[Federal Register: October 23, 2008 (Volume 73, Number 206)]
[Notices]
[Page 63153-63157]
[DOCID:fr23oc08-62]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0546]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Electronic Data Collection Using MedWatch\Plus\ Portal
and Rational Questionnaire

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the use of MedWatch\Plus\ Portal and
Rational Questionnaire to collect electronically all adverse event,
consumer complaint/product problem and medication use error data
submitted to FDA.

DATES: Submit written or electronic comments on the collection of
information by December 22, 2008.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under 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 provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Electronic Data Collection Using MedWatch\Plus\ Portal and Rational
Questionnaire--21 CFR 310.305, 314.80, 314.98, 514.80, 600.80, 1271.350
and Part 803

    FDA is implementing electronic data collection to improve adverse
event reporting across the agency. FDA's current processes and systems
for adverse event reporting vary across its centers and are not optimal
for the efficient collection of voluntary and mandatory adverse event
reports, product problems/consumer complaints, or errors associated
with the use of FDA-regulated products. Current FDA reporting forms
(Forms FDA 3500, 3500A, 1932, and 1932a) are an outgrowth of a paper
process era and frequently result in the submission of inconsistent and
poor quality information. In addition, the agency is limited in its
ability to modify its paper forms to keep pace with changes in the
types of regulated products and the information necessary to meet
evolving standards to ensure post market safety. Further, the existing
supporting business processes are not able to efficiently manage the
information being provided on the paper forms. For example, the upfront
data integrity

constraints on required (vital) data limit the extent of reviewable
information on items such as reporter identification of one or more
subject product types (animal and human food/feed, drug - animal or
human, device, etc.), reporter name, date of occurrence, related
details, and follow-up information. Data collected on paper forms must
be manually transcribed into an electronic format for usability and
analysis. Furthermore, these forms are not very intuitive for a casual
reporter (e.g., consumers of FDA-regulated products), that is, the
paper forms lack the features available in an electronic system that
assist a new user in understanding what information is being requested.
    FDA has launched the development and implementation of a new
electronic system for collecting, submitting and processing adverse
event reports and other safety information for all FDA-regulated
products. This new system, MedWatch\Plus\ Portal, will enhance the
current MedWatch collection system and integrate the agency's existing
safety reporting systems into the various FDA Adverse Event Report
Systems (FAERS). FAERS will enable FDA staff to more efficiently
analyze thousands of safety reports and to identify potential safety
problems earlier than would be possible using paper forms. The
MedWatch\Plus\ Portal provides one central point-of-entry for persons
submitting information to FDA. The agency believes that one central
point-of-entry will better enable persons to submit their information.
In addition, mandatory reporters will be able to use the Internet to
access the MedWatch\Plus\ Portal to report safety concerns about
dietary supplements, nonprescription drugs, and human and animal food,
thus fulfilling the mandatory reporting requirements of the Dietary
Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA)
(Pub. L. 109-462) and the Food and Drug Administration Amendments Act
of 2007 (FDAAA) (Pub. L. 110-85).
    The MedWatch\Plus\ Portal involves the development of a single Web-
based portal and a user-friendly data collection tool, the ``Rational
Questionnaire,'' which will make it easy for anyone to report a safety
problem. The Rational Questionnaire will ask users simple questions to
help guide them to determine what information they should provide.
Anyone will be able to use the questionnaire to submit adverse event,
product problem/consumer complaint, and medication use error reports to
the FDA. For example, a healthcare practitioner could report an adverse
event; a medical device maker could report a safety concern about a
product; a pet owner could report a problem that their pet experienced
associated with the use of an animal drug or animal food; a parent
could report a reaction that their child experienced associated with
the use of a cosmetic; and a consumer could report a concern about a
drug they are taking at home, or about a food that may have made them
ill. The system will compile the users' responses into a standardized
report that would be routed to the appropriate FDA organizational
component(s) for review and analysis.
    There are several types of information that will be submitted to
FDA via the MedWatch\Plus\ Portal and Rational Questionnaire. Some of
the information is required to be submitted to FDA (mandatory
reporting) and some of the information is submitted voluntarily
(voluntary reporting). The majority of the information to be collected
using the MedWatch\Plus\ Rational Questionnaire has been approved
previously by OMB under the Paperwork Reduction Act. Recently,
additional information collection has been mandated by DSNDCPA and
FDAAA. A complete list of information collections, their current OMB
approval numbers, as well as citations to the relevant statute,
regulation or guidance information for each is depicted in table 1 of
this document.

                                        Table 1.--Information Collections
----------------------------------------------------------------------------------------------------------------
                                                                            Relevant Statute,
                                                                              Regulation or     Mandatory (M) or
             FDA Center                  FDA Form No.         OMB No.            Guidance        Voluntary (V)
                                                                               Information
----------------------------------------------------------------------------------------------------------------
CBER/CDER                                          3500           0910-029  MedWatch Form FDA                  V
                                                                              3500, Voluntary
                                                                                Reporting
                                                                                Instructions.
----------------------------------------------------------------------------------------------------------------
CBER/CDER                                         3500A          0910-0291    21 CFR 310.305,                  M
                                                                              314.80, 314.98,
                                                                                600.80 and
                                                                                1271.350.
----------------------------------------------------------------------------------------------------------------
CDRH                                               3500          0910-0291  MedWatch Form FDA                  V
                                                                              3500, Voluntary
                                                                                Reporting
                                                                                Instructions.
----------------------------------------------------------------------------------------------------------------
CDRH                                              3500A          0910-0291    21 CFR Part 803                  M
----------------------------------------------------------------------------------------------------------------
CFSAN                                              3500          0910-0291               None                  V
----------------------------------------------------------------------------------------------------------------
CFSAN\*\                                          3500A    OMB approval is   Pub. L. 109-462;                  M
                                                               in process.  Section 761(b)(1)
                                                                               of the Federal
                                                                              Food, Drug, and
                                                                            Cosmetic Act (the
                                                                              act) (21 U.S.C.
                                                                              379aa-1(b)(1)).
----------------------------------------------------------------------------------------------------------------

CFSAN/CVM\*\                                       None        This notice    Pub. L. 110-85;                  M
                                                         solicits comments     Section 417 of
                                                          on this proposed        the Act (21
                                                           new collection.    U.S.C. 350(f)).
----------------------------------------------------------------------------------------------------------------
CVM                                               1932a          0910-0284         Veterinary                  V
                                                                                Adverse Drug
                                                                            Reaction, Lack of
                                                                            Effectiveness, or
                                                                               Product Defect
                                                                              Report Form and
                                                                                Instructions.
----------------------------------------------------------------------------------------------------------------
CVM                                                1932          0910-0284      21 CFR 514.80                  M
----------------------------------------------------------------------------------------------------------------
CVM\*\                                             None        This notice    Pub. L. 110-85;                  V
                                                         solicits comments    Section 1002 of
                                                          on this proposed             FDAAA.
                                                           new collection.
----------------------------------------------------------------------------------------------------------------
ORA                                                None        This notice               None                  V
                                                         solicits comments
                                                          on this proposed
                                                           new collection.
----------------------------------------------------------------------------------------------------------------
\*\ New reporting requirements included in DSNDCPA and FDAAA.

    The single portal and a harmonized, Web-based format for submitting
safety information will greatly enhance the ability of FDA to protect
the public health. FDA will analyze electronic adverse event and safety
reports for all marketed products and track safety signals throughout
the life cycle of FDA-regulated products. FDA intends to review the
information the agency receives to ensure that the submitters comply
with the criteria established by the Federal Food, Drug, and Cosmetic
Act (the act), where required.
    Description of respondents: The respondents to this collection of
information include all persons submitting mandatory or voluntary
information electronically to FDA via the MedWatch\Plus\ Portal and
Rational Questionnaire.
    FDA expects that all of its centers and the Office of Regulatory
Affairs (ORA) will be utilizing the electronic reporting capabilities
of MedWatch\Plus\ Portal by Fiscal Year 2011. Thus, FDA has prepared
its estimate of the annual reporting burden on the basis that the
majority of all submissions will be submitted electronically.
    FDA estimates the burden of this information collection as follows:

                                                     Table 2.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours Per
                     FDA Activity                          Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voluntary View                                                     37,565                     1             37,565                0.6             22,539
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mandatory View using MedWatch\Plus\ Rational                          645                   199            128,403                1.0            128,403
 Questionnaire\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mandatory View using direct Gateway-to-Gateway                      2,578                 199.2            513,613                0.6            308,168
 transmission\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reportable Food (human and animal) Mandatory View                   1,200                     1              1,200                0.6                720
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reportable Food (human and animal) Voluntary View                   1,200                     1              1,200                0.6                720
--------------------------------------------------------------------------------------------------------------------------------------------------------
Early Warning Recall Voluntary View                                   540                     1                540                0.6                324
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                460,874
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

\2\ The reporter may choose to use the MedWatch\Plus\ Rational Questionnaire or a direct Gateway-to-Gateway transmission to submit a Mandatory report.
  FDA believes that these are different reporting burdens for these two types of transmission of information. The reporting burden for use of the
  MedWatch\Plus\ Rational Questionnaire Mandatory View is estimated to be 1 hour. The reporting burden for a direct Gateway-to-Gateway transmission is
  estimated to be 0.60 hours. Current reporting estimates indicate that approximately 80% of the Mandatory Reports would be submitted via a Gateway-to-
  Gateway transmission and 20% of reports would be received via the MedWatch\Plus\ Rational Questionnaire in the future. The Mandatory View reporting
  burden estimates reflect this calculation.

    The term ``Voluntary View'' refers to the MedWatch\Plus\ Rational
Questionnaire as it appears to a respondent submitting a voluntary
report. The term ``Mandatory View'' refers to the Gateway-to-Gateway
and the MedWatch\Plus\ Rational Questionnaire as it appears to a
respondent submitting a mandatory report. The estimated number of
responses and hours per response for the voluntary view and the
mandatory view are based on FDA's experience and the average number of
voluntary reports and mandatory reports submitted to FDA in 2007 (and
in the case of mandatory dietary supplement reports, those submitted to
FDA from January 1, 2008 to April 15, 2008) via the existing methods of
submission, including paper submission. The term, ``Reportable Food
(human and animal) Mandatory View'' refers to the MedWatch\Plus\
Rational Questionnaire as it appears to a respondent submitting a
mandatory report under section 417 of the act. The term, ``Reportable
Food (human and animal) Voluntary View'' refers to the MedWatch\Plus\
Rational Questionnaire as it appears to the respondent submitting a
voluntary report under section of 417 of the act. The estimated number
of responses and hours per response for the reportable food (human and
animal) mandatory and voluntary views are based on FDA's experience
with reports recently submitted to FDA that would be considered
``Reportable Food'' reports in the future. The term, ``Early Warning
Recall Voluntary View,'' refers to the MedWatch\Plus\ Rational
Questionnaire as it appears to a respondent submitting a mandatory
report under FDAAA Section 1002 of the act (Pub. L. 110-85). The
estimated number of responses and hours per response for the early
warning recall voluntary view are based on FDA's experience with
reports recently submitted to FDA that would be considered ``Early
Warning Recall'' reports in the future.
    In an effort to meet the needs of all reporters, the Rational
Questionnaire will allow for the submission of a report by completing
certain minimum data elements. Both mandatory and voluntary reporters
will see and be provided the opportunity to submit additional optional
information. A Reporter can answer one, a few, or all of the optional
questions. Reporters are strongly encouraged to submit as much optional
information as possible. This will help to ensure the FDA has
sufficient information to identify products and problems, and enhance
their ability to address these problems.
    The optional questions serve a purpose for both the Reporter and
the FDA. The Reporter may believe that additional information is needed
for FDA to fully understand the event/problem and the optional
questions provide an opportunity to provide such information. For the
FDA, the optional questions may aid in fully understanding the problem
and may eliminate the need for extensive follow up with the Reporter.
Because Reporters can choose to answer none, one, a few, or all of the
optional questions, we estimated the maximum time needed to submit a
safety report online for both voluntary and mandatory reporters in the
hours per response column in table 2 of this document.
    The agency's estimate of the number of respondents and the total
annual responses in table 2 is based on the mandatory and voluntary
reports submitted to the centers and ORA. The estimated total annual
responses in table 2 are based on initial reports. Follow-up reports,
if any, are not counted as new reports. FDA estimates that it will
receive 37,565 voluntary reports [23,033 (CBER/CDER) + 4,369 (CDRH) +
5,000 (CFSAN) + 163 (CVM) + 5,000 (ORA) = 37,565]. FDA estimates that
it will receive 642,016 mandatory reports [459,121 (CBER/CDER) +
146,274 (CDRH) + 856 (CFSAN) + 35,765 (CVM) + 0 (ORA) = 642,016].
    FDA received 23,033 voluntary reports to CBER/CDER during 2007.
Based on this experience, FDA estimates that CBER and CDER,
collectively, will receive 23,033 voluntary reports annually from
23,033 users of the electronic reporting system. FDA estimates the
reporting burden for a voluntary report to be 0.6 hours, for a total
burden of 13,820 hours (23,033 reports x 0.6 hours = 13,819.8 hours).
    FDA received 459,121 mandatory reports to CBER/CDER during 2007.
Based on this experience, FDA estimates that CBER and CDER,
collectively, will receive 459,121 mandatory reports annually from 600
users of the electronic reporting system. FDA estimates the maximum
reporting burden for a mandatory report to be 1 hour, for a total
burden of 459,121 hours ((459,121 reports x 1 hour) or a minimum burden
of 312,202 hours with ((459,121 reports x 80% x 0.60 hour) + (459,121
reports x 20% x 1 hour) = 312,202.28 hours).
    FDA received 4,369 voluntary reports to CDRH during 2007. Based on
this experience, FDA estimates that CDRH will receive 4,369 voluntary
reports annually from 4,369 users of the electronic reporting system.
FDA estimates the reporting burden for a voluntary report to be 0.6
hours, for a total burden of 2,621 hours (4,369 reports x 0.6 hours =
2,621.4 hours).
    FDA received 146,274 mandatory reports to CDRH during 2007. Based
on this experience, FDA estimates that CDRH will receive 146,274
mandatory reports annually from 1,665 users of the electronic reporting
system (a group comprised of facilities, importers, and manufacturers).
FDA estimates the maximum reporting burden for a mandatory report to be
1 hour, for a total burden of 146,274 hours (146,274 reports x 1 hour =
146,274 hours) or a minimum burden of 99,466 hours with ((146,274
reports x 80% x 0.60 hour) + (146,274 reports x 20% x 1 hour) =
99,466.32 hours). FDA received 5,000 voluntary reports to CFSAN during
2007. Based on this experience, FDA estimates that CFSAN will receive
5,000 voluntary reports annually from 5,000 users of the electronic
reporting system. FDA estimates the reporting burden for a voluntary
report to be 0.6 hours, for a total burden of 3,000 hours (5,000
reports x 0.6 hours = 3,000 hours).
    FDA received 214 mandatory dietary supplement reports to CFSAN from
January 1, 2008, to April 15, 2008. Based on this experience, FDA
estimates that CFSAN will receive 856 mandatory reports annually from
150 users of the electronic reporting system. FDA estimates the maximum
reporting burden for a mandatory report to be 1 hour, for a total
burden of 856 hours (856 reports x 1 hour = 856 hours) or a minimum
burden of 582 hours with ((856 reports x 80% x 0.60 hour) + (856
reports x 20% x 1 hour) = 582.08 hours).
    FDA received 163 voluntary reports to CVM during 2007. Based on
this experience, FDA estimates that CVM will receive 163 voluntary
reports annually from 163 users of the electronic reporting system. FDA
estimates the reporting burden for a

voluntary report to be 0.6 hours for a total burden of 98 hours (163
reports x 0.6 hours = 97.8 hours).
    FDA received 35,765 mandatory reports to CVM during 2007. Based on
this experience, FDA estimates that CVM will receive 35,765 mandatory
reports annually from 808 users of the electronic reporting system. FDA
estimates the maximum reporting burden for a mandatory report to be 1
hour, for a total burden of 35,765 hours (35,765 reports x 1 hour =
35,765 hours) or a minimum burden of 24,320 hours with ((35,765 reports
x 80% x 0.60 hour) + (35,765 reports x 20% x 1 hour) = 24,320.20
hours).
    FDA received 5,000 voluntary reports to ORA during 2007. Based on
this experience, FDA estimates that ORA will receive 5,000 voluntary
reports annually from 5,000 users of the electronic reporting system.
FDA estimates the reporting burden for a voluntary report to be 0.6
hours, for a total burden of 3,000 hours (5,000 reports x 0.6 hours =
3,000 hours). ORA does not receive mandatory reports.
    FDAAA, Section 1005, the Reportable Food Registry, established new
electronic mandatory and voluntary reporting requirements for instances
of ``reportable'' food, meaning an article of food (other than infant
formula) for which there is a reasonable probability that the use of,
or exposure to, such article of food will cause serious adverse health
consequences or death to humans or animals. FDA received 625 voluntary
food complaints leading to adverse events from January 1, 2008, to June
30, 2008, and there were 206 and 182 Class 1 Recalls for human food in
Fiscal Years 2006 and 2007, respectively. Based on these experiences,
FDA estimates that FDA could receive 200 to 1,200 ``reportable'' food
reports annually from 200 to 1,200 mandatory and voluntary users of the
electronic reporting system. FDA will utilize the upper-bound estimate
of 1,200 for these calculations. FDA estimates the reporting burden for
a mandatory ``reportable'' food report to be 0.6 hours, for a total
burden of 720 hours (1,200 reports x 0.6 hours = 720 hours). FDA
estimates the reporting burden for a voluntary ``reportable'' food
report to be 0.6 hours, for a total burden of 720 hours (1,200 reports
x 0.6 hours = 720 hours).
    FDAAA, Section 1002, Early Warning Recall, mandated the FDA
establish a system to receive voluntary pet food complaint reports and
provide an Early Warning Recall system for the public. FDA received 270
voluntary pet food reports from January 1, 2008 to June 30, 2008. FDA
received 10,740 and 99 pet food complaints in FY 2007 and 2006,
respectively. Based on these experiences, FDA estimates that FDA could
receive 540 voluntary pet food reports annually from 540 users of the
electronic reporting system. FDA estimates the reporting burden for a
voluntary ``Early Warning Recall'' report to be 0.6 hours, for a total
burden of 324 hours (540 reports x 0.6 hours = 324 hours).
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: October 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-25211 Filed 10-22-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80365-80366]
[FR Doc No: 2023-25479]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-381, OMB Control No. 3235-0434]

Submission for OMB Review; Comment Request; Extension: Rule 15g-2

Upon Written Request, Copies Available From: U.S. Securities and
Exchange Commission, Office of FOIA Services, 100 F Street NE,
Washington, DC 20549-2736

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.)(``PRA''), the Securities and
Exchange Commission (``Commission'') has submitted to the Office of
Management and Budget (``OMB'') a request for extension of the
previously approved collection of information discussed below.
    Rule 15g-2 (17 CFR 240.15g-2) (The ``Penny Stock Disclosure Rule'')
under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.)
(``Exchange Act'') requires broker-dealers to provide their customers
with a risk disclosure document, as set forth in Schedule 15G, prior to
their first non-exempt transaction in a ``penny stock.'' As amended,
the rule requires broker-dealers to obtain written acknowledgement from
the customer that he or she has received the required

risk disclosure document. The amended rule also requires broker-dealers
to maintain a copy of the customer's written acknowledgement for at
least three years following the date on which the risk disclosure
document was provided to the customer, the first two years in an
accessible place. Rule 15g-2 also requires a broker-dealer, upon
request of a customer, to furnish the customer with a copy of certain
information set forth on the Commission's website.
    The risk disclosure documents are for the benefit of the customers,
to assure that they are aware of the risks of trading in ``penny
stocks'' before they enter into a transaction. The risk disclosure
documents are maintained by the broker-dealers and may be reviewed
during the course of an examination by the Commission.
    The Commission estimates that approximately 175 broker-dealers are
engaged in penny stock transactions and that each of these firms
processes an average of three new customers for penny stocks per week.
The Commission further estimates that half of the broker-dealers send
the penny stock disclosure documents by mail, and the other half send
them through electronic means such as email. Because the Commission
estimates the copying and mailing of the penny stock disclosure
document takes two minutes, this means that there is an annual burden
of 27,456 minutes, or 447 hours, for this third-party disclosure burden
of mailing documents. Additionally, because the Commission estimates
that sending the penny stock disclosure document electronically takes
one minute, the annual burden is 13,728 minutes, or 229 hours, for this
third-party disclosure burden of emailing documents.
    Broker-dealers also incur a recordkeeping burden of approximately
two minutes per response when filing the completed penny stock
disclosure documents as required pursuant to the Rule 15g-2(c), which
means that the respondents incur an aggregate recordkeeping burden of
54,600 minutes, or 910 hours.
    Furthermore, Rule 15g-2(d) requires a broker-dealer, upon request
of a customer, to furnish the customer with a copy of certain
information set forth on the Commission's website, which takes a
respondent no more than two minutes per customer. Because the
Commission estimates that a quarter of customers who are required to
receive the Rule 15g-2 disclosure document will request that their
broker-dealer provide them with the additional microcap and penny stock
information posted on the Commission's website, the Commission
therefore estimates that each broker-dealer respondent processes
approximately 39 requests for paper copies of this information per year
or an aggregate total of 78 minutes per respondent, which amounts to an
annual burden of 13,650 minutes, or 228 hours. There was an overall
decrease in the total burden hours because the number of registered
broker-dealers the Commission estimates will be engaged in penny stock
transactions decreased from 182 to 175.
    The Commission does not maintain the risk disclosure document.
Instead, it must be retained by the broker-dealer for at least three
years following the date on which the risk disclosure document was
provided to the customer, the first two years in an accessible place.
The collection of information required by the rule is mandatory. The
risk disclosure document is otherwise governed by the internal policies
of the broker-dealer regarding confidentiality, etc.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent by December 18, 2023 to
    (i) www.reginfo.gov/public/do/PRAMain and (ii) David Bottom,
Director/Chief Information Officer, Securities and Exchange Commission,
c/o John Pezzullo, 100 F Street NE, Washington, DC 20549, or by sending
an email to: [email protected].

    Dated: November 14, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-25479 Filed 11-16-23; 8:45 am]
BILLING CODE 8011-01-P


Chapter 150:		CONTROL OF EMISSIONS FROM OUTDOOR WOOD BOILERS

SUMMARY:	This regulation establishes particulate emission standards,
siting criteria and labeling requirements for outdoor wood boilers,
including outdoor pellet boilers.

Applicability

A.	This regulation applies statewide.

B.	This regulation applies to any manufacturer, supplier, distributor or
person intending to sell, lease, distribute, or market, an outdoor wood
boiler, including an outdoor pellet boiler, in the State of Maine that
meets the definition of an outdoor wood boiler and to any person who
installs, operates or owns an outdoor wood boiler, including an outdoor
pellet boiler.

This regulation applies to outdoor wood boilers, including outdoor
pellet boilers, with a rated thermal input of less than 3 MMBtu/hr.
Boilers with a rated thermal heat input of 3 MMBtu/hr or greater are
subject to Chapter 103 Fuel Burning Equipment Particulate Emission
Standard of the Department’s Regulations.

Definitions

The following terms, as used in this Chapter, have the following
meanings:

A.	Clean wood.  “Clean wood” means wood that has no paint, stain, or
other types of coatings, and wood that has not been treated with,
including but not limited to, copper chromium arsenate, creosote, or
pentachlorophenol.

B.	Commercial outdoor wood boiler.  “Commercial outdoor wood boiler”
means any outdoor wood boiler, except for those outdoor wood boilers
used solely for space heating or domestic hot water, used to service a
commercial establishment.

C.	Distribute or sell.  “Distribute or sell” means to distribute,
sell, advertise for sale, offer for sale, lease, ship, deliver for
shipment, release for shipment, or receive and (having so received)
deliver or offer to deliver.  This term does not include the
distribution or sale by a manufacturer of an outdoor wood boiler that is
installed outside the State of Maine.

D.	Manufacturer.  “Manufacturer” means any person who constructs or
imports for the distribution or sale into the United States an outdoor
wood boiler.

E.	New outdoor wood boiler.  “New outdoor wood boiler” means an
outdoor wood boiler that is not installed and/or operational at the
intended location of use as of the effective date of this Chapter.

F.	Nuisance.  “Nuisance” means emission of air contaminants to the
outdoor atmosphere of such quantity, characteristic or duration that may
be injurious to human, plant or animal life or to property, or that
unreasonably interferes with the comfortable enjoyment of life or
property.

G.	Opacity.  “Opacity” means the degree to which emissions other
than water reduce the transmission of light and obscure the view of an
object in the background.

H.	Outdoor wood boiler.  “Outdoor wood boiler” (also known as
outdoor wood-fired hydronic heater, water stove or outdoor wood furnace)
means a fuel burning device that: (1) is designed to burn wood, biomass
fuel products or other approved solid fuels; (2) the manufacturer
specifies for outdoor installation or installation in structures not
normally occupied by humans (e.g., sheds) or is an indoor-rated device
housed in a modular or containerized structure; and (3) heats building
space or water, or both, through the distribution, typically through
pipes for a fluid or ducts for air, of a fluid or air heated in the
device.

I.	Outdoor pellet boiler.  “Outdoor pellet boiler” means an outdoor
wood boiler designed and warranted by the manufacturer specifically to
burn pellet fuel with metered fuel and air feed and controlled
combustion engineering, which is operated according to the
manufacturer’s specifications and burns only pellet fuel.

J.	Particulate matter or PM.  “Particulate matter or PM” means
particulate matter PM10 and PM2.5 including the condensable fraction.

K.	Sale.  “Sale” means the transfer of ownership or control.

3.	Requirements for the Sale, Installation and Operation of New Outdoor
Wood Boilers and Outdoor Pellet Boilers

A.	Particulate Matter Emission Standards for Outdoor Wood Boilers

(1)	Phase I Particulate Emission Standard for Outdoor Wood Boilers and
Outdoor Pellet Boilers.  No person shall distribute or sell, lease,
import, supply or install an outdoor wood boiler after April 1, 2008 or
an outdoor pellet boiler after April 1, 2009 unless it has been
certified under Section 3(E) to meet a particulate matter emission limit
of 0.60 lbs/MMBtu heat input.  Outdoor wood boilers and outdoor pellet
boilers meeting the Phase I limit must be installed according to the
applicable setback and stack height requirements as defined in Section
3(B) and 3(C) of this Chapter.

(2)	Phase II Particulate Emission Standard for Outdoor Wood Boilers and
Outdoor Pellet Boilers.  No person shall distribute or sell, lease,
import, supply or install an outdoor wood boiler or outdoor pellet
boiler after April 1, 2010 unless it has been certified under Section
3(E) to meet a particulate matter emission limit of 0.32 lbs/MMBtu heat
output.  Outdoor wood boilers and outdoor pellet boilers meeting the
Phase II limit must be installed according to the applicable setback and
stack height requirements as defined in Section 3(B) and 3(C) of this
Chapter.

(3)	Voluntary Technology-forcing Particulate Emission Standard for
Outdoor Wood Boilers.  An outdoor wood boiler meeting a particulate
matter emission limit of 0.06 lbs/MMBtu heat output is not subject to a
setback requirement under this Chapter as long as it meets the stack
height requirements described in Section 3(C)(3) of this Chapter.

B.	Setback Requirements for New Outdoor Wood Boilers and Outdoor Pellet
Boilers

(1)	Outdoor wood boilers and outdoor pellet boilers with particulate
emission limits greater than 0.60 lbs/MMBtu heat input or with no
certification.  No person shall install or allow the installation of any
outdoor wood boiler or outdoor pellet boiler that has been certified to
meet a particulate emission limit greater than 0.60 lbs/MMBtu heat input
or has no certification, determined in accordance with Section 3(E) of
this Chapter, unless the outdoor wood boiler or outdoor pellet boiler is
installed at least 250 feet from the nearest property line or at least
270 feet from the nearest dwelling that is not on the same property as
the outdoor wood boiler or outdoor pellet boiler.

(2)	Outdoor wood boilers and outdoor pellet boilers certified to meet
particulate emission limits of 0.60 lbs/MMBtu heat input.  No person
shall install or allow the installation of any outdoor wood boiler or
outdoor pellet boiler that has been certified to meet a particulate
matter emission limit of 0.60 lbs/MMBtu heat input, determined in
accordance with Section 3(E) of this Chapter, unless the outdoor wood
boiler or outdoor pellet boiler is installed at least 100 feet from the
nearest property line or at least 120 feet from the nearest dwelling
that is not on the same property as the outdoor wood boiler or outdoor
pellet boiler.

(3)	Outdoor wood boilers and outdoor pellet boilers certified to meet
particulate emission limits of 0.32 lbs/MMBtu heat output.  No person
shall install or allow the installation of any outdoor wood boiler or
outdoor pellet boiler that has been certified to meet a particulate
matter emission limit of 0.32 lbs/MMBtu heat output, determined in
accordance with Section 3(E) of this Chapter, unless the outdoor wood
boiler or outdoor pellet boiler is installed at least 50 feet from the
nearest property line or at least 70 feet from the nearest dwelling that
is not on the same property as the outdoor wood boiler or outdoor pellet
boiler.

(4)	Outdoor pellet boilers certified to meet particulate emission limits
of 0.06 lbs/MMBtu heat output.  No person shall install or allow the
installation of any outdoor pellet boiler that has been certified to
meet a particulate matter emission limit of 0.06 lbs/MMBtu heat output,
determined in accordance with Section 3(E) of this Chapter, unless the
outdoor pellet boiler is installed at least 20 feet from the nearest
property line or at least 40 feet from the nearest dwelling that is not
on the same property as the or outdoor pellet boiler.

(5)	Outdoor wood boilers that have been modified to burn pellets.
Outdoor wood boilers that have been modified to burn pellets must meet
the applicable setback specified in Section 3(B) of this Chapter for the
original particulate emission limit certification of the outdoor wood
boiler, determined in accordance with Section 3(E) of this Chapter.

C.	Stack Height Requirements for New Outdoor Wood Boilers and Outdoor
Pellet Boilers

(1)	Outdoor wood boilers and outdoor pellet boilers certified to meet
particulate emissions limits of greater than 0.60 lbs/MMBtu heat input
or with no certification.

(a)	No person shall install or allow the installation of any outdoor
wood boiler or outdoor pellet boiler that has been certified to meet a
particulate emission limit of greater than 0.60 lbs/MMBtu heat input or
has no certification, determined in accordance with Section 3(E) of this
Chapter, unless the outdoor wood boiler or outdoor pellet boiler:

(1)	has an attached stack with a minimum stack height of 10 feet above
ground level; or

(2)	has an attached stack extending two feet higher than the peak of the
roof of the structure being served by the outdoor wood boiler or outdoor
pellet boiler, if an abutting residence is located less than 500 feet
from the outdoor wood boiler or outdoor pellet boiler.

(b)	No person shall operate any outdoor wood boiler or outdoor pellet
boiler, installed after the effective date of this Chapter, that has
been certified to meet a particulate emission limit of greater than 0.60
lbs/MMBtu heat input or with no certification, determined in accordance
with Section 3(E) of this Chapter, if an abutting residence is located
less than 500 feet from the outdoor wood boiler or outdoor pellet
boiler, unless the outdoor wood boiler or outdoor pellet boiler has an
attached stack extending two feet higher than the peak of the roof of
the structure being served by the outdoor wood boiler or outdoor pellet
boiler.

(2)	Outdoor wood boilers and outdoor pellet boilers certified to meet
particulate emission limits of 0.60 lbs/MMBtu heat input.

(a)	No person shall install or allow the installation of any outdoor
wood boiler or outdoor pellet boiler that has been certified to meet a
particulate matter emission limit of 0.60 lbs/MMBtu heat input,
determined in accordance with Section 3(E) of this Chapter, unless the
outdoor wood boiler or outdoor pellet boiler:

(1)	has an attached stack with a minimum stack height of 10 feet above
ground level; or

(2)	has an attached stack extending two feet higher than the peak of the
roof of the structure being served by the outdoor wood boiler or outdoor
pellet boiler, if an abutting residence is located less than 300 feet
from the outdoor wood boiler or outdoor pellet boiler.

(b)	No person shall operate any outdoor wood boiler or outdoor pellet
boiler, installed after the effective date of this Chapter, that has
been certified to meet a particulate emission limit of 0.60 lbs/MMBtu
heat input, determined in accordance with Section 3(E) of this Chapter,
if an abutting residence is located less than 300 feet from the outdoor
wood boiler or outdoor pellet boiler, unless the outdoor wood boiler or
outdoor pellet boiler has an attached stack extending two feet higher
than the peak of the roof of the structure being served by the outdoor
wood boiler or outdoor pellet boiler.

(3)	Outdoor wood boilers and outdoor pellet boilers certified to meet
particulate emission limits of 0.32 lbs/MMBtu heat output.

(a)	No person shall install or allow the installation of any outdoor
wood boiler or outdoor pellet boiler that has been certified to meet a
particulate matter emission limit of 0.32 lbs/MMBtu heat output,
determined in accordance with Section 3(E) of this Chapter, unless the
outdoor wood boiler or outdoor pellet boiler:

(1)	has an attached stack with a minimum stack height of 10 feet above
ground level; or

(2)	has an attached stack extending two feet higher than the peak of the
roof of the structure being served by the outdoor wood boiler or outdoor
pellet boiler, if an abutting residence is located less than 300 feet
from the outdoor wood boiler or outdoor pellet boiler.

(b)	No person shall operate any outdoor wood boiler or outdoor pellet
boiler, installed after the effective date of this Chapter, that has
been certified to meet a particulate emission limit of 0.32 lbs/MMBtu
heat output, determined in accordance with Section 3(E) of this Chapter,
if an abutting residence is located less than 300 feet from the outdoor
wood boiler or outdoor pellet boiler, unless the outdoor wood boiler or
outdoor pellet boiler has an attached stack extending two feet higher
than the peak of the roof of the structure being served by the outdoor
wood boiler or outdoor pellet boiler.

(4)	Outdoor pellet boilers certified to meet particulate emission limits
of 0.06 lbs/MMBtu heat output.

(a)	No person shall install or allow the installation of any outdoor
pellet boiler that has been certified to meet a particulate matter
emission limit of 0.06 lbs/MMBtu heat output, determined in accordance
with Section 3(E) of this Chapter, unless the outdoor pellet boiler:

(1)	has an attached stack with a minimum stack height of 10 feet above
ground level; or

(2)	has an attached stack extending two feet higher than the peak of the
roof of the structure being served by the outdoor pellet boiler, if an
abutting residence is located less than 100 feet from the outdoor pellet
boiler.

(b)	No person shall operate any outdoor pellet boiler, installed after
the effective date of this Chapter, that has been certified to meet a
particulate emission limit of 0.06 lbs/MMBtu heat output, determined in
accordance with Section 3(E) of this Chapter, if an abutting residence
is located less than 100 feet from the outdoor pellet boiler, unless the
outdoor pellet boiler has an attached stack extending two feet higher
than the peak of the roof of the structure being served by the outdoor
pellet boiler.

(5)	Outdoor wood boilers that have been modified to burn pellets.
Outdoor wood boilers that have been modified to burn pellets must meet
the applicable stack height specified in Section 3(C) of this Chapter
for the original particulate emission limit certification of the outdoor
wood boiler, determined in accordance with Section 3(E) of this Chapter.

(6)	In the case that there is no structure (e.g. swimming pool or hot
tub) being served by an outdoor wood boiler or outdoor pellet boiler
subject to Section 3(C), the owner or operator of the outdoor wood
boiler or outdoor pellet boiler shall extend the stack two feet higher
than the peak of the roof of the nearest building to the outdoor wood
boiler or outdoor pellet boiler.

D.	Commercial Outdoor Wood Boiler, Commercial Outdoor Pellet Boiler,
Outdoor Wood Boiler or Outdoor Pellet Boiler with a rated thermal output
greater than 350,000 Btu/hr Analysis Requirement

(1)	Any person intending to install or operate a commercial outdoor wood
boiler, commercial outdoor pellet boiler, an outdoor wood boiler, or
outdoor pellet boiler with a rated thermal output greater than 350,000
Btu/hr shall obtain an evaluation, report and installation
recommendations performed by a qualified professional, including a
licensed professional engineer or a master solid fuel burner technician,
that includes the following information:

(a)	What type of application will the outdoor wood boiler or outdoor
pellet boiler be used for;

A determination of the heat load requirements of the facility as
compared to the available heat supply of the outdoor wood boiler or
outdoor pellet boiler to ensure the unit is properly sized;

The stack location relative to the property lines and building locations
within 400 feet of the outdoor wood boiler or outdoor pellet boiler;

The stack height; and

Recommendations for the proper outdoor wood boiler or outdoor pellet
boiler installation, including but not limited to, hook-up, auxiliary
fuel, properly sized outdoor wood boiler or outdoor pellet boiler, stack
height and stack location.

(2)	No person shall install or operate a commercial outdoor wood boiler,
commercial outdoor pellet boiler, outdoor wood boiler or outdoor pellet
boiler with a rated thermal output greater than 350,000 Btu/hr unless it
is installed according to the recommendations of the evaluation report
in Section 3(D)(1).  In any case, no person shall install or operate a
commercial outdoor wood boiler, commercial outdoor pellet boiler, an
outdoor wood boiler or outdoor pellet boiler with a rated thermal output
greater than 350,000 Btu/hr unless it meets the minimum setback and
stack height requirements stated in Section 3(B) and 3(C) of this
Chapter.

E.	Certification of Outdoor Wood Boilers and Outdoor Pellet Boilers.  No
person shall supply, distribute, sell, lease, offer for sale, or allow
the installation of an outdoor wood boiler or an outdoor pellet boiler
in the State of Maine unless the outdoor wood boiler or outdoor pellet
boiler has received certification pursuant to the EPA Outdoor Wood-Fired
Hydronic Heater Program.  The certification shall demonstrate that the
outdoor wood boiler or outdoor pellet boiler meets the applicable
particulate emission standard in Section 3(A) of this Chapter.  The
manufacturer of any such outdoor wood boiler or outdoor pellet boiler
shall conduct testing via the EPA Outdoor Wood-Fired Hydronic Heater
Phase I Program until EPA replaces the EPA Outdoor Wood-Fired Hydronic
Heater Phase I Program with the Environmental Technology Verification
Program.  The Department may approve an alternative certification
program.

F.	Sell-through exemption for Outdoor Wood Boilers.  No person shall
sell or offer for sale any outdoor wood boiler with a particulate
emission rate greater than 0.60 lbs/MMBtu heat input as certified in
accordance with Section 3(E) of this Chapter unless the outdoor wood
boiler was purchased, paid for in full and received in the State of
Maine before April 1, 2008 and the outdoor wood boiler meets all of the
applicable requirements of this Chapter.  Compliance with this Section
must be demonstrated by keeping records of the purchase date and receipt
date of their inventory as of the effective date of this Chapter.  These
records shall be kept for at least 5 years and shall be made available
to the Department upon request.  This exemption is effective until April
1, 2009.

G.	Labeling Requirements.  New outdoor wood boilers and outdoor pellet
boilers shall be labeled in accordance with the labeling requirements of
the U.S. Environmental Protection Agency Outdoor Wood-Fired Hydronic
Heater Program.  Requirements of this program are located at
www.epa.gov/woodheaters/index.htm.

H.	Rain Cap Prohibition.	No person shall operate a new outdoor wood
boiler or outdoor pellet boiler using a rain cap unless this device is
required by the manufacturer specifications.

4.	General Provisions and Requirements For All Outdoor Wood Boilers and
Outdoor Pellet Boilers

A.	Prohibited fuels.  No person shall burn any of the following items in
an outdoor wood boiler:

(1)		any wood that does not meet the definition of clean wood;

(2)		garbage;

(3)		tires;

(4)		lawn clippings or yard waste;

(5)		materials containing plastic;

(6)		materials containing rubber;

(7)		waste petroleum products;

(8)		paints and paint thinners;

(9)		chemicals;

(10)	glossy or colored papers;

(11)	construction and demolition debris;

(12)	plywood;

(13)	particleboard;

(14)	salt water driftwood and other previously salt-water saturated
materials;

(15)	manure;

(16)	animal carcasses;

(17)	asphalt products;

(18)	materials containing asbestos;

(19)	materials containing lead, mercury, or other heavy or toxic metals;
and

(20)	coal, unless the outdoor wood boiler is specifically designed to
burn coal.

B.	Fuel Requirements

(1)	No person that operates an outdoor wood boiler shall use a fuel
other than the following:

(a)	Clean wood;

(b)	Wood pellets made from clean wood;

(c)	Home heating oil in compliance with the applicable sulfur content
limit, propane or natural gas may be used as starter or supplemental
fuels for dual-fired outdoor wood boilers; and

Other fuels as approved by the Department.

No person that operates an outdoor pellet boiler shall use a fuel other
than the following:

(a)	Wood pellets made from clean wood;

(b)	Corn; and

(c)	Other fuels as approved by the Department.

C.	Visible Emission Standard. No person shall cause or allow the
emission of a smoke plume from any outdoor wood boiler or outdoor pellet
boiler to exceed an average of 30 percent opacity on a six minute block
average basis, except for no more than two six minute block averages in
a 3-hour period.  Opacity under this subsection shall be determined
pursuant to EPA Method 9 Visual Determination of the Opacity of
Emissions from Stationary Sources (40CFR60, Appendix A).

D.	Enforcement and Preemption.  This rule is subject to enforcement
pursuant to 38 MRSA §347-A.  Nothing in Chapter 150 may be construed as
pre-empting any otherwise applicable, statute, regulation, local
ordinance or otherwise applicable private common law cause of action.

E.	Notice to Buyers

(1)	No outdoor wood boiler or outdoor pellet boiler subject to the
requirements of this Chapter shall be offered, sold, offered for retail
sale, or leased within the State of Maine unless prior to any sales or
lease agreement, the seller or dealer provides the prospective buyer or
lessee with a copy of this Chapter and a written notice that:

(a)	It is unlawful to burn garbage, treated or painted wood, plastic and
plastic products, rubber products, yard waste, lawn clippings, glossy or
colored papers, construction and demolition debris, materials containing
asbestos, materials containing lead, mercury, or other heavy or toxic
metals, plywood, particleboard, salt water driftwood and other
previously salt water saturated materials, manure, animal carcasses,
asphalt products, coal, unless the outdoor wood boiler is specifically
designed to burn coal, waste petroleum products, paints, chemicals or
any substance that normally emits dense smoke or obnoxious odors;

(b)	Installation of an outdoor wood boiler or outdoor pellet boiler may
be subject to other applicable State and local stack height and setback
requirements;

(c)	The applicable distance and stack height requirements provided in
Section 3(B) and 3(C) of this Chapter may not be adequate in some areas
due to terrain that could render the operation of an outdoor wood boiler
or outdoor pellet boiler to be a nuisance or public health hazard; and

(d)	States the specific results of the average and maximum emission
rates of particulate matter for the outdoor wood boiler or outdoor
pellet in grams per hour per the testing determined in accordance with
Section 3(E) of this Chapter and the average delivered heating
efficiency as found in the test reports that were used for certification
of the units or a statement that the outdoor wood boiler or outdoor
pellet boiler has not been tested or certified.

(2)	The written notice specified above shall be signed by the buyer or
lessee at the time of purchase or lease to indicate receipt of notice.
Said notice shall contain the names; addresses; telephone number of both
the seller or dealer and the buyer or lessee; the location where the
outdoor wood boiler or outdoor pellet boiler will be installed; and the
make and model of the outdoor wood boiler or outdoor pellet boiler.  The
dealer shall keep these records for 5 years and provide them to the
Department upon request.

F.	Owner’s Manual.  Each outdoor wood boiler or outdoor pellet boiler
offered for sale or lease must be accompanied by an owner’s manual
that shall contain all the information listed below:

(1)	Thermal output capacity;

(2)	Proper installation information;

(3)	Operation and maintenance information to minimize emissions;

(4)	Wood loading procedures, recommendations on wood selection, and
warnings on improper fuels;

(5)	Fire starting procedures;

(6)	Proper use of air flow devices, if applicable;

(7)	Ash removal procedures;

(8)	For catalytic models, information pertaining to maintaining catalyst
performance, maintenance procedures, procedures for determining catalyst
failure or deterioration, procedures replacement, and information on
warranty rights.

(9)	Language stating: Improper use or failure to maintain the outdoor
wood boiler or outdoor pellet boiler may cause nuisance conditions.
Persons operating this outdoor wood boiler or outdoor pellet boiler are
responsible for operation of the outdoor wood boiler or outdoor pellet
boiler so as not to cause a nuisance condition.  Even proper use and
maintenance of the outdoor wood boiler or outdoor pellet boiler, and
meeting the distance and stack height recommendations and requirements
in State and local regulations may not always be adequate to prevent
nuisance conditions in some areas due to terrain or other factors.

5.	Nuisance Conditions

A.	Standard.  No person shall operate an outdoor wood boiler or an
outdoor pellet boiler, that produces visible emissions, measured as any
opacity totaling twelve minutes in any hour, that cross onto any land or
buildings immediately adjacent to a dwelling or commercial building not
owned by the owner of the outdoor wood boiler.  Opacity under this
subsection shall be determined pursuant to EPA Method 22 Visual
Determination of Fugitive Emissions from Material Sources and Smoke
Emissions from Flares (40CFR60, Appendix A).

B.	Prohibition.  No person shall operate an outdoor wood boiler or an
outdoor pellet boiler, in such a manner as to create a nuisance.

6.	Third Party Sales

As of the effective date of this Chapter, an outdoor wood boiler or
outdoor pellet boiler that has been owned by an individual and was in
use in Maine prior to the effective date of this Chapter may be
distributed or sold to another individual for his or her own personal
use.  The outdoor wood boiler or outdoor pellet boiler shall be subject
to the applicable setback and stack height requirements specified in
Section 3(B) and 3(C).  If the particulate emission limit is not known,
the outdoor wood boiler or outdoor pellet boiler must meet the setback
and stack height requirements of Section 3(B)(1)and 3(C)(1).

7.	Effective date

Unless otherwise noted, compliance with all applicable provisions of
this Chapter is the effective date of the regulation.

Severability

Each Section of this Chapter shall be deemed severable, and in the event
that any Section of this Chapter is held invalid, the remainder shall
continue in full force and effect.

AUTHORITY:	38 M.R.S.A., §585-A, §610-B

EFFECTIVE DATE:	November 9, 2007

    Amended:	July 4, 2008

	April 7, 2009

	April 11, 2010

_________________________________________

BASIS STATEMENT

In 1988 EPA established particulate emission standards for residential
wood stoves sold in the United States after 1992.  However, outdoor wood
boilers (OWB), also known as outdoor wood-fired hydronic heaters (OWHH)
were not included in the EPA residential wood stove regulations and have
not been regulated by EPA or the Department.  OWB, which burn wood to
heat water that is piped underground to a nearby structure (usually a
home) for space heating, are available in a wide variety of sizes and
efficiencies.  OWB, on an average per hour basis, emit about four times
as much fine particulate matter as conventional wood stoves, about 12
times as much fine particulate matter as an EPA-certified wood stove,
and 1000 times more than an oil furnace.

In addition to fine particulates, wood combustion emissions contain
sulfur oxides, nitrogen oxides, carbon monoxide and potentially
cancer-causing compounds including formaldehyde, polycyclic aromatic
hydrocarbons, benzene and dioxins.  Fine particulates can aggravate lung
diseases such as asthma, emphysema and bronchitis.  Children, the
elderly and those with respiratory problems are most at risk from
exposure to wood smoke.

In June 2007, the Maine Legislature enacted LD 1824, An Act To Regulate
Outdoor Wood Boilers.  This legislation established emission standards
for new outdoor wood boilers starting in 2008 and also directed the
Department to adopt rules related to outdoor wood boilers.  “The rules
must include provisions relating to siting, operation and labeling
requirements, stack heights, dealer and manufacturer reporting, public
notification of emission standards and operation and siting
requirements, code enforcement officer training, nuisance conditions and
existing inventory issues.”

Chapter 150 establishes requirements for the sale and installation of
new outdoor wood boilers, including particulate emission standards and
requirements for setback and stack height, certification, sell-through
of existing inventory, and labeling.  The rule also contains general
provisions which apply to all OWB.  These provisions include prohibited
and allowed fuels, visible emissions standards, notice to buyers, and
owner manual requirements.  In addition, pursuant to the new
legislation, for the purpose of this rule, the Department included a
definition of “nuisance” and a method by which a nuisance condition
can be identified.  Pursuant to 38 MRSA Section 610-B, Chapter 150 was
adopted as emergency major substantive rules pursuant to Title 5,
section 8073 and must be submitted to the Legislature for review by
January 15, 2008.

BASIS STATEMENT FOR AMENDMENT OF MAY 15, 2008

In April 2008, the Maine Legislature enacted Resolve Chapter 190,
Regarding Legislative Review of Portions of Chapter 150: Control of
Emissions from Outdoor Wood Boilers, a Major Substantive Rule of the
Department of Environmental Protection, Bureau of Air Quality Control.
This legislation requires amendments to Chapter 150 in several areas: 1)
clarifying that in order to be eligible for the sell-through exemption
contained in the rule the outdoor wood boiler must have been purchased,
paid for in full and in the State of Maine prior to April 1, 2008; 2)
authorizing the optional use of setbacks from neighboring dwellings for
the installation of new outdoor wood boilers; and 3) requiring that
setbacks from state licensed school, daycare or healthcare facilities
conform to the general setback requirements.

BASIS STATEMENT FOR AMENDMENT OF MARCH 19, 2009

In April 2008, the Maine Legislature enacted Resolve 2007, Chapter 190,
Regarding Legislative Review of Portions of Chapter 150: Control of
Emissions from Outdoor Wood Boilers, a Major Substantive Rule of the
Department of Environmental Protection, Bureau of Air Quality Control.
This legislation requires the Board of Environmental Protection to adopt
rules by April 1, 2009 to control the sale, installation, use and siting
at residences and businesses of outdoor wood boilers that combust
biomass pellets as a fuel source.

BASIS STATEMENT FOR AMENDMENT OF MARCH 18, 2010

In May 2009, the Maine Legislature enacted Public Law, Chapter 209 LD
1171, An Act to Amend the Laws Governing Outdoor Wood Boilers, which
became effective September 12, 2009.  This legislation directs the
Department to amend the definition of commercial outdoor wood boiler,
establish a voluntary technology-forcing particulate emission limit,
amend the definition of outdoor wood boiler and change the
qualifications for those who prepare an evaluation, report and
installation recommendations for commercial outdoor wood boilers and
larger outdoor wood boilers.

In addition to the basis statement above, the Department has filed with
the Secretary of State a response to comments received during the
comment period.

 PAGE

DEPARTMENT OF ENVIRONMENTAL PROTECTION

________________________________________________________________________
______

Chapter 150: Control of Emissions from Outdoor Wood Boilers

  PAGE  12


[Federal Register: March 17, 2010 (Volume 75, Number 51)]
[Notices]
[Page 12767]
[DOCID:fr17mr10-86]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Joint Meeting of the Anesthetic and Life Support Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory Committee;
Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committees: Anesthetic and Life Support Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory Committee.
    General Function of the Committees: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on April 22, 2010, from 8
a.m. to 4:30 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms,
620 Perry Pkwy., Gaithersburg, MD. The hotel phone number is 301-977-
8900.
    Contact Person: Kalyani Bhatt, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-7001, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>or
FDA Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER>
in Washington, DC area), codes<PHONE_NUMBER> and<PHONE_NUMBER>. Please call
the Information Line for up-to-date information on this meeting. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hotline/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On April 22, 2010, the committees will discuss new drug
application (NDA) 22-451 ACUROX (oxycodone HCl and niacin) Tablets,
Acura Pharmaceuticals, Inc., for the proposed indication of relief of
moderate to severe pain where the use of an immediate-release, orally
administered, opioid analgesic tablet is appropriate, and the results
of studies evaluating the addition of niacin, added for the purpose of
reducing the misuse of oxycodone.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
April 15, 2010. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those desiring to make formal
oral presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before April 7, 2010. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by April 8,
2010.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Kalyani Bhatt at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: March 11, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-5815 Filed 3-16-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: December 21, 2009 (Volume 74, Number 243)]
[Notices]
[Page 67877-67878]
[DOCID:fr21de09-41]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0588]

Guidance for Industry on the Timeframe for Submission of Tobacco
Health Documents; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Timeframe for Submission of
Tobacco Health Documents.'' This document provides written guidance to
tobacco product manufacturers and importers on enforcement of the
requirement to submit certain documents to FDA under the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act).

DATES: The guidance is final upon the date of publication. However, you
may submit electronic or written comments on the guidance at any time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Timeframe for Submission of Tobacco Health
Documents'' to the Center for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. Send
one self-addressed adhesive label to assist that office in processing
your request or include a fax number to which the guidance document may
be sent. See the SUPPLEMENTARY INFORMATION section for information on

electronic access to the guidance document.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments on the guidance to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Identify comments with the docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Michele Mital, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850-3229,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the President signed the Tobacco Control Act
(Public Law 111-31) into law. The Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq.)
by adding a new chapter granting FDA important new authority to
regulate the manufacture, marketing, and distribution of tobacco
products to protect the public health generally and to reduce tobacco
use by minors.
    Section 904(a)(4) of the act requires each tobacco product
manufacturer or importer, or agent thereof, to submit all documents
developed after June 22, 2009, ``that relate to health, toxicological,
behavioral, or physiologic effects of current or future tobacco
products, their constituents (including smoke constituents),
ingredients, components, and additives.'' Information required under
section 904(a)(4) of the act must be submitted to FDA beginning
December 22, 2009. FDA recognizes the challenges associated with the
collection, review, organization, and production of documents. We also
recognize that additional time may be necessary for the production of
documents in a digital format, which FDA strongly encourages in order
to improve the management and readability of submitted documents.
Therefore, FDA does not intend to enforce the December 22, 2009,
initial document submission deadline, provided that manufacturers and
importers submit by April 30, 2010, all documents described in section
904(a)(4) of the act developed between June 23, 2009, and March 31,
2010. FDA is in the process of developing a draft guidance document
that will explain the requirements of and recommendations for
compliance with section 904(a)(4) of the act. We anticipate that the
draft guidance document will be issued shortly.

II. Significance of Guidance

    FDA is issuing this guidance document as a level 1 guidance
consistent with FDA's good guidance practices regulation (Sec.  10.115
(21 CFR 10.115)). This guidance document is being implemented
immediately without prior public comment, under Sec.  10.115(g)(2),
because the agency has determined that prior public participation is
not feasible or appropriate. This document provides guidance on
statutory requirements that are due to take effect on December 22,
2009, and so it is urgent that FDA explain its enforcement policy
before that date.

III. Comments

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

IV. Electronic Access

    An electronic version of the guidance document is available on the
Internet at http://www.regulations.gov and http://www.fda.gov/
TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: December 16, 2009.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning, and Budget.
[FR Doc. E9-30297 Filed 12-16-09; 4:15 pm]

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