[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Notices]
[Pages 18156-18159]
[FR Doc No: 2023-06299]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1007]

Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year
2023

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the fee rates under the over-the-counter (OTC) monograph drug user fee
program (OMUFA) for fiscal year (FY) 2023. The Federal Food, Drug, and
Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees
from qualifying manufacturers of OTC monograph drugs and submitters of
OTC monograph order requests. This notice publishes the OMUFA fee rates
for FY 2023.

DATES: These fees are effective on October 1, 2022, and will remain in
effect through September 30, 2023.

FOR FURTHER INFORMATION CONTACT: Brandon Lee, Mitra Ramson, and the
User Fees Support Staff, Office of Financial Management, Food and Drug
Administration, 4041 Powder Mill Rd., Rm. 61075, Beltsville, MD 20705-
4304, [email protected],<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 744M of the FD&C Act (21 U.S.C. 379j-72), as added by the
Coronavirus Aid, Relief, and Economic Security Act (CARES Act),
authorizes FDA to assess and collect: (1) facility fees from qualifying
owners of OTC monograph drug facilities and (2) fees from submitters of
qualifying OTC monograph order requests. These fees are to support
FDA's OTC monograph drug activities, which are detailed in section
744L(6) of the FD&C Act (21 U.S.C. 379j-71(6)) and include various FDA
activities associated with OTC monograph drugs and inspection of
facilities associated with such products.
    For OMUFA purposes:
     An OTC monograph drug is a nonprescription drug without an
approved new drug application that is governed by the provisions of
section 505G of the FD&C Act (21 U.S.C. 355h) (see section 744L(5) of
the FD&C Act);
     An OTC monograph drug facility (MDF) is a foreign or
domestic business or other entity that, in addition to meeting other
criteria, is engaged in manufacturing or processing the finished dosage
form of an OTC monograph drug (see section 744L(10) of the FD&C Act);
     A contract manufacturing organization (CMO) facility is an
OTC monograph drug facility where neither the owner nor any affiliate
of the owner or facility sells the OTC monograph drug produced at such
facility directly to wholesalers, retailers, or consumers in the United
States (see section 744L(2) of the FD&C Act); and
     An OTC monograph order request (OMOR) is a request for an
administrative order, with respect to an OTC monograph drug, which is
submitted under section 505G(b)(5) of the FD&C Act (see section 744L(7)
of the FD&C Act).
    Under section 744M(a)(1)(A) of the FD&C Act, a facility fee for FY
2023 shall be assessed with respect to each facility that is identified
as an OTC monograph drug facility during the fee-liable period from
January 1, 2022, through December 31, 2022.\1\ Consistent with the
statute, FDA will assess and collect facility fees with respect to the
two types of OTC monograph drug facilities--MDF and CMO facilities. A
full facility fee will be assessed to each qualifying person that owns
a facility identified as an MDF (see section 744M(a)(1)(A) of the FD&C
Act), and a reduced facility fee of two-thirds will be assessed to each
qualifying person that owns a facility identified as a CMO facility
(see section 744M(a)(1)(B)(ii) of the FD&C Act). The facility fees for
FY 2023 are due on June 1, 2023 (see section 744M(a)(1)(D)(ii) of the
FD&C Act).\2\
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    \1\ Under section 744M(a)(1) of the FD&C Act, ``Each person that
owns a facility identified as an OTC monograph drug facility on
December 31 of the fiscal year or at any time during the preceding
12-month period shall be assessed an annual fee for each such
facility''. For purposes of FY 2023 facility fees, that time period
is January 1, 2022, through December 31, 2022.
    \2\ Assuming that, as we anticipate, the FY 2023 fee
appropriation will occur prior to June 1, 2023. Under section
744M(a)(1)(D)(ii), the FY 2023 facility fees are due on the later
of: (1) the first business day of June 2023 (i.e., June 1, 2023) or
(2) the first business day after the enactment of an appropriations
Act providing for the collection and obligation of FY 2023 OMUFA
fees.

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    As discussed in greater detail below:
     OTC monograph drug facilities are exempt from FY 2023
facility fees if they had ceased OTC monograph drug activities, and
updated their registration with FDA to that effect, prior to December
31, 2021 (see section 744M(a)(1)(B)(i) of the FD&C Act).
     Entities that registered with FDA during the Coronavirus
Disease 2019 (COVID-19) pandemic whose sole activity with respect to
OTC monograph drugs during the pandemic consists (or had consisted) of
manufacturing OTC hand sanitizer products \3\ are not identified as OTC
monograph drug facilities subject to OMUFA facility fees.\4\
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    \3\ The term ``hand sanitizer'' commonly refers to consumer
antiseptic rubs. However, because the Health and Human Services
(HHS) notice published January 12, 2021, referred to ``persons that
entered the over-the-counter drug market to supply hand sanitizer
products in response to the COVID-19 Public Health Emergency'' (86
FR 2420, https:www.federalregister.gov/documents/2021/01/12/2021-00237/notice-that-persons-that-entered-the-over-the-counter-drug-market-to-supply-hand-sanitizer-during), we are using the same
terminology--``hand sanitizer products''--to refer to OTC monograph
drug products intended for use (without water) as antiseptic hand
rubs or antiseptic hand wipes by consumers or healthcare personnel.
    \4\ See HHS Federal Register notice of January 12, 2021, 86 FR
2420, https://www.federalregister.gov/documents/2021/01/12/2021-00237/notice-that-persons-that-entered-the-over-the-counter-drug-market-to-supply-hand-sanitizer-during.
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    In addition to facility fees, the Agency is authorized to assess
and collect fees from submitters of OMORs, except for OMORs that
request certain safety-related changes (as discussed below). There are
two levels of OMOR fees, based on whether the OMOR at issue is a Tier 1
or Tier 2 OMOR.\5\
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    \5\ Under OMUFA, a Tier 1 OMOR is defined as any OMOR that is
not a Tier 2 OMOR (see section 744L(8) of the FD&C Act). Tier 2
OMORs are detailed in section 744L(9) of the FD&C Act.
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    For FY 2023, the OMUFA fee rates are: Tier 1 OMOR fees ($517,381),
Tier 2 OMOR fees ($103,476), MDF facility fees ($26,153), and CMO
facility fees ($17,435). These fees are effective for the period from
October 1, 2022, through September 30, 2023.\6\ This document is issued
pursuant to section 744M(a)(4) and 744M(c)(4)(B) of the FD&C Act and
describes the calculations used to set the OMUFA facility fees and OMOR
fees for FY 2023 in accordance with the directives in the statute.
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    \6\ These OMUFA fees are for FY 2023, per section 744M(a) of the
FD&C Act.
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II. Facility Fee Revenue Amount for FY 2023

A. Base Fee Revenue Amount

    Under OMUFA, FDA sets annual facility fees to generate the total
facility fee revenues for each fiscal year established by section
744M(b) of the FD&C Act. The yearly base revenue amount is the starting
point for setting annual facility fee rates. The base revenue for FY
2023 is the dollar amount of the total revenue amount for the previous
fiscal year, without certain adjustments made for that previous year,
and is $15,112,328 (see section 744M(b)(3)(B) of the FD&C Act).

B. Fee Revenue Adjustment for Inflation

    Under OMUFA, the annual base revenue amount for facility fees is
adjusted for inflation for FY 2023 and each subsequent fiscal year (see
section 744M(c)(1) of the FD&C Act). That provision states that the
dollar amount of the inflation adjustment is equal to the product of
the annual base revenue for the fiscal year and the inflation
adjustment percentage. For each of FYs 2022 and 2023, the inflation
adjustment percentage is equal to the average annual percent change
that occurred in the Consumer Price Index (CPI) for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items;
Annual Index) for the first 3 years of the preceding 4 years of
available data (section 744M(c)(1)(C) of the FD&C Act). As a result of
a geographical revision made by the Bureau of Labor and Statistics in
January 2018, the ``Washington, DC-Baltimore'' index was discontinued
and replaced with two separate indices (i.e., the ``Washington-
Arlington-Alexandria'' and ``Baltimore-Columbia-Towson'' indices). To
continue applying a CPI that best reflects the geographic region in
which FDA is located and that provides the most current data available,
the ``Washington-Arlington-Alexandria'' index is used in calculating
the inflation adjustment percentage. Table 1 provides the summary data
for the percent changes in the specified CPI for the Washington-
Arlington-Alexandria, DC-VA-MD-WV. The data are published by the Bureau
of Labor Statistics on its website: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0.

 Table 1--Annual and 3-Year Average Percent Change in CPI for Washington-Arlington-Alexandria, DC-VA-MD-WV Area
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                     Year                           2019            2020            2021         3-Year average
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Annual CPI...................................          264.78          267.16          277.73  .................
Annual Percent Change........................         1.2745%         0.8989%         3.9568%            2.0434%
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    Pursuant to the statute, the FY 2023 base revenue of $15,112,328 is
increased by 2.0434 percent, yielding an inflation adjusted base
revenue amount of $15,421,133 for FY 2023 (see section 744M(c)(1)(A)).

C. Additional Dollar Amounts

    For FY 2023, the inflation adjusted revenue amount of $15,421,133
is increased by an additional dollar amount of $6 million as specified
in the statute (see section 744M(b)(2)(E) of the FD&C Act). This yields
an adjusted fee revenue subtotal of $21,421,133.

D. Fee Revenue Adjustment for Additional Direct Cost

    Fee revenue is further adjusted for additional direct costs as
specified in the statute. In FY 2023, $4 million is added to the
facility fee revenues to account for additional direct costs (see
section 744M(c)(3)(B) of the FD&C Act). Adding the additional direct
costs amount of $4 million to $21,421,133 yields an additional direct
cost adjusted fee revenue of $25,421,133.

E. Fee Revenue Adjustment for Operating Reserve

    Under OMUFA, FDA may further increase the FY 2023 facility fee
revenue and fees if such an adjustment is necessary to provide up to 10
weeks of operating reserves of carryover user fees for OTC monograph
drug activities (see section 744M(c)(2)(B) of the FD&C Act).
Accordingly, in setting fees for FY 2023, the Agency must estimate its
carryover for FY 2023 to ensure the Agency has sufficient carryover to
continue its OTC monograph drug activities, as required under the
statute, including an

operating reserve to mitigate certain financial risks, such as under
collections, unanticipated surges in program costs, or a lapse in
appropriations. Under the statute, if FDA has carryover for OTC
monograph drug activities that would exceed 10 weeks of such operating
reserves, FDA is required to decrease FY 2023 fee revenues and fees to
provide for not more than 10 weeks of operating reserves of carryover
user fees (see section 744M(c)(2)(C) of the FD&C Act).
    Per the statute, OMUFA facility fees are not due until the third
quarter of each fiscal year (i.e., the first business day in June). To
address this timing of facility fee collections for late in the fiscal
year, the Agency must set aside additional carryover, beyond that for
an operating reserve, to sustain the Agency's OTC monograph drug
activities until the facility fees for the subsequent fiscal year are
due and payable on the first business day in June (i.e., June 3, 2024).
Thus, the Agency will require FY 2023 carryover sufficient to cover
payroll and operating expenses for the first 8 months (i.e., 35 weeks
rounded) of the following fiscal year (i.e., October 1, 2023, to May
31, 2024).
    To determine the carryover needed, the Agency starts with the
additional direct cost adjusted fee revenue of $25,421,133 (calculated
in section D), divides it by 52 to yield a weekly operating amount of
$488,868, and then multiplies the weekly operating amount by 35. Based
on this calculation, FDA requires $17,110,378 to support the program
until the FY 2024 fees are due. After running analyses on the projected
collections and obligations for FY 2023, including accounting for
possible financial risks described above, FDA estimates the FY 2023
carryover to be $17,113,657 which is the approximate amount required to
support the program through the 35-week period.
    Therefore, FDA is not applying an operating reserve adjustment for
FY 2023. As a result of the above calculations, the final FY 2023 OMUFA
target facility fee revenue is $25,421,000 (rounded to the nearest
thousand dollars).

III. Determination of FY 2023 OMOR Fees

    Under OMUFA, the FY 2023 Tier 1 OMOR fee is $517,381 and the Tier 2
OMOR fee is $103,476 (see section 744M(a)(2)(A)(i) and (ii) of the FD&C
Act, respectively) including an adjustment for inflation. OMOR fees are
not included in the OMUFA target revenue calculation, which is based on
the facility fees (see section 744M(b)(1) of the FD&C Act).
    An OMOR fee is generally assessed to each person who submits an
OMOR (see section 744M(a)(2)(A) of the FD&C Act). OMOR fees are due on
the date of the submission of the OMOR (see section 744M(a)(2)(B) of
the FD&C Act). The payor should submit the OMOR fee that applies to the
type of OMOR they are submitting (i.e., Tier 1 or Tier 2). FDA will
determine whether the appropriate OMOR fee has been submitted following
receipt of the OMOR and the fee.
    An OMOR fee will not be assessed if the OMOR seeks to make certain
safety changes with respect to an OTC monograph drug. Specifically, no
fee will be assessed if FDA finds that the OMOR seeks to change the
drug facts labeling of an OTC monograph drug in a way that would add to
or strengthen: (1) a contraindication, warning, or precaution; (2) a
statement about risk associated with misuse or abuse; or (3) an
instruction about dosage and administration that is intended to
increase the safe use of the OTC monograph drug (see section
744M(a)(2)(C) of the FD&C Act).

IV. Facility Fee Calculations

A. Facility Fee Revenues and Fees

    For FY 2023, facility fee rates are being established to generate a
total target revenue amount, as determined under the statute, equal to
$25,421,000 (rounded to the nearest thousand dollars). FDA used the
methodology described below to determine the appropriate number of MDF
and CMO facilities to be used in setting the OMUFA facility fees for FY
2023. FDA took into consideration that the CMO facility fee is equal to
two-thirds of the amount of the MDF facility fee (see section
744M(a)(1)(B)(ii) of the FD&C Act).

B. Calculating the Number of Qualifying Facilities and Setting the
Facility Fees

    For FY 2023, FDA utilized data consisting of the number of
facilities that were registered in FDA's electronic Drug Registration
and Listing System (eDRLS) to manufacture human OTC products produced
under a monograph \7\ during the FY 2022 fee-liable period (i.e.,
January 1, 2021, through December 31, 2021) and the number of
facilities that paid FY 2022 OMUFA fees, as the primary sources for
estimating the number of each facility fee type (i.e., MDF and CMO). In
addition, the Agency considered data provided by firms regarding their
operation as MDFs and CMOs during FY 2022 (i.e., October 1, 2021,
through September 30, 2022) when they were submitting OTC Monograph
User Fee Cover Sheets to pay the FY 2022 fee. These data helped FDA
estimate the number of firms operating as MDF and CMO facilities during
the FY 2023 fee-liable period (i.e., January 1, 2022, through December
31, 2022) \8\ and thus informed FDA's calculation of the number and
ratio of MDF and CMO facilities used in determining the FY 2023 fee
rates. FDA's review of data also reflected input received during the
first three quarters of the FY 2023 fee-liable period from facilities
whose manufacturing or processing practices meet the definition of fee-
eligible OTC monograph drug facilities, to help capture those
facilities that are in the market and intend to remain in the market
for FY 2023.
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    \7\ See section 744M(d) of the FD&C Act. OTC monograph drug
facilities had selected in the eDRLS the business operation
qualifiers of ``manufactures human over-the-counter drug products
produced under a monograph'' or ``contract manufacturing for human
over-the-counter drug products produced under a monograph'' and
indicated at least one of the following business operations:
finished dosage form manufacture, label, manufacture, pack, relabel,
or repack.
    \8\ Under section 744M(a)(1) of the FD&C Act, ``Each person that
owns a facility identified as an OTC monograph drug facility on
December 31 of the fiscal year or at any time during the preceding
12-month period shall be assessed an annual fee for each such
facility'' (emphasis added).
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    Those facilities that only manufacture the active pharmaceutical
ingredient of an OTC monograph drug do not meet the definition of an
OTC monograph drug facility (see section 744L(10)(A)(i)(II)) of the
FD&C Act). Likewise, a facility is not an OTC monograph drug facility
if its only manufacturing or processing activities are one or more of
the following: (1) production of clinical research supplies; (2)
testing; or (3) placement of outer packaging on packages containing
multiple products, for such purposes as creating multipacks, when each
monograph drug product contained within the overpackaging is already in
a final packaged form prior to placement in the outer overpackaging
(see section 744L(10)(A)(iii) of the FD&C Act).
    Consistent with the January 12, 2021 HHS Federal Register notice
\9\ and FDA's subsequent Federal Register notices published on March
26, 2021 and March 16, 2022 announcing the FY

2021 and FY 2022 OMUFA fees (respectively),10 11 facilities
are not identified as an ``OTC monograph drug facility'' and will not
be assessed a FY 2023 OMUFA facility fee if they: (1) were not
registered with FDA as OTC drug manufacturers prior to the HHS
declaration of the COVID-19 public health emergency on January 27,
2020; \12\ (2) registered with FDA on or after the declaration of the
COVID-19 public health emergency; and (3) registered for the sole
purpose of producing hand sanitizer products during the COVID-19 public
health emergency. We note, however, that under the FD&C Act, whether an
entity is subject to OMUFA fees has no bearing on whether the entity or
the entity's products are subject to other requirements under the FD&C
Act. FDA will continue to use its regulatory compliance and enforcement
tools to protect consumers, including from potentially dangerous or
subpotent hand sanitizers.
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    \9\ See 86 FR 2420, https://www.federalregister.gov/documents/2021/01/12/2021-00237/notice-that-persons-that-entered-the-over-the-counter-drug-market-to-supply-hand-sanitizer-during.
    \10\ See 86 FR 16223, https://www.federalregister.gov/documents/2021/03/26/2021-06361/fee-rates-under-the-over-the-counter-monograph-drug-user-fee-program-for-fiscal-year-2021.
    \11\ See 87 FR 14888, https://www.federalregister.gov/documents/2022/03/16/2022-05542/over-the-counter-monograph-drug-user-fee-rates-for-fiscal-year-2022.
    \12\ See https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
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    In undertaking the statutorily directed fee calculations, the
Agency also made certain assumptions, including that: (1) facilities
using expired Structured Product Labeling (SPL) codes in eDRLS, that
did not reregister for calendar year 2023, were no longer manufacturing
and marketing OTC monograph drugs; (2) facilities that have
deregistered in eDRLS have exited the market; (3) facilities that FDA
believes registered incorrectly as OTC monograph drug facilities (for
example, because the associated drug listings for these facilities did
not include OTC monograph drugs but instead indicated such products as
OTC drug products under an approved drug application or OTC animal drug
products) were not engaged in manufacturing or processing the finished
dosage form of an OTC monograph drug; (4) facilities that registered
but did not have an active OTC monograph drug product listing
associated in their registration profile were not manufacturing or
processing such drug products; and (5) facilities that, at the close of
FY 2022, remain on the arrears list for failure to satisfy the FY 2021
or FY 2022 facility fee are likely to be placed on the FY 2023 arrears
list as well.
    Based on the above-referenced factors and assumptions, FDA
estimates there will be 1,122 OMUFA fee-paying units. The Agency
estimates that 60 percent (1,122 x 0.60 = 673, rounded) will incur the
MDF fee and 40 percent (1,122 x 0.40 = 449, rounded) will incur the CMO
fee.
    To determine the number of full fee-paying equivalents (the
denominator) to be used in setting the OMUFA fees, FDA assigns a value
of 1 to each MDF (673) and a value of \2/3\ to each CMO (449 x \2/3\ =
299) for a full facility equivalent of 972 (rounded). The target fee
revenue of $25,421,000 is then divided by 972 for an MDF fee of $26,153
and a CMO fee of $17,435.

V. Fee Schedule for FY 2023

    The fee rates for FY 2023 are displayed in table 2.

                    Table 2--Fee Schedule for FY 2023
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                                                            FY 2023 fee
                      Fee category                             rates
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OMOR:
  Tier 1................................................        $517,381
  Tier 2................................................         103,476
Facility Fees:
  MDF...................................................          26,153
  CMO...................................................          17,435
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VI. Fee Payment Options and Procedures

    The new fee rates are for the period from October 1, 2022, through
September 30, 2023. To pay the OMOR, MDF, and CMO fees, complete an OTC
Monograph User Fee Cover Sheet, available at: https://userfees.fda.gov/OA_HTML/omufaCAcdLogin.jsp.
    A user fee identification (ID) number will be generated. Payment
must be made in U.S. currency by electronic check or wire transfer,
payable to the order of the Food and Drug Administration. The preferred
payment method is online using electronic check (Automated Clearing
House (ACH) also known as eCheck) or credit card for payments under
$25,000 (Discover, VISA, MasterCard, American Express).
    FDA has partnered with the U.S. Department of the Treasury to use
Pay.gov, a web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA website after
completing the OTC Monograph User Fee Cover Sheet and generating the
user fee ID number. Secure electronic payments can be submitted using
the User Fees Payment Portal at https://userfees.fda.gov/pay. (Note:
Only full payments are accepted through https://userfees.fda.gov/pay.
No partial payments can be made online). Once an invoice is located,
``Pay Now'' should be selected to be redirected to Pay.gov. Electronic
payment options are based on the balance due. Payment by credit card is
available for balances that are less than $25,000. If the balance
exceeds this amount, only the ACH option is available. Payments must be
made using U.S. bank accounts as well as U.S. credit cards.
    For payments made by wire transfer, include the unique user fee ID
number to ensure that the payment is applied to the correct fee(s).
Without the unique user fee ID number, the payment may not be applied,
which could result in FDA not filing an OMOR request, or other
consequences of nonpayment. The originating financial institution may
charge a wire transfer fee. Applicable wire transfer fees must be
included with payment to ensure fees are fully paid. Questions about
wire transfer fees should be addressed to the financial institution.
The account information for wire transfers is as follows: U.S.
Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY
10045, Acct. No.: 75060099, Routing No.: 021030004, SWIFT: FRNYUS33. If
needed, FDA's tax identification number is 53-0196965.
    If you are assessed an FY 2023 OMUFA facility fee and believe your
facility is not an OTC monograph drug facility as described in this
notice, please contact [email protected].

    Dated: March 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06299 Filed 3-24-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 176 (Wednesday, September 13, 2017)]
[Notices]
[Page 43034]
[FR Doc No: 2017-19383]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4332-DR; Docket ID FEMA-2017-0001]

Texas; Amendment No. 5 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Texas (FEMA-4332-DR), dated August 25, 2017, and
related determinations.

DATES: This amendment was issued September 4, 2017.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Texas is hereby amended to include the following areas
among those areas determined to have been adversely affected by the
event declared a major disaster by the President in his declaration of
August 25, 2017.

    Austin, Bastrop, DeWitt, Gonzales, Karnes, Lavaca, and Lee
Counties for Individual Assistance and assistance for debris removal
and emergency protective measures [Categories A and B], including
direct federal assistance, under the Public Assistance program.
    Aransas, Brazoria, Calhoun, Chambers, Colorado, Fayette, Fort
Bend, Galveston, Goliad, Hardin, Harris, Jackson, Jasper, Jefferson,
Liberty, Matagorda, Montgomery, Newton, Nueces, Orange, Polk, San
Jacinto, San Patricio, Tyler, Victoria, Walker, Waller, and Wharton
Counties for Public Assistance [Categories C-G] (already designated
for Individual Assistance and assistance for debris removal and
emergency protective measures [Categories A and B], including direct
federal assistance, under the Public Assistance program).

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-19383 Filed 9-12-17; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 77, Number 130 (Friday, July 6, 2012)]
[Notices]
[Pages 40120-40121]
[FR Doc No: 2012-16568]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67322; File No. SR-CBOE-2012-059]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change Relating to the Penny Pilot Program

June 29, 2012.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on June 22, 2012, the Chicago Board Options Exchange,
Incorporated (the ``Exchange'' or ``CBOE'') filed with the Securities
and Exchange Commission (the ``Commission'') the proposed rule change
as described in Items I and II below, which Items have been prepared by
the Exchange. 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\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its rules relating to the Penny
Pilot Program. The text of the proposed rule change is available on the
Exchange's Web site (http://www.cboe.com/AboutCBOE/CBOELegalRegularotyHome.aspx), at the Exchange's Office of the
Secretary, 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 Exchange 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 those statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The Penny Pilot Program is scheduled to expire on June 30, 2012.
CBOE proposes to extend the Pilot Program until December 31, 2012. CBOE
believes that extending the Pilot Program will allow for further
analysis of the Pilot Program and a determination of how the Pilot
Program should be structured in the future.
    During this extension of the Penny Pilot Program, CBOE proposes
that it may replace any option class that is currently included in the
Pilot Program and that has been delisted with the next most actively
traded, multiply listed option class that is not yet participating in
the Pilot Program (``replacement class''). Any replacement class would
be determined based on national average daily volume in the preceding
six months,\4\ and would be added on the second trading day following
July 1, 2012. CBOE will employ the same parameters to prospective
replacement classes as approved and applicable in determining the
existing classes in the Pilot Program, including excluding high-priced
underlying securities.\5\ CBOE will announce to its Trading Permit
Holders by circular any replacement classes in the Pilot Program.
---------------------------------------------------------------------------

    \4\ The month immediately preceding a replacement class's
addition to the Pilot Program (i.e. June) would not be used for
purposes of the six-month analysis. Thus, a replacement class to be
added on the second trading following July 1, 2012 be identified
based on The Option Clearing Corporation's trading volume data from
December 1, 2011 through May 31, 2012.
    \5\ See Securities Exchange Act Release No. 60864 (October 22,
2009) (granting immediate effectiveness to SR-CBOE-2009-76).
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    CBOE is specifically authorized to act jointly with the other
options exchanges participating in the Penny Pilot Program in
identifying any replacement class.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations thereunder applicable to the
Exchange and, in particular, the requirements of Section 6(b) of the
Act.\6\ Specifically, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \7\ requirements that the rules of
an exchange be designed to promote just and equitable principles of
trade, to prevent fraudulent and manipulative acts, to remove
impediments to and to perfect the mechanism for a free and open market
and a national market system, and, in general, to protect investors and
the public interest. In particular, the proposed rule change allows for
an extension of the Penny Pilot Program for the benefit of market
participants.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    CBOE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \8\ and Rule 19b-4(f)(6) thereunder.\9\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate if consistent with the protection of
investors and the

public interest, the proposed rule change has become effective pursuant
to Section 19(b)(3)(A) of the Act \10\ and Rule 19b-4(f)(6)(iii)
thereunder.\11\
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    \8\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative prior to 30 days after the date of the filing.\12\
However, pursuant to Rule 19b-4(f)(6)(iii),\13\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Commission believes
that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest because doing so will
allow the Pilot Program to continue without interruption in a manner
that is consistent with the Commission's prior approval of the
extension and expansion of the Pilot Program and will allow the
Exchange and the Commission additional time to analyze the impact of
the Pilot Program.\14\ Accordingly, the Commission designates the
proposed rule change as operative upon filing with the Commission.\15\
---------------------------------------------------------------------------

    \12\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this pre-filing requirement.
    \13\ 17 CFR 240.19b-4(f)(6)(iii).
    \14\ See Securities Exchange Act Release No. 61061 (November 24,
2009), 74 FR 62857 (December 1, 2009) (SR-NYSEArca-2009-44). See
also supra note 5.
    \15\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

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. 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 email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2012-059 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-CBOE-2012-059. This file
number should be included on the subject line if email 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
10:00 a.m. and 3:00 p.m. Copies of the 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-CBOE-2012-059 and should be
submitted on or before July 27, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2012-16568 Filed 7-5-12; 8:45 am]
BILLING CODE 8011-01-P


August 18, 2006

FINAL DISPOSITION OF PEER REVIEW COMMENTS FOR

CHARACTERIZATION OF DUST LEAD LEVELS AFTER RENOVATION, REPAIR, AND
PAINTING ACTIVITIES

GENERAL COMMENTS FROM EPA REVIEWERS

Prepared By

BATTELLE

505 King Avenue

Columbus, Ohio  43201

EPA Contract No. EP-W-04-021

Work Assignment 2-10

Prepared For

Sineta Wooten, Project Officer

John Schwemberger, Work Assignment Manager

Samuel Brown, Deputy Work Assignment Manager

Program Assessment and Outreach Branch

National Program Chemicals Division

Office of Pollution Prevention and Toxics

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue NW (7404T)

Washington, D.C.  20460

GENERAL COMMENTS ON RRP QAPP FROM EPA REVIEWERS

TABLE OF CONTENTS

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc139429704"  TABLE OF
CONTENTS	  PAGEREF _Toc139429704 \h  1

  HYPERLINK \l "_Toc139429705"  Comments from Reviewer FR6	  PAGEREF
_Toc139429705 \h  2

  HYPERLINK \l "_Toc139429706"  Comments from Reviewer FR7	  PAGEREF
_Toc139429706 \h  5

  HYPERLINK \l "_Toc139429707"  Comments from Reviewer FR8	  PAGEREF
_Toc139429707 \h  6

  HYPERLINK \l "_Toc139429708"  Comments from Reviewer FR9	  PAGEREF
_Toc139429708 \h  7

 Comments from Reviewer FR6

Comments on full dust study Plan

A very thorough Plan!  I have just a few comments:

See my June 5 comments on the dust study site selection Plan, some of
those apply here as well.  In addition, I have the following remarks:

In section 1.5.3, Study Question #3, a “by” is missing in the first
paragraph.

In section 1.5.5, Study Question #5, regarding the use of plastic ground
covering for exterior jobs—isn’t there a possibility that some of
the dust on the plastic will migrate to the edges and leave a dust
concentration at the perimeter?  Perhaps a visual inspection could be
included to check for that following the work activity.

Response:

The dust collection pans will be spread out on the plastic such that
they are representative of the area, including the perimeter.

In Table 2-4, isn’t the 2 phase/2 rooms (same unit) approach at the
Low work level 1 job and 1 site instead of 2 and 2?

Response:

Yes, this has been corrected.

Section 2.2.4 specifies the “scoop” sampling method for bare soil,
but I find the Appendix E 13.3 Soil Sampling Protocol confusing (and
I’m a former soil scientist).  On page 137 the scoop and core methods
are mentioned but the description only appears to be for the core
method.    Also, the core sampling technique as stated is
nonsensical—the text states that the samples are taken by driving the
sampler ½ inch(!) into the ground; I suggest that it should be ½ foot,
as subsequent text refers to shaving off the top ½ inch, and also
collecting a sample from the bottom inch of the six inch core.

Also in Appendix E, page 138 section C. Bare Soil Sampling Procedures,
#5 has the following text “No special effort should be made to collect
visible paint chips.  If paint chips are present, they should not be
avoided and should be included in the sample.”  Obviously, the goal of
the Procedure is a representative sample, but this guidance is
problematic—if there is only one or a few paint chips present at the
sampling location, should the inspector include it (them) because the
other samples in the composite had no chips?  In such small composites,
might a large chip significantly bias the results?  If so, perhaps a
sampling template should be used so all samples are objectively taken in
the exact same locations in reference to the center of the work.  Or
perhaps the sample taker should seek an exact sampling location that is
visually representative of the general location (assuming the eye is
good at averaging paint chips).

Response:

We will be using a standard protocol for soil collection, ASTM E1727-05
Standard Practice for Field Collection of Soil Samples for Subsequent
Lead Determination.  The soil coring tool is first driven into the
ground ½ inch before being pushed in further to 2 inches.  Only the top
½ inch of soil is retained for the sample.

Paint chips can greatly influence a soil sample.  The soil samples are
being taken before the work begins and after the containment has been
removed and the work area cleaned. Therefore, paint chips should not
have a large effect on the soil samples or the technician’s decision
on where to take the soil samples.  Note that general locations for the
soil samples are pre-specified.

Comments on dust study site selection Plan

Figure 1-1, Organizational Structure: It appears that the EPA WAM sends
direction through the contractor’s principal investigator.  Is this
correct?  In later sections of the Plan, the WAM’s point of contact is
the contractor’s project manager.

Response:

The WAM and DWAM typically interact with the principal investigator.  On
occasion, there may be interaction with the project manager.

p. 1-4: In Table 1-2’s Low Level Work column, one bullet repeats; also
in that column, should the exterior sanding and scraping be for
approximately 2 square feet, or 2 to an upper-bound-value of area?  At
what point does the area become significant enough to become a medium
level?

Response:

The list of jobs has been revised to better span the spectrum of jobs
covered by the proposed rule.  Both jobs and square footages have been
updated to be more representative of the three work levels

p. 1-4 and throughout document: the listed schedule must be updated

Response:

This has been updated.

p. 1-5: how is “reasonably cleanable condition” defined?

Response:

The initial assessment of the unit will be made by a certified risk
assessor, clearance technician, or lead abatement firm.

p. 2-5, Substrate Correction section: temperature and humidity are cited
as factors for XRF reading bias, but neither here nor later are there
indications of how these factors are accounted for.  In the instrument
calibration?  Monitored and corrected later?

Response:

The XRF testing will be completed by certified XRF technicians who are
knowledgeable about the instrument and calibration activities.  The XRF
testing will include QC checks on the operation of the instrument.
Paint lead concentrations measured by the XRF instrument will be
confirmed with paint chip samples taken prior to the start of the work.

p. 2-9, section 2.5.3 Laboratory Spikes: one NIST procedure based on
0.5% lead is cited for the preparation of one spiked sample per batch.
The spiked sample must be of similar concentration to the field samples
to be valid—is there any reason to believe that any other spiking
concentration may be needed?  If so, how will the spike be adjusted?

Response

The spike sample will include a NIST standard reference material at a
concentration that is on the same order of magnitude as what we expect
the results to be for the dust wipes.  This may include having spike
samples with ‘low’ and ‘high’ concentrations to represent the
range of dust lead we would expect from the study.  This will help
evaluate the validity of the laboratory’s analytical process.

Comments from Reviewer FR7

There is a statement in section 1.5.2 of the QAPP for the site selection
plan that "The floors of all three rooms are desired to be smooth and
cleanable, i.e., wood, vinyl, or other non-carpeted surface is strongly
desired."  I believe I have mentioned before that the calculations for
the economic analysis indicated that carpeting may be a major route of
exposure in houses with RRP jobs.  Because carpeting is harder to clean
than a non-carpeted surface, it take much longer for dust levels to fall
to background levels.  I can imagine that introducing carpeted floors
would complicate the dust study due to the difficulty in testing for
dust levels on carpeting; the problem of cleaning or replacing carpeting
after the job to ensure protection of the occupants; and the issue of
reduced robustness of the replicates created by introducing another
variable.  But screening out sites with carpeting will exclude jobs that
may have a high potential to expose residents to significant dust
levels.

Response:

We agree that carpets are an important route of exposure to leaded dust,
however, budget and time constraints do not allow us to include these
samples in the current study in a manner that will yield definitive
results to address this question.  Including carpeted surfaces in the
study would likely understate the levels of lead dust from an RRP job
due to the pre-cleaning that is necessary to obtain comparable data
across the phases of an interior job.

Comments from Reviewer FR8

It is difficult to find items in the draft study design. I came across
an item called the “cleaning verification card (see photo)”. I could
not find the photo, and I think there should be some text indicating how
the card generated is obtained.  The pages should be numbered, the
inserted chapter 9 should be an insert and not an appendix.

Response:

The photos of the cleaning verification cards are included in the Full
Study QAPP.  The cards are currently obtained from the docket of the
proposed rule found at   HYPERLINK "http://www.regulations.gov"
www.regulations.gov , Docket ID: EPA-HQ-OPPT-2005-0049.  The page
numbering system has been modified so that all study and appendix pages
are easy to identify.

Comments from Reviewer FR9

Additional Comments on documentation provided: “Study Design and QAPP
for RRP Field Study”:

p. 1-1 Sec. 1.6 The contractors that will be conducting the renovation
work for this study are required to be certified as Lead Safe
Renovators. How will the impact of their high skill level relative to
other renovation workers be evaluated?

Response:

All contractors will undergo Lead Safe Renovation training.  In the
state of Ohio, only one member of the contractor crew must be certified
as a Lead-Safe Renovator.  We are not hiring lead abatement firms to do
the job and do not anticipate that the contractors will have a high
skill level with respect to lead based paint activities. Study
contractors will follow the protocol laid out in the training materials
for the study and all activities will be monitored by the site
supervisor.

p. 1-7 Sec. 1.7 and Appendix C. Form 2. Will the property sketch for
exterior sites show neighboring buildings? If neighboring buildings are
close and contain flaking/chipping LBP they could cross-contaminate the
test site.

Response:

The property sketch will include the distances to property lines or
other boundaries, including neighboring buildings.  The study protocol
also includes an evaluation of background concentrations due to
cross-contamination through sample collection trays set out prior to
starting an exterior job.

p. 2-10 Sec. <IP_ADDRESS> If TSP is not used, what is the recommendation for
the detergent?

Response:

TSP will not be used for the cleaning in this study.  After consulting
with firms familiar with abatement cleaning, it has been decided that
Simple Green will be used as the cleaning detergent.

p. 2-15 Sec. <IP_ADDRESS> The description for cleaning verification of the
interior sills indicate that dry cloth wiping will be repeated until it
matches the cleaning verification card. No maximum number of repeats are
indicated in this section. However, on p.1-10 Sec 1.5.6, a maximum of 4
cleanings with a dry cloth are described as the cleaning verification
procedure.

Response:

The maximum number of attempts with the dry cloth is 4 for both
windowsills and floor surfaces.  This is reflected consistently in the
text.

p. 2-15 Sec. <IP_ADDRESS> What precautions are taken to prevent
cross-contamination of the cleaning cloths by the long-handled
application devices?

Response:

The cleaning cloths are used only for verification purposes.  A single
cleaning cloth is used only on one zone of the floor or one windowsill,
preventing any problems with cross-contamination.  Immediately after
each use, they will be placed in individual plastic bags to be saved for
quality assurance purposes.

p. 2-18, Sec. 2.2.3 NIOSH 7082 air sampling method is designed for
8-hour sampling period. If the job lasts longer than 8 hours, will the
filter be changed?

Response:

The air monitor filters (for both indoor and personal) will be sampled
at three stages for interior jobs and only during the work stage for
exterior jobs.  No single stage should take more than eight hours to
complete, by study design.  If, however, eight hours pass during any
single stage, the air filter will be changed to ensure data quality.

p. 2-19 Sec. 2.2.6 Last sentence on page is incomplete.

Response:

Sentence has been revised.

p. 2-20 Sec. 2.4 Method D3335 is an atomic absorption spectroscopy
method not an ICP-MS method. D3335 is not included in Appendix F. EPA
Method 3050B, which is included in Appendix F, is an ICP-MS method.

Response:

The analytical methods have been revised and reflect the methods used by
Schneider Laboratories, Inc., the NLLAP-recognized laboratory selected
to analyze all environmental samples for this study.

p. 2-23 Sec. 2.7 Soil should be added to the sample types to be
analyzed.

Response:

 Soil samples are included in the study and all relevant information has
been updated in the QAPP.

Additional Comments on documentation provided: “QAPP for RRP Field
Study Site Selection”:

p. 2.7 Sec. 2.2.3 and p. 2-12 Sec. 2.10 Is the area of the paint chip
collected measured and recorded so that the lead levels can be reported
as mg/cm2 as well as   SEQ CHAPTER \h \r 1 g/g? This information
would be useful in estimating the total lead disturbed by a given RRP
job.

Response:

The detailed sampling protocol calls for 2 inch by 2 inch paint chip
samples.  The exact dimensions of the sampled chip will be recorded by
the field technician on the paint chip sample collection form.

p. 2-8, Sec 2.4 Method D3335 is an extraction procedure with atomic
absorption spectroscopy analysis not ICP-MS. D3335 is not included in
Appendix B but the extraction method E1645 is in Appendix B. No ICP-MS
procedure is included in the Appendices.

Response:

The analytical methods have been revised and reflect the methods used by
Schneider Laboratories, Inc., the NLLAP-recognized laboratory selected
to analyze all environmental samples for this study.

Appendix A. The E1729 – 99 method is no longer an active standard and
has been superseded by E1729-05.

Response:

 The appendix has been updated to reflect that paint chip samples will
be collected according to ASTM E1729-05 Standard Practice for Field
Collection of Dried Paint Samples for Subsequent Lead Determination.

Appendix B.  Analytical Methods.  E1645 is included in Appendix but is
not referenced in the text. E1645 is an extraction method not an
analytical method.

Response:

The analytical methods have been revised and reflect the methods used by
Schneider Laboratories, Inc., the NLLAP-recognized laboratory selected
to analyze all environmental samples for this study.

Appendix B.  Analytical Methods. There are no analytical methods
included in this Appendix.

Response:

The analytical methods have been revised and reflect the methods used by
Schneider Laboratories, Inc., the NLLAP-recognized laboratory selected
to analyze all environmental samples for this study.

Samples:

Samples that might provide additional information within the context of
the questions being asked:

The design for the child-occupied facilities (COFs) would be improved by
conducting two jobs, rather than one, from each job category.

Response:

While increasing the number of jobs performed would increase the amount
of data for analysis, time and budget constraints prohibit doubling the
number of jobs for COFs.

An estimate of potential lead cross-contamination from adjacent
buildings, roadways, air-entrained soil, etc. needs to be added to the
exterior sample collection design.  Prior to beginning work and setting
up containment, dust collection trays should be placed in the same
locations that will be used during the renovations. The length of
exposure should equal the time that the dust collection trays will be
exposed during the renovation. If no additional exterior samples can be
added to this study, I would recommend the substitution of these
cross-contamination check samples for the soil samples currently
included in the design.

Response:

 We agree that sampling background concentrations for
cross-contamination estimates is a valuable addition to the study. The
study protocol has now been modified to sample dust collection trays
before exterior experiments begin.

There are no samples being collected during the renovation that will
provide lead concentrations of soil/dust tracked into the house from the
outside or from other parts of the building that might contribute to the
hallway lead concentrations

Response:

Soil samples from three exterior locations will be collected prior to
the start of interior jobs to evaluate potential track-in from the
outside. The three samples will be taken from bare soil nearest to (1)
the entryway to the building used by the workers, (2) the walkway from
the entryway to the street, and (3) a window closest to the work area.
Track-in from other parts of the building should not be an issue due to
the thorough cleaning of the property prior to the start of the work.

Samples providing limited value in addressing the study questions:

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&determine if there was any contamination of soil due to study
activities.  For exterior jobs, soil samples are valuable in addressing
the effectiveness of the plastic containment, as well as assessing
potential track-in.

Page   PAGE  1  of 10

August 18, 2006