1This is a major difference from Engle et al. 2004 where either land is purchased to expand operations to cover increased pollution control costs or, if land is too expensive to purchase, production facilities are destroyed to make room for a quiescent zone.

2These costs are well below the $ 90,000 investment cap used in the Engle et al., 2004 study.

1 MEMORANDUM Date: May 12, 2004 To: Renée Johnson, EPA From: Maureen Kaplan, Eastern Research Group, Inc. Subject: CAAP Facilities: Access to Credit and Limits on Borrowing Capacity 1. Introduction EPA received comments on the proposed CAAP regulations pertaining to aquaculturists' difficulty in obtaining access to credit and limits on borrowing capacity given high absolute debt levels at these facilities. Furthermore, commenters state that lenders are typically reluctant to issue loans to implement pollution control measures since pollution control capital costs are considered non productive assets. Finally, EPA received comment that lenders may attach a " risk premium" to a loan for " specialty crops" that effectively raise the interest rate.

Section 2 reviews the range in potential land, capital and operating costs associated with the final aquaculture rule based on August 2003 costs. Section 3 reviews the debt to assets ratios for the in scope, commercial continuous discharge facilities. Section 4 reviews the requirements of typical agricultural lending programs. Section 5 reports USDA's observations on credit accessibility. Section 6 is a summary on specific issues raised by Engle et al. 2004.

2. Incremental Pollution Control Costs Potentially Associated with the Final CAAP Rule The barrier to entry analysis examined the costs for the 95 commercial in scope facilities. Of these, none are anticipated to incur land costs. 1 In the EPA analysis, then, land costs will not interfere with access to credit or affect borrowing capacity.

Of the 95 commercial facilities, approximately 21 receive capital costs. The largest estimated capital cost under Option B is approximately $ 10,000. Only 1.3 facilities incur a cost of this magnitude. All other capital costs are below $ 2,000 per facility. 2 When capital costs are incurred as a result of the rule, they average less than 0.2 percent of existing assets. 2 Under the final rule, incremental O& M costs are estimated to be incurred by 66 of the 95 facilities. This implies that operating loan capacity would be unaffected for roughly one of every three facilities. EPA evaluated the impact on debt capacity for the facilities that incurred costs and found that facilities which were viable prior to the incurrence of additional pollution control costs continued to meet loan repayment qualifications.

3. Debt Assets Ratios 3.1 United States Department of Agriculture ( USDA) Data Table 1 describes the USDA farm typology ( Tables are presented at the end of the memorandum.). Table 2 summarizes the financial performance by farm typology group based on Agricultural Resource Management Survey data ( USDA, 2002). These data represent all farms, not just aquaculture operations. However, debt appears to be concentrated in the larger operations with nearly three out of every ten large facilities (>$ 1,000,000 in annual revenues) having a debt asset ratio greater than 40 percent.

3.2 URI Financial Ratio Data Comerford and Rice ( 2004) presents financial ratios for aquaculture businesses in the Northeast Region. The median balance sheet indicated a debt assets ratio greater than 100 percent, that is, net worth is negative. The businesses that responded to the URI questionnaire are primarily shellfish, a crop that uses a grow out production system not in the scope of the final rule.

3.3 EPA Detailed Questionnaire Data The commercial in scope population is represented by 31 companies. Of these, two did not supply balance sheet data and a third changed ownership and did not supply balance sheet data. Of the remaining companies, 15 have debt asset ratios greater than 40 percent. That is, the EPA data set has a higher proportion of companies with debt asset ratios greater than 40 percent than is seen in the USDA data representing all farms, but a lower proportion than that seen in the URI financial data.

4. Review of Agricultural Lending This section presents the findings of the review of published information on lending institution requirements and summarizes the results of a review of debt burden among farms.

4.1 Market Share of Lenders Stam, et al. ( 2003) examine the USDA data and report on the characteristics of the major lender types. Section 4 of this memorandum draws heavily on their report. Figure 1 summarizes their findings. Commercial banks had nearly 40 percent of the market share of farm operator debt, down from 46.6 percent in 1999 ( Ryan and Koenig, 2001). 3 39.4%

30.3% 20.7% 6.1% 3.5%

Commercial Banks ( 39.4%) Farm Credit System ( 30.3%) Individuals and Others ( 20.7%) Life Insurance Companies ( 6.1%) Farm Service Agency ( 3.5%)

Figure 1. Distribution of Farm Business Debt by Lender, December 31, 2002 The Farm Credit System holds another 30 percent of the debt. The Farm Credit System ( FCS)   is part of the Farm Credit Administration ( FCA), an independent agency in the Executive Branch. Originally created by Executive Order in 1933, Congress authorized the FCA through the Farm Credit Act of 1971 as amended. It is responsible for the regulation and examination of the banks, associations, and related entities that make up the Farm Credit System ( FCS) and the Federal Agricultural Mortgage Corporation ( Farmer Mac) ( FCA, 2004a).

Individuals and others ( a group that contains farmland sellers, merchants, input suppliers, cooperatives, contractors and others) form the third largest holder of such debt. Because the conditions and qualifications required by this third group of lenders is variable and not known at this time, they are not considered further in this analysis.

Life insurance companies account for slightly over 6 percent. ( These data do not include Commodity Credit Corporation crop loans which are estimated at $ 4.2 billion at the end of calendar 2002 [ Stam, et al., 2003, p. 11, footnote 2 to Table 1]).

The smallest lender   the Farm Service Agency ( FSA)   is part of the United States Department of Agriculture ( USDA). The direct lending program of the Farm Service Agency has been declining over the past 15 years and now holds 3.5 percent of the market. 3AgFirst FCB, AgriBank FCB, FCB of Wichita, FCB of Texas, and Western FCB.

4 4.2 Background on Lenders 4.2.1 Agricultural Banks The Federal Reserve System Board of Governors classifies a bank as agricultural if the ratio of farm loans to total loans exceeds the unweighted average of all banks on a given date. In contrast, the Federal Deposit Insurance Corporation criterion is a 25 percent ratio of agricultural loans to all loans. In mid year 2002, USDA reports 2,644 agricultural banks by the Federal Reserve definition and 1,896 by the FDIC definition ( Stam et al., 2003, p. 21).

4.2.2 Farm Credit Administration Farm Credit System The Farm Credit System ( FCS) is a nationwide network of borrower owned lending institutions with the intent to provide domestic agriculture with a source of sound, dependable credit at competitive rates of interest. Because FCA examines each institution for financial soundness and compliance with applicable laws and regulations, membership in FCS might fluctuate over time. Different types of institutions include:

# Farm Credit Banks ( FCBs) formed by the merger of Federal Land Banks and Federal Intermediate Credit Banks in 1988. As of January 2003, there were five FCBs, each of which has a specified lending authorities within a chartered territory. 3 # Agricultural Credit Bank ( ACB) formed by the merger of a Federal Credit Bank and a Bank for Cooperatives. As of 1 January 2001, there was one ACB which has FCBspecified lending authorities within a chartered territory and Bank for Cooperatives lending authorities nationwide ( CoBank).

Many different types of institutions are affiliated with the FCBs and ACB: Agricultural Credit Association ( ACA), Agricultural Credit Bank ( ACB), Federal Land Bank Association ( FLBA), Federal Land Credit Association ( FLCA), Production Credit Associations ( PCAs), and Agricultural Credit Association with PCA and FLCA subsidiaries.

Federal Agricultural Mortgage Corporation The Federal Agricultural Mortgage Corporation (" Farmer Mac") is a stockholder owned for profit corporation created by Congress to establish a secondary market for agricultural real estate mortgages and USDA guaranteed farmer program and rural development loans. Congress authorized Farmer Mac by the Agricultural Credit Act of 1987, created it in 1988, and amended the Act in 1990 to create the Farmer Mac II program at the request of USDA ( USC, 2004). Farmer Mac has never received government funding, but is backed by a $ 1.5 billion line of credit with the U. S. Treasury. By purchasing loans from lenders, Farmer 4FSA emergency loans to cover physical and production losses in declared disaster areas are not considered in this review.

5 Mac enables the lenders to make new loans with the replenished capital. Under " Farmer Mac I," the corporation guarantees mortgage loans secured by first liens on agricultural real estate while under " Farmer Mac II" the corporation guarantees securities backed by portions of farm ownership and farm operating loans, rural business and commodity development loans, and certain other loans guaranteed by USDA ( Farmer Mac, 2004).

4.2.3 Farm Service Agency The USDA's Farm Service Agency ( FSA) operates two types of farm loan programs   ( 1) a guaranteed loan program wherein FSA guarantees up to 95 percent of the principal loan amount made by a conventional agricultural lender and ( 2) a direct loan program. 4 FSA is often known as a " lender of last resort" whose participants are beginning farmers who can't qualify for a conventional loan ( FSA, 2004). The volume of delinquent loan payments has declined every year from 1989 ($ 3.2 billion) to 2001 ($ 333 million). The slight uptick, to $ 446 million is seen for 2002, but this is very similar to the value for 2000. USDA mentions that supplemental aid, disaster insurance, crop insurance subsidies, and the 2002 Farm Act enable farmers to repay their loans ( Stam et al., 2003, p. 12).

4.3 Loan and Loan Guarantee Characteristics Table 3 summarizes characteristics of agricultural loan and loan guarantees. No one identifies the ability to cover 100 percent of the investment; FSA will guarantee up to 95 percent of the loan amount, not the amount of the investment. The United States Code establishes a standard for a guaranteed loan as requiring no less than a 20 percent down payment ( 80 percent loan to value ratio; USC, 2004, § 2279aa 8). The prequalification questions for Farmer Mac requests a 30 percent down payment ( Farmer Mac, 2004).

Title 12, Code of Federal Regulations, § 614.4000 § 614.4050 summarizes loan maturities for long term lending authority by type of institution, see Table 4. The 10 year period used in the CAAP effluent guideline appears well grounded.

4.4 Are There Obstacles to Using Agricultural Loans for " Non productive" Assets?

Table 3 lists some of the purposes to which the loans may be put. Where purposes are identified, they include the construction and repair of buildings and other fixtures used in farm related business. Because water pollution control is associated with, not in lieu of, agricultural production, the effluent guideline is not inconsistent with the intent and purposes of the loans.

The lenders' interest is that the borrower have sufficient cash flow to repay the loan and that, after the loan is in place, the debt to assets ratio not exceed 50 percent. Based on this review of the published information available on the major lenders, EPA's approach appears to be consistent with that used by the lenders to evaluate whether a facility qualifies for a loan. 6 In summary, the review of agricultural lending programs and debt shows that most of the widely used programs such as Farm Credit System, Farm Service Agency, Farmer Mac, and 12 United States Code ( Chapter 23, section 2279aa 8) require at a minimum approximately 20 percent to 30 percent as down payments. Other information from Farmer Mac regarding prequalification information lists a 30 percent down payment ( Farmer Mac, 2004). For the final CAAP rule, this means that nearly all commercial in scope facilities would have to raise less than $ 600 to meet the requirement for the loan.

5. Observations on Credit Accessibility USDA observes that the demand for farm credits increased in 2003 but that the supply remained adequate ( Stam et al., 2003) . In particular,

" Creditworthy farmers are expected to have adequate access to loans, mostly from the largest suppliers   commercial banks, the FCS, and trade credit ( merchants and dealers)." ( p. 2)

Farm lenders are in a stronger financial position with the FSA direct loan portfolio showing $ 1.6 billion in delinquent loans at the end of 2002 compared to $ 8.1 billion in 1990. In addition,

" Farm lenders also learned the risks of lending on the basis of collateral in the 1980s and have instituted better loan analysis tools based on cash flow and other criteria." ( p. 12)

EPA follows USDA methodology in calculating a maximum feasible loan payment and then limiting the test to 80 percent of that value. No adverse impacts were seen as a result of the rule on facilities that were viable before the rule. As noted in Tables 3 and 4, aquatic production qualifies for agricultural loans.

Potential aquaculturists might also apply to a commercial bank for real estate and operating loans. However, aquaculture, per se, is not represented in popular sources of " typical" business financial data such as Risk Management Associates' Annual Statement Studies or Dun & Bradstreet's key business ratios. Comerford and Rice, 2004, marks an initial step in filling this need for the aquaculture industry. Having such data available to banks will assist in making credit more accessible to the industry.

6. Responses to Individual Issues Raised 6.1 High Debt Levels Johnson, 2004 reports a claim that aquaculture facilities would have difficulty obtaining access to credit and limits on borrowing capacity given high absolute debt levels at these facilities. First, while some loans have ceiling limits or limits based on a percentage of the real estate value, none of them mention a limit on absolute debt levels. The requirement is that either a debt asset ratio remain below a certain percentage and/ or that the cash flow is adequate to cover all debt payments and other expenses. EPA uses the USDA basis for calculating the maximum feasible loan payment and found no impacts on viable facilities as a result of the rule. 7 6.2 Reticence to Loan for " Nonproductive Assets"

Section 4.4 and Table 3 document the acceptability of using agricultural loans for soil and water conservation, one form of a " nonproductive asset."

6.3 Risk Premium Johnson, 2004 reports a claims that lenders may attach a " risk premium" to the loan for specialty crops that effectively raises the interest rate. The EPA model uses a real discount rate of 7 percent. Stam et al., 2004 reports nominal 2002 interest rates of 5.0 percent to 7.3 percent for long term loans and 4.5 to 7.2 percent for short and intermediate term loans. Given that inflation for 2002, as measured by CPI, was 2.8 percent, the use of a 7 percent real rate addresses any " risk premium" that might be considered ( CEA, 2004, Table 60).

7. References CEA. 2004. Council of Economic Advisors. Economic Report to the President: 2004. Washington, DC. February.

Comerford, Robert A. and Michael A. Rice. 2004. Northeast Region Aquaculture Business 2003 Financial Benchmark Data. The University of Rhode Island.

Engle et alia. 2004. Carole R. Engle, Steve Pomerleau, Fary Fornshell, Jeffery M. Hinshaw, Debra Sloan, and Skip Thompson. The Economic Impact of Proposed Effluent Treatment Options for Production of Trout Onchorhynchus mykiss in Flow through Tanks. Submitted to USDA. March 2004.

Farmer Mac, 2004. http:// www. farmermac. com/ Non flash/ doc/ bow/ prequalfull. htm.

FCA. 2004a. Farm Credit Administration web site. < http:// www. fca. gov/ About FCA. htm. Downloaded 10 May 2004.

FCA. 2004b. Farm Credit Administration web site. < http:// www. fca. gov/ handbook. nsf/. Downloaded 10 May 2004.

FSA. 2004. Farm Service Agency website. < http:// www. fsa. usda. gov/ dafl/ default. htm> and subsidiary pages. Downloaded 12 May 2001.

Johnson, Renèe. 2004. Memo to record documenting EPA's meeting to discuss an economic analysis of EPA's CAAP regulation on the U. S. trout industry. May 7.

Ryan, James T., and Steven R. Koenig, 2001. " Farm Lender Portfolios and the Financial Condition of Indebted Farm Operators." In: USDA, 2001. Agricultural Income and Finance: Situation and Outlook. AIS 76, February. 8 Stam, Jerome, Daniel Milkove, Steven Koenig, James Ryan, Ted Covey, Robert Hoppe, and Paul Sundell. 2003. Agricultural Income and Finance: Annual Lender Issue. United States Department of Agriculture. Economic Research Service. AIS 80. Washington, DC. March 2003.

USC. 2004. United States Code. Title 12 Banks and Banking. Chapter 23 Farm Credit System. Subchapter VIII Agricultural Mortgage Secondary Market. § 2279aa. < http:// uscode. house. gov/ download/ 12ch23. doc> Downloaded 12 May 2004.

USDA, 2001. United States Department of Agriculture. Economic Research Service. Agricultural Income and Finance: Situation and Outlook Report. AIS 76. Washington, DC. February 2001.

USDA, 2002. United States Department of Agriculture. Economic Research Service. Agricultural Resource Management Survey. Debt/ asset ratios. Http:// www. ers. usda. gov/ data/ farmfinancialmgmt/ GRAPHS/ PDFS/ DARAT_ ALL. pdf and http:// www. ers. usda. gov/ data/ farmfinancialmgmt/ GRAPHS/ PDFS/ DARAT_ SAL. pdf. Downloaded 11 May 2004. 9 Table 1 USDA Farm Typology Main Type Subtype Description Small Family Farms ( Sales less than $ 250,000) Limited resource farms Sales less than $ 100,000; Farm assets less than $ 150,000; Total operator household income less than $ 20,000; Operators may report any major occupation except hired manager.

Retirement farms Small farms whose operators report that they are retired ( excludes limited resource farms whose operators report that they are retired)

Residential/ lifestyle farms Small farms whose operators report a major occupation other than farming ( excludes limited resource farms whose operators report farming as their major occupation)

Low sales farming occupation farms Sales less than $ 100,000; Small farms whose operators report farming as their major occupation ( excludes limited resource farms whose operators report farming as their major occupation)

High sales farming occupation farms Sales between $ 100,000 and $ 249,999; Small farms whose operators report farming as their major occupation ( excludes limited resource farms whose operators report farming as their major occupation)

Large Family Farms Sales between $ 250,000 and $ 499,999.

Very Large Family Farms Sales of $ 500,000 or more.

Nonfamily Farms Farms organized as nonfamily corporations or cooperatives, as well as farms operated by hired managers.

Source: Stam et al., 2003, p. 51. 10 Table 2 Percentage of Farms with Debt Asset Ratios > 40 Percent, By Farm Sales Volume Year $ 100,000 $ 250,000 $ 250,000 $ 500,000 $ 500,000 $ 1,000,000 > $ 1,000,000 All 1996 13.9 23.6 20.4 25.6 9.5 1997 17.1 19.4 24.4 26.5 13.1 1998 14.4 16.7 25.4 29.6 10.7 1999 13.6 15.3 22.0 30.7 9.9 2000 15.6 20.2 24.7 27.8 11.5 2001 14.5 17.8 19.5 30.5 9.5 Sources: USDA, 2002. 11 Table 3 Summary of Loan Requirements Institution Maximum Percent Covered Maximum Amount Term ( yrs) Purpose Other Reference Farmer Mac 80 percent loan to value $ 2,500,000 Agricultural production. Sufficient cash flow USC, 2004 Farmer Mac 70 percent loan to value $ 3,750,000 None specified. Will repay loan with proceeds from agricultural production on property. After loan is in place, market value of total assets will be at least twice total debt. Sufficient cash flow. Farmer Mac,

2004 Farm Credit Administration Real Estate loans up to 75 per cent of appraised property; 97 percent if guaranteed Includes " producers... of aquatic products." FCA, 2004b ( 12 U. S. C. 2017 Section 1. and 12 U. S. C. 2018 Section 1.10)

Farm Service Agency Loan guarantees 95 percent of principal loan amount $ 782,000 up to 40 1 to 7 Purchase farmland, construct or repair buildings and other fixtures, or refinance debt.

Operating loan purposes include land and water development. Farmer must obtain loan from conventional lender and lender arranges for FSA guarantee.

Operating loans typically repaid within 7 years; farm ownership loans cannot exceed 40 years. FSA, 2004 Farm Service Agency Direct Loans $ 200,000 up to 40 1 to 7 Ownership: Purchase farmland, construct/ repair buildings and other fixtures,

soil and water conservation.

Operating: purchase livestock, feed, chemicals;

soil and water conservation. Farmer must be unable to obtain credit elsewhere FSA, 2004 12 Table B 4 Loan Maturities 12 CFR 614. Type of Institution Maturities for Long Term Real Estate Loans 4000( a) Farm Credit Bank 5 to 40 years 4010( a) Agricultural Credit Bank 5 to 40 years 4030( a) Federal Land Credit Assn. 5 to 40 years 4040( a) Production Credit Assn. ( 1) not more than 7 years; ( 2) more than 7 years but not more than 10 years, subject to authorization in policies approved by the funding bank; ( 3) not more than 15 years to producers or harvesters of aquatic products for major capital expenditures...[ emphasis added]

4050( a) Agricultural Credit Assn. 5 to 40 years. Short and intermediate term loans: up to 10 years ( 15 years for aquatic producers and harvesters) [ emphasis added].

Source: 12 CFR 614.


[Federal Register: September 8, 2010 (Volume 75, Number 173)]
[Notices]
[Page 54673-54674]
[DOCID:fr08se10-124]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62827; File No. SR-MSRB-2010-08]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Notice of Filing of Amendments to Rule A-3, on Membership on the
Board To Comply With the Dodd-Frank Wall Street Reform and Consumer
Protection Act

September 1, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 27, 2010, the Municipal Securities Rulemaking Board
(``Board'' or ``MSRB'') filed with the Securities and Exchange
Commission (``SEC'' or ``Commission'') the proposed rule change as
described in Items I and II below, which Items have been prepared by
the MSRB. The MSRB has requested accelerated effectiveness pursuant to
Section 19(b)(2) of the Act.\3\ The Board seeks accelerated
effectiveness of the rule change in order to implement the Board
composition requirements of Section 975 of the Dodd-Frank Wall Street
Reform and Consumer Protection Act, Public Law 111-203, 124 Stat. 1376
(2010) (the ``Dodd-Frank Act''), which has an effective date of October
1, 2010. The rule change must be effective prior to the effective date
of the relevant provision of the Dodd-Frank Act so that the Board may
elect a new Board for the 2011 fiscal year that complies with the Board
composition provisions of the Dodd-Frank Act. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The MSRB is filing with the SEC a proposed rule change consisting
of amendments to Rule A-3, on membership on the Board, in order to
facilitate the change in the composition of the Board to comply with
the Dodd-Frank Act. The MSRB has requested that the proposed rule
change be made effective on an accelerated basis.
    The text of the proposed rule change is available on the MSRB's Web
site at http://www.msrb.org/Rules-and-Interpretations/SEC-Filings/2010-
Filings.aspx and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the MSRB included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Board has prepared summaries, set forth in Section
A, B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to make such changes to
MSRB Rule A-3 as are necessary and appropriate prior to the election of
new Board members for the fiscal year commencing on October 1, 2010
(fiscal year 2011), in order to comply with the Dodd-Frank Act and,
more specifically, those provisions of the Dodd-Frank Act governing the
nomination, election, and composition of the Board. On July 21, 2010,
the Dodd-Frank Act was signed into law by President Obama. This
comprehensive financial reform legislation contains various provisions
that affect the governance and mandate of the MSRB. The effective date
of these provisions is October 1, 2010, which coincides with the first
day of the MSRB's 2011 fiscal year.
    The Dodd-Frank Act provides that the number of public
representatives of the Board shall at all times exceed the total number
of regulated representatives, that the membership must be as evenly
divided in number as possible between public and regulated
representatives, and that the members be knowledgeable of matters
related to the municipal securities markets.
    As for the public members, at least one must be representative of
institutional or retail investors in municipal securities, at least one
must be representative of municipal entities and at least one must be a
member of the public with knowledge of or experience in the municipal
industry. As for regulated representatives, at least one must be
associated with and representative of broker-dealers, at least one must
be associated with and representative of bank dealers, and at least one
must be associated with a municipal advisor. For the first time, the
MSRB has been authorized to promulgate rules governing the conduct of
municipal advisors who must be fairly represented on the Board.
    Although Section 975(b) of the Dodd-Frank Act provides that the
Board shall be composed of 15 members, the same section permits the
Board to increase the number of Board members, so long as the total
membership is an odd number. It also requires that the public members
be independent, as defined by the Board, of entities regulated by the
MSRB.
    In order to implement these terms of the Dodd-Frank Act by the
effective date of October 1, 2010, the MSRB proposes a rule change to
add sections (h) and (i) to Rule A-3. Section (h) defines certain terms
consistent with the Dodd-Frank Act, including the term ``independent of
any municipal securities broker, municipal securities dealer, or
municipal advisor,'' which is similar to the independence definition
used by other self-regulatory organizations. The term ``independent of
any municipal securities broker, municipal securities dealer, or
municipal advisor'' would mean that the individual has ``no material
business relationship'' with any municipal securities broker, municipal
securities dealer, or municipal advisor. The term ``no material
business relationship,'' in turn, would mean that, at a minimum, the
individual is not and, within the last two years, was not associated
with a municipal securities broker, municipal securities dealer, or
municipal advisor, and that the individual does not have a relationship
with any municipal securities broker, municipal securities dealer, or
municipal advisor, whether compensatory or otherwise, that reasonably
could affect the independent judgment or decision making of the
individual. The Board, or by delegation its Nominating Committee, may
determine that additional circumstances involving the individual
constitute a ``material business relationship'' with a municipal
securities broker, municipal securities dealer, or municipal advisor.
    Section (i) is a transitional provision intended to effectuate the
relevant governance provisions of the Dodd-Frank Act by increasing the
Board from 15 members to 21 members, who are knowledgeable of matters
related to the municipal securities markets, 11 of whom will be
independent, public representatives and 10 of whom will be regulated
representatives, as of October 1, 2010. Of the 11 public members, at
least one will be representative of institutional or retail investors,
at least one will be representative of municipal entities, and at least
one will be a member of the public with knowledge of or experience in
the municipal industry.

Of the 10 regulated representatives, at least one will be associated
with and representative of broker-dealers, at least one will be
associated with and representative of bank dealers, and at least one,
and not less than 30% of the total number of regulated representatives,
will be associated with and representative of municipal advisors. The
Board believes that such composition is fair to each regulated
constituency and to the public.
    In order to achieve this composition, the Board must elect 11 new
members--eight public representatives and three municipal advisor
representatives--prior to the start of the 2011 fiscal year. Although
the Board had previously published a notice under the existing
provisions of paragraph (a)(iii)(c) of Rule A-3 soliciting nominations
of Board candidates for fiscal year 2011, in order to ensure a fair
nomination process, the transition rule provides for a second
publication, on or after enactment of the Dodd-Frank Act, of a notice
in a national financial journal soliciting nominations for municipal
advisor candidates, with the Nominating Committee accepting
recommendations pursuant to such notice for a period of at least 14
days from the date of publication.\4\
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    \4\ The MSRB published such additional notice on July 22, 2010,
pursuant to which it received a number of additional recommendations
for persons to serve as municipal advisor representatives on the
Board.
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    Finally, the rule change provides that, in fiscal year 2011, the
Board will amend Rule A-3(c) and make other changes consistent with the
Act and the Dodd-Frank Act.
2. Statutory Basis
    The MSRB believes that the proposed rule change is consistent with
Section 15B(b) of the Act, as amended by the Dodd-Frank Act, in that it
conforms the composition of the Board to the requirements of the Dodd-
Frank Act as more fully described above.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Board does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act since it provides for fair
representation on the Board of public representatives, broker dealer
representatives, bank dealer representatives and municipal advisor
representatives.

C. Self-Regulatory Organization's Statement on Comments Received on the
Proposed Rule Change by Members, Participants, or Others

    Written comments were neither solicited nor received on the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. The Commission seeks comments on all
aspects of the MSRB's proposed rule change, including the proposed
composition of the MSRB Board and whether the number and proportion of
public representatives, broker-dealer representatives, bank
representatives, and advisor representatives is appropriate. Because
the MSRB, under the Dodd-Frank Act, now will be proposing and adopting
rules with respect to the activities of two distinct categories of
market participants--municipal securities dealers and municipal
securities advisors--is the proposed structure of the MSRB Board
designed to assure that the interests of each are appropriately
represented, and that a fair and effective regulatory regime will be
implemented both for municipal securities dealers and municipal
securities advisors? Are there alternative Board structures or other
governance arrangements that would better achieve these goals? Is
increasing the size of the MSRB Board the appropriate way to
accommodate the new representation required by the Dodd-Frank Act, or
should the new representation be accomplished by reconstituting the
current Board? Will increasing the size of the MSRB Board negatively
impact its ability to operate effectively? Comments may be submitted by
any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-MSRB-2010-08 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-MSRB-2010-08. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-MSRB-2010-08 and should be
submitted on or before September 22, 2010.\5\
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    \5\ The Commission believes that a 14-day comment period is
reasonable, given the urgency of the matter. It will provide
adequate time for comment.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-22414 Filed 9-7-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register Volume 82, Number 13 (Monday, January 23, 2017)]
[Proposed Rules]
[Pages 7751-7753]
[FR Doc No: 2017-01128]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11, 16, and 112

[Docket No. FDA-2017-D-0175]

Compliance With and Recommendations for Implementation of the
Standards for the Growing, Harvesting, Packing, and Holding of Produce
for Human Consumption for Sprout Operations; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry entitled ``Compliance
with and Recommendations for Implementation of the Standards for the
Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption for Sprout Operations.'' The draft guidance, when
finalized, will help sprout operations subject to FDA's final rule
entitled ``Standards for the Growing, Harvesting, Packing, and Holding
of Produce for Human Consumption'' (the Produce Safety Rule), and
primarily focuses on assisting such operations in complying with the
sprout-specific requirements in Subpart M (Sprouts) of the Produce
Safety Rule. The draft guidance also includes limited discussion on
certain other applicable requirements of the Produce Safety Rule. This
draft guidance may also be useful to sprout operations that are not
subject to the Produce Safety Rule that voluntarily choose to follow
the standards established by the rule.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 24, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-0175 for ``Compliance with and Recommendations for
Implementation of the Standards for the Growing, Harvesting, Packing,
and Holding of Produce for Human Consumption for Sprout Operations.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
    Confidential Submissions--To submit a comment with confidential
information that you do not wish to be made publicly available, submit
your comments only as a written/paper submission. You should submit two
copies total. One copy will include the information you claim to be
confidential with a heading or cover note that states ``THIS DOCUMENT
CONTAINS CONFIDENTIAL INFORMATION.'' We will review this copy,
including the claimed confidential information, in our consideration of
comments. The second copy, which will have the claimed confidential
information redacted/blacked out, will be available for public viewing
and posted on http://www.regulations.gov. Submit both copies to the
Division of Dockets Management. If you do not wish your name and
contact information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Division of Produce Safety, Center for Food Safety and Applied
Nutrition (HFS-317), Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>. Send one self-addressed adhesive
label to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Samir Assar, Center for Food Safety
and Applied Nutrition (HFS-317), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry
entitled ``Compliance with and Recommendations for Implementation of
the Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption for Sprout Operations.'' We are issuing
the draft guidance consistent with our good guidance practices
regulation (21 CFR 10.115). The draft guidance, when finalized, will
represent our current thinking on this topic. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
    The draft guidance for industry is intended to explain our current
thinking on how to comply with the requirements for the safe growing,
harvesting, packing and holding of produce under 21 CFR part 112,
focusing on subparts impacting sprout operations covered by Subpart M.
Topics discussed in the draft guidance include:
     General Sprout Production;
     Buildings, Tools, and Equipment;
     Cleaning and Sanitizing;
     Agricultural Water in Sprouting Operations;
     Seeds for Sprouting;
     Sampling and Testing of Spent Sprout Irrigation Water or
Sprouts;
     Environmental Monitoring; and
     Recordkeeping.
    FDA welcomes comments on any aspect of this draft guidance. We are
particularly interested in receiving information about the types of
seed or bean treatments that have been used by sprout operations and/or
seed suppliers, as well as their feasibility of use, cost, impact on
germination; scientific information related to the effectiveness in
reducing or eliminating microorganisms of public health significance;
and any variability in treatment effectiveness based on seed type.
    FDA has developed a risk assessment model to evaluate the public
health impact of seed treatment and testing of spent irrigation water
in a sprout production system and anticipates making it available in
the near future, following peer review.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the

public submit reports, keep records, or provide information to a third
party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to publish notice in the Federal Register
soliciting public comment on each proposed collection of information
before submitting the collection to OMB for approval. To comply with
this requirement, we will publish a 60-day notice on the proposed
collection of information in a future issue of the Federal Register.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the guidance.

    Dated: January 12, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-01128 Filed 1-19-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56072-56074]
[FR Doc No: 2022-19714]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-E-2258]

Determination of Regulatory Review Period for Purposes of Patent
Extension; REYVOW

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for REYVOW and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic
or written comments and ask for a redetermination by November 14, 2022.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by March 13, 2023. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 14, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-E-2258 for ``Determination of Regulatory Review Period for
Purposes

of Patent Extension; REYVOW.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug product becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product REYVOW
(lasmiditan). REYVOW is indicated for the acute treatment of migraine
with or without aura in adults. Subsequent to this approval, the USPTO
received a patent term restoration application for REYVOW (U.S. Patent
No. 7,423,050) from Eli Lilly and Company, and the USPTO requested
FDA's assistance in determining the patent's eligibility for patent
term restoration. In a letter dated April 5, 2021, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of REYVOW represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
REYVOW is 3,097 days. Of this time, 2,619 days occurred during the
testing phase of the regulatory review period, while 478 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
August 11, 2011. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on August
11, 2011.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: October 11,
2018. FDA has verified the applicant's claim that the new drug
application (NDA) for REYVOW (NDA 211280) was initially submitted on
October 11, 2018.
    3. The date the application was approved or the date of issuance of
the interim final rule controlling the drug under section 201(j) of the
Controlled Substances Act: January 31, 2020. FDA has verified the
applicant's claim that NDA 211280 was approved on October 11, 2019, and
that the Drug Enforcement Administration issued an interim final rule
controlling the product on January 31, 2020.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,786 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: September 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19714 Filed 9-12-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Notices]
[Pages 63214-63218]
[FR Doc No: 2014-25129]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0307]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA).

ACTION: Notice of applications for exemptions request for comments.

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

SUMMARY: FMCSA announces receipt of applications from 32 individuals
for exemption from the prohibition against persons with insulin-treated
diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in
interstate commerce. If granted, the exemptions would enable these
individuals with ITDM to operate CMVs in interstate commerce.

DATES: Comments must be received on or before November 21, 2014.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2014-0307 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System (FDMS) published in the Federal Register on January
17, 2008 (73 FR 3316).

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

SUPPLEMENTARY INFORMATION:

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-year period
if it finds ``such exemption would likely achieve a level of safety
that is equivalent to or greater than the level that would be achieved
absent such exemption.'' The statute also allows the Agency to renew
exemptions at the end of the 2-year period. The 32 individuals listed
in this notice have recently requested such an exemption from the
diabetes prohibition in 49 CFR 391.41(b)(3), which applies to drivers
of CMVs in interstate commerce. Accordingly, the Agency will evaluate
the qualifications of each applicant to determine whether granting the
exemption will achieve the required level of safety mandated by
statute.

II. Qualifications of Applicants

Jeffrey S. Argabright

    Mr. Argabright, 44, has had ITDM since 1999. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Argabright understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Argabright meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Ohio.

Darrell G. Brave

    Mr. Brave, 63, has had ITDM since 2005. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Brave understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Brave meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Washington.

Domingo Cantu

    Mr. Cantu, 64, has had ITDM since 2009. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Cantu understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Cantu meets the
requirements of the vision standard at

49 CFR 391.41(b)(10). His ophthalmologist examined him in 2014 and
certified that he has stable proliferative diabetic retinopathy. He
holds a Class A CDL from Washington.

Nicholas M. Cooper

    Mr. Cooper, 21, has had ITDM since 2012. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Cooper understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Cooper meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Florida.

James L. Crane

    Mr. Crane, 66, has had ITDM since 2012. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Crane understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Crane meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Mississippi.

Bobby O. Devaney

    Mr. Devaney, 59, has had ITDM since 2014. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Devaney understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Devaney meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Alabama.

Donald L. Feltman

    Mr. Feltman, 69, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Feltman understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Feltman meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Minnesota.

Benjamin T. Filip

    Mr. Filip, 61, has had ITDM since 2010. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Filip understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Filip meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from North Dakota.

Harold L. Gomez

    Mr. Gomez, 61, has had ITDM since 2009. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Gomez understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Gomez meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from Louisiana.

Arthur Gonzalez

    Mr. Gonzalez, 54, has had ITDM since 2006. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Gonzalez understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Gonzalez meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from Texas.

Charles W. Guillory

    Mr. Guillory, 63, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Guillory understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Guillory meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Louisiana.

Bernard Heffern

    Mr. Heffern, 57, has had ITDM since 2009. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or

more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Heffern understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Heffern meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from New Jersey.

John W. Hurlbert

    Mr. Hurlbert, 55, has had ITDM since 1980. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Hurlbert understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hurlbert meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from New Jersey.

Roosevelt Isaiah

    Mr. Isaiah, 69, has had ITDM since 2008. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Isaiah understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Isaiah meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from South Carolina.

William T. Jensen

    Mr. Jensen, 28, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Jensen understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Jensen meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from New Jersey.

Robert W. Johnson, Sr.

    Mr. Johnson, 74, has had ITDM since 2011. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Johnson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Johnson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from New York.

Joseph H. Karas

    Mr. Karas, 32, has had ITDM since 1987. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Karas understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Karas meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds an operator's license from New Jersey.

Randy C. Lee

    Mr. Lee, 50, has had ITDM since 2014. His endocrinologist examined
him in 2014 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Lee understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Lee meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2014 and certified that he has stable nonproliferative diabetic
retinopathy. He holds a Class A CDL from New York.

Gerald R. Lewis

    Mr. Lewis, 54, has had ITDM since 2008. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Lewis understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Lewis meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Tennessee.

John R. Miller, II

    Mr. Miller, 46, has had ITDM since 1988. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Miller understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Miller meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from Oregon.

Robert A. Nicolai

    Mr. Nicolai, 51, has had ITDM since 2008. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Nicolai understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Nicolai meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds an operator's license from
Missouri.

William P. Pearson, II

    Mr. Pearson, 33, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Pearson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Pearson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Wisconsin.

Alan M. Primus

    Mr. Primus, 63, has had ITDM since 2010. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Primus understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Primus meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Iowa.

Otto E. Reimer

    Mr. Reimer, 66, has had ITDM since 1995. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Reimer understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Reimer meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class B CDL from
Montana.

Danny L. Reimers

    Mr. Reimers, 61, has had ITDM since 2001. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Reimers understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Reimers meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds an operator's license from New Mexico.

Michael L. Reynolds

    Mr. Reynolds, 47, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Reynolds understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Reynolds meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from North Carolina.

Samuel H. Schmidt

    Mr. Schmidt, 21, has had ITDM since 1997. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Schmidt understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Schmidt meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Minnesota.

Timothy W. Selk

    Mr. Selk, 56, has had ITDM since 2009. His endocrinologist examined
him in 2014 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Selk understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Selk meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2014 and certified that he does not have diabetic retinopathy. He
holds a Class A CDL from Alaska.

Dennis J. Stanley

    Mr. Stanley, 60, has had ITDM since 2014. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Stanley understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV

safely. Mr. Stanley meets the requirements of the vision standard at 49
CFR 391.41(b)(10). His ophthalmologist examined him in 2014 and
certified that he does not have diabetic retinopathy. He holds a Class
B CDL from Illinois.

Howard J. Steinberg

    Mr. Steinberg, 65, has had ITDM since 2000. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Steinberg understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Steinberg meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from Massachusetts.

Steven M. Weimer

    Mr. Weimer, 53, has had ITDM since 2001. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Weimer understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Weimer meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

Michael L. Westbury

    Mr. Westbury, 50, has had ITDM since 2006. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Westbury understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Westbury meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds an operator's license from South
Carolina.

III. Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of business on the closing date indicated in the date section
of the notice.
    FMCSA notes that section 4129 of the Safe, Accountable, Flexible
and Efficient Transportation Equity Act: A Legacy for Users requires
the Secretary to revise its diabetes exemption program established on
September 3, 2003 (68 FR 52441) \1\. The revision must provide for
individual assessment of drivers with diabetes mellitus, and be
consistent with the criteria described in section 4018 of the
Transportation Equity Act for the 21st Century (49 U.S.C. 31305).
---------------------------------------------------------------------------

    \1\ Section 4129(a) refers to the 2003 notice as a ``final
rule.'' However, the 2003 notice did not issue a ``final rule'' but
did establish the procedures and standards for issuing exemptions
for drivers with ITDM.
---------------------------------------------------------------------------

    Section 4129 requires: (1) Elimination of the requirement for 3
years of experience operating CMVs while being treated with insulin;
and (2) establishment of a specified minimum period of insulin use to
demonstrate stable control of diabetes before being allowed to operate
a CMV.
    In response to section 4129, FMCSA made immediate revisions to the
diabetes exemption program established by the September 3, 2003 notice.
FMCSA discontinued use of the 3-year driving experience and fulfilled
the requirements of section 4129 while continuing to ensure that
operation of CMVs by drivers with ITDM will achieve the requisite level
of safety required of all exemptions granted under 49 U.S.C. 31136(e).
    Section 4129(d) also directed FMCSA to ensure that drivers of CMVs
with ITDM are not held to a higher standard than other drivers, with
the exception of limited operating, monitoring and medical requirements
that are deemed medically necessary.
    The FMCSA concluded that all of the operating, monitoring and
medical requirements set out in the September 3, 2003 notice, except as
modified, were in compliance with section 4129(d). Therefore, all of
the requirements set out in the September 3, 2003 notice, except as
modified by the notice in the Federal Register on November 8, 2005 (70
FR 67777), remain in effect.

IV. Submitting Comments

    You may submit your comments and material online or by fax, mail,
or hand delivery, but please use only one of these means. FMCSA
recommends that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that FMCSA
can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
in the search box insert the docket number FMCSA-2014-0307 and click
the search button. When the new screen appears, click on the blue
``Comment Now!'' button on the right hand side of the page. On the new
page, enter information required including the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. If you submit your comments by mail or
hand delivery, submit them in an unbound format, no larger than 8\1/2\
by 11 inches, suitable for copying and electronic filing. If you submit
comments by mail and would like to know that they reached the facility,
please enclose a stamped, self-addressed postcard or envelope.
    We will consider all comments and material received during the
comment period and may change this proposed rule based on your
comments. FMCSA may issue a final rule at any time after the close of
the comment period.

V. Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, To submit your comment online, go to http://www.regulations.gov and in the search box insert the docket number
FMCSA-2014-0307 and click ``Search.'' Next, click ``Open Docket
Folder'' and you will find all documents and comments related to the
proposed rulemaking.

    Issued on: October 10, 2014.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2014-25129 Filed 10-21-14; 8:45 am]
BILLING CODE 4910-EX-P