that are available to small entities are found in 40 CFR § 80.1441 and § 80.1442.  These refiners have less than 1,500 employees corporate-wide and corporate average crude oil capacity less than or equal to 155,000 barrels per calendar day.  There are only six refiners that meet this definition and are registered in DCFUEL under the RFS2 program.

	5(d)	Collection Schedule

	Registrations are received on a rolling basis.  Updates may be sent in at any time after initial registration.  New parties may enter the regulated industry at any time, triggering registration requirements.   Petitions for new renewable fuels and pathways are also being received.

6.	Estimating the Burden and Cost of Collection

	6(a)	Estimating the Respondent Burden

We drew upon experience implementing similar regulations among the same entities to develop estimates of the burden associated with this collection.  The following assumptions were made in estimating the burden to this collection.  The number in each participating party class were a result of facilities and RIN owner registered in the RFS program in CDX. An estimated percentage of each party total was used to assume how many would submit registration corrections and updates and to see how many new party class registrations and CDX users to expect each year. Producers and importers are required to finance and to submit to EPA an yearly attest engagement.  In the last information request, respondents were required to re-register which increased the cost and hourly burden. From the estimates there are 1192 participants in this collection.

 Producers of renewable fuels (300)
 Importers (72)
 Obligated Parties (150)
 Parties who own RINs (including foreign RIN owners) (950)

      6(b)	Estimating the Respondent Costs

	Three labor categories are involved:  managerial (includes legal and professional review), technical, and clerical. The estimates used the Bureau of Labor Statistics figures from "National Industry-Specific Occupational Employment & Wage Estimate "Petroleum and Coal Products Manufacturing" (May 2011), with a 3% annual inflation factor applied to bring the values to the present.  Using this method, the following wages and benefits apply by category:

Wages and Benefits

Managerial    		$67.44   per hour
Technical		$65.56  per hour
Clerical		$22.17  per hour

Doubling for company overhead beyond wages and benefits, and for convenience, rounding up to the dollar, gives the following rates for this ICR:

Total Employer Cost

Managerial		$135.00 per hour
Technical		$131.00 per hour
Clerical		$   44.00 per hour

It is assumed that for each hour of activity the mix will be about 0.1 hour managerial, 0.7 hour technical, and 0.2 hour clerical.  This gives an average labor cost of $103 per hour, which will be used in this ICR. For purchased services related to attest engagements and some items of registration, we have doubled this hourly cost to $206 in order to more accurately reflect the cost of a certified public accountant (CPA) or licensed professional engineer's (PE) services.  There is no capitol or O&M cost associated with this collection.  There is only respondent hourly burden cost incurred.

                Information Collection Burden by Type of Party
                     Table I:  Producers of Renewable Fuel
                              Collection Activity
                             Number of Respondents
                         Number of Responses per Party
                           Total Number of Responses
                           Time per Response (hours)
                          Cost per Response (dollars)
                                  Total Hours
                             Total Cost (dollars)
80.1416

New renewable fuels pathways at $103/hour
                                      15
                                       1
                                      15
                                       8
                                     $824
                                      120
                                    $12,360
80.1450

(b)(2) Yearly attest engagements at $206/hour
                                      500
                                       1
                                      500
                                      24
                                    $4,944
                                     12000
                                  $2,472,000
(d) Registration updates at $103/hour
                                      125
                                       1
                                      125
                                       2
                                     $206
                                      250
                                    $25,750
New Registrations at $103/hour
                                      25
                                       1
                                      25
                                       2
                                     $206
                                      50
                                    $5,150
New CDX Registrations at $103/hour
                                      25
                                       1
                                      25
                                       2
                                     $206
                                      50
                                    $5,150
TOTALS
                                      690

                                      690

                                     12470
                                  $2,520,410

Assumptions:

500 registered renewable fuel producers

25% registration updates and corrections

3% new pathway petitions by producers of renewable fuels

5% new renewable fuels producers registrations

5% new CDX registrations by renewable fuel producers

                Information Collection Burden by Type of Party
                    Table II:  Importers of Renewable Fuels
Collection Activity
                             Number of Respondents
                         Number of Responses per Party
                           Total Number of Responses
                           Time per Response (hours)
                          Cost per Response (dollars)
                                  Total Hours
                             Total Cost (dollars)
80.1450

(b)(1) New Registration at $103/hour
                                       4
                                       1
                                       4
                                       8
                                     $824
                                      32
                                    $3,296
(b)(2) Yearly Attest Engagement at $206/hour
                                      75
                                       1
                                      75
                                      24
                                    $4,944
                                     1800
                                   $370,800
(d) Registration update and Corrections at $103/hour
                                      19
                                       1
                                      19
                                       2
                                     $206
                                      38
                                    $3,914
New CDX Registration at $103/hour
                                       4
                                       1
                                       4
                                       2
                                     $206
                                       8
                                     $824
TOTALS
                                      102

                                      102

                                     1878
                                   $378,834

Assumptions:

75 registered importers of renewable fuel

25% registration updates and corrections

5% new registrations for importers of renewable fuels

5% new CDX registrations by importers of renewable fuels

                Information Collection Burden by Type of Party
Table III - "Obligated Parties" (Including Refiners and Exporters or Renewable Fuels)
Collection Activity
                             Number of Respondents
                         Number of Responses per Party
                           Total Number of Responses
                           Time per Response (hours)
                          Cost per Response (dollars)
                                  Total Hours
                             Total Cost (dollars)
80.1450

(a) New registrations at $103/hour
                                       8
                                       1
                                       8
                                       8
                                     $824
                                      64
                                    $6,592
(d) registration updates and corrections at $103/hour
                                      38
                                       1
                                      38
                                       8
                                     $824
                                      304
                                    $31,312
New CDX Registrations at $103/hour
                                      15
                                       1
                                      15
                                       2
                                     $206
                                      30
                                    $3,090
TOTALS
                                      61

                                      61

                                      398
                                    40,994

Assumptions:

150 companies registered as obligated parties

25% registration updates and corrections

5% new obligated party registrations

10% new CDX registrations by obligated parties

                Information Collection Burden by Type of Party
Table IV - Any Party Who Owns/Intends to Own RINS (including blenders, brokers, marketers, etc.) (RIN Owners)
Collection Activity
                             Number of Respondents
                         Number of Responses per Party
                           Total Number of Responses
                           Time per Response (hours)
                          Cost per Response (dollars)
                                  Total Hours
                             Total Cost (dollars)
80.1450

(d) Registration updates and corrections at $103/hour
                                      238
                                       1
                                      238
                                       2
                                     $206
                                      476
                                    $49,028
(e) New registrations at $103/hour
                                      48
                                       1
                                      48
                                       8
                                     $824
                                      384
                                    $39,552
New CDX Registrations at $103/hour
                                      48
                                       1
                                      48
                                       2
                                     $206
                                      96
                                    $9,888
TOTALS
                                      334

                                      334

                                      956
                                    $98,468
Assumptions:

950 registered RIN owners

25% registration updates and corrections

5% new RIN owner registration applications

5% new CDX registrations by RIN owners

                Information Collection Burden by Type of Party
         Table V- Additional Items of Reporting for Foreign RIN Owners
Collection Activity
                               Number of Parties
                         Number of Responses per Party
                           Total Number of Responses
                           Time per Response (hours)
                          Cost per Response (dollars)
                                  Total Hours
                                  Total Cost
                                   (dollars)
80.1467

New Applications submitted to be a foreign RIN owner at $103/hour
                                       1
                                       1
                                       1
                                       1
                                     $103
                                       1
                                     $103
Registration Corrections and updates at $103/hour
                                       3
                                       1
                                       3
                                       1
                                     $103
                                       3
                                     $309
New CDX Registrations at $103/hour
                                       1
                                       1
                                       1
                                       1
                                     $103
                                       1
                                     $103
TOTAL
                                       5

                                       5

                                       5
                                     $515

Assumptions:

10 Foreign RIN Owners in party

10% new foreign RIN owner applications

30% updates and corrections in Registration in CDX

	(c)  	Estimating the Agency Burden and Cost

	EPA must generate company and facility registration number(s) for new registrants and notify them of these numbers, which must appear on reports. Report formats and instructions/guidance must be prepared by Agency personnel.  Reports will be processed by contractors and must be reviewed by Agency personnel.  Reporting parties must be contacted if there is a problem with their submission. We have developed forms for RFS2 reporting to include four types, rather than one type, of RIN unlike the RFS1 templates. We have provided RFS2 reporting templates as an attachment to this document.

      This supporting statement considers all Agency costs associated with accepting new registrants and new reports associated with RFS2, as expressed in EPA ICR Number 2333.02. Using the RFS1, and the RFG and anti-dumping ICR, and other recent fuels-related ICRs as a guide in developing these initial estimates for RFS, we anticipate that RFS2 may require the equivalent labor of one full time GS-13 technical employees for a total of $115,000, and labor costs of $54,875 in the clerical category and $19,438 in the management category.  Since we are using the CDX, some costs incurred by the Agency will be tied to the number of registrants who send us reports.  Specifically, there is an annual "subscription cost" associated with the use of CDX that is passed on to the EPA program office and we estimate that registrants due to RFS2 will cost our office approximately $200,000 per year in 2013, 2015 and 2015.  We anticipate $266,666 in annual contract costs related to registration and reporting activities.  We anticipate IT development and testing costs at $ 600,000 divided by three years to yield an annual cost of $200,000.  Adding the following values results in an annual estimated Agency burden as follows:

      One GS-13 technical employee (full time) = 		$   115,000
      One GS-7 clerical worker (full-time) 	 = 	      	       54,875
      One GS-15 manager (1/8 time) 	 = 		       19,438
      Annual CDX subscription fee = 			     200,000
      Annual contract costs = 				     266,666
      Testing and development= 				     200,000
      TOTAL = 						   $855,979

        As with all items in this supporting statement, we strongly encourage comment on the estimated Agency burden and on the Agency activities associated with this proposed information collection.

	(d)	Estimating the Respondent Universe

	We were able to estimate the number of regulated entities drawing upon experience regulating the same or similar entities.

	(e)	Bottom Line Burden Hours and Costs

	From the tables, we estimate the following annual totals:

TOTAL NO. OF RESPONDENTS:     1192
TOTAL NO. OF RESPONSES:	     1192
TOTAL BURDEN HOURS:    	     15,707
TOTAL COST TO RESPONDENTS:  $ 3,039,221

	(f)	Reason for Change in Burden

	There is a sharp decrease of  43,026 hours in the total estimated respondent burden compared to the ICR currently approved by OMB. The total burden hours will decreased from 58,733 to 15,707 and the total number of responses from 7396 to 1192, both notable drops.  This decrease was caused by members in the obligated parties once registered not being required to re-register their companies in this renewal. New registrations are required if a company aquires another or when a new company enters into a party.  The requirements of the current members in the obligated party are to submit updates and corrections to their current registration when needed in CDX.  The number in the respondent universe will decreased in all categories for the obligated parties thus lessoning the reporting burden for its members.

 	6(g)	Burden Statement

	The annual public reporting and recordkeeping burden for this collection of information is estimated to be 13 hours per response (total number of hours divided by total number of responses).  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 are listed in 40 CFR part 9 and 48 CFR chapter 15.

	To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID number EPA-HQ-OAR-2005-0161, which is available for online viewing at www.regulations.gov,or in person viewing at the Air Docket in the EPA Docket Center in Washington, DC (EPA/DC).  The docket is located in the EPA West Building, 1301 Constitution Avenue, NW, Room 3334, and is open from 8:30 a.m. to 4:30 p.m., Eastern Standard Time, Monday through Friday, excluding legal holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Air Docket is<PHONE_NUMBER>.

	An electronic version of the public docket is available at www.regulations.gov.  This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically.  When in the system, select "search," then key in the Docket ID Number identified above.  Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include the EPA Docket ID Number EPA-HQ-OAR-2005-0161 and OMB Control Number 2060-0637 in any correspondence.
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