  SEQ CHAPTER \h \r 1 			ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2006-0280; FRL-       ]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania;

VOC and NOx RACT Determinations for Five Individual Sources

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

SUMMARY:  EPA is taking final action to approve revisions to the
Commonwealth of Pennsylvania State Implementation Plan (SIP).  The
revisions were submitted by the Pennsylvania Department of Environmental
Protection (PADEP) to establish and require reasonably available control
technology (RACT) for five major sources of volatile organic compounds
(VOC) and nitrogen oxides (NOx) pursuant to the Commonwealth of
Pennsylvania’s (Pennsylvania’s or the Commonwealth’s) SIP-approved
generic RACT regulations.  EPA is approving these revisions in
accordance with the Clean Air Act (CAA).

EFFECTIVE DATE:  This final rule is effective on [insert date 30 days
from date of publication].

ADDRESSES:  EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2006-0280.  All documents in the docket are listed in
the     HYPERLINK "http://www.regulations.gov"  www.regulations.gov
website.  Although listed in the electronic docket, some information is
not publicly available, i.e., confidential business information (CBI) or
other information whose disclosure is restricted by statute.  Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
through     HYPERLINK "http://www.regulations.gov"  www.regulations.gov
or in hard copy for public inspection during normal business hours at
the Air Protection Division, U.S. Environmental Protection Agency,
Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.  Copies
of the State submittal are available at the Pennsylvania Department of
Environmental Protection, Bureau of Air Quality, P.O. Box 8468, 400
Market Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT:   Rose Quinto,<PHONE_NUMBER>, or by
e-mail at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

SUPPLEMENTARY INFORMATION:

I.  Background

On May 4, 2006 (71 FR 26297), EPA published a notice of proposed
rulemaking (NPR) for the Commonwealth of Pennsylvania.  The NPR proposed
approval of the SIP revisions submitted by PADEP on February 4, 2003 and
November 21, 2005.  These SIP revisions consisted of seven
source-specific operating permits issued by PADEP to establish and
require RACT pursuant to the Commonwealth’s SIP-approved generic RACT
regulations.  The following table identifies five of those sources and
the individual operating permits (OPs) which are the subject of this
rulemaking.

We are taking final action on these five source-specific RACT rules in
this final action.  We will take final action on the other two
source-specific operating permits in a separate action.

PENNSYLVANIA - VOC AND NOx RACT DETERMINATIONS FOR INDIVIDUAL SOURCES

SOURCE’S

NAME	COUNTY	Operating Permit

(OP #)	SOURCE TYPE	“MAJOR SOURCE”

POLLUTANT

  SEQ CHAPTER \h \r 1 Armstrong World Industries, Inc.	Lancaster	36-2002
Sheet and Flooring Products Manufacturer	VOC and NOx

Peoples Natural Gas Company	Clarion	16-124	Natural Gas Compressor	VOC
and NOx

Dart Container Corporation	Lancaster	36-2015	Expanded Polystyrene
Manufacturing Facility	VOC and NOx

AT&T Microelectronics	Lehigh	39-0001	Semiconductors Manufacturing	VOC
and NOx

West Penn Power Co.	Greene 	30-000-099	Power Plant	VOC and NOx

An explanation of the CAA’s RACT requirements as they apply to the
Commonwealth and EPA’s rationale for approving these SIP revisions
were provided in the NPR and will not be restated here.

Timely adverse comments were submitted on EPA(s May 4, 2006 NPR.  A
summary of those comments and EPA(s responses are provided in Section II
of this document.

  SEQ CHAPTER \h \r 1

II.  Summary of Public Comments and EPA Responses

On June 5, 2006, EPA received adverse comments on EPA’s May 4, 2006
NPR proposing approval of PADEP’s VOC and NOx RACT determinations for
seven individual sources.  The comments addressed only three of the
seven individual sources; namely, The Frog, Switch & Manufacturing
Company (The Frog); Merck & Co. Inc. (Merck); and Dart Container
Corporation (Dart).  EPA received no comments on the RACT determinations
for the other four sources.  We respond to the comments for Dart in this
notice.  We will respond to the comments regarding the Frog and Merck in
a separate final action on the source-specific rules for those two
sources.

Comment:  With respect to Dart, the comment asserts that the RACT
determination does not address an estimated 30 tons per year of VOC
emissions from “cleaning solvents.”

Response:  The commenter is mistaken.  Condition 6 of the RACT
determination limits total annual pentane emissions from the foam cup
molding plants to 615 tons.  As explained in the publicly available
supporting material submitted with the SIP revision by PADEP, the 615
tons of VOCs (primarily pentane), includes the approximately 30 tons per
year of “cleaning supply losses” (not, as the commenter mistakenly
categorizes them, “cleaning solvents”).

Comment:  With respect to Dart, the commenter asserts that the current
control of the pre-expanders should be included in the RACT
determination as a RACT requirement.

Response:  Current control of the pre-expanders is a requirement of the
RACT determination.  Condition 5 of the RACT determination states that
“RACT for VOC emissions from all sources at this facility is
determined to be current operations.”  “[A]ll sources” would
include the pre-expanders.

Comment:  With respect to Dart, the commenter proposes a control
technology (use of a concentrator in series with an oxidation control
device) to be evaluated for control of dilute VOC gas streams from the
cup production plants.

Response:   The comment implies that the RACT analysis with respect to
the VOC controls for the cup production plants was not correctly
performed.  Although the commenter asserts that the RACT determination
is incorrect because the RACT analysis did not consider the
commenter’s proposed control technology, the commenter does not
provide information that this control technology meets the criteria for
consideration as potential RACT as specified by the Pennsylvania generic
RACT regulation.  The Pennsylvania generic RACT regulation specifies
that the only control options that need to be considered are those that
meet the threshold criterion of having “a reasonable potential for
application to the source.”  25 Pa. Code 129.92(b)(1).  In the single
conclusory sentence regarding this technology in the comment, the
commenter does not provide any information from which EPA could evaluate
the claim that such technology should have been considered as RACT.  The
commenter does not provide sufficient information from which EPA can
discern whether  - such a “concentrator in series with an oxidation
control device” is even a currently extant technology (the RACT
analysis concluded that “UV oxidizers/Photoxidation” were not among
the technologies that have been successful at controlling the VOC –
the pentane – emitted from this facility, but it is unclear if this
type of “oxidation control device” intended by the commenter, as
other processes, such as incineration, may also be properly referred to
as “oxidation”).  Furthermore,  the commenter provides no supporting
technical data or information to indicate that the “current
operations” specified as RACT for all sources at the facility (which
would include sources of dilute VOC gas streams from the cup production
processes), is not RACT, or alternatively, that the proposed control
technology may be RACT.  Furthermore, the comment does not identify
which gas streams it considers to be sources of “dilute VOC” gas
streams to which the commenter would apply the control technology.

Additionally, the supporting document submitted by PADEP with the SIP
revision for the RACT determination extensively discusses the technical
feasibility and cost effectiveness of various control technologies,
including oxidation and concentration technologies for the capture and
destruction of VOC from various sources at the facility, prior to
concluding that current operations (which do not include oxidation and
concentration) are RACT.  Due to the lack of specificity of the comment,
EPA believes it is possible that the technology proposed by the
commenter may actually be among the options considered and rejected in
the RACT analysis, which lists “concentration technologies in
conjunction with incineration” as a “proven success” for
controlling pentane emissions.  However, the RACT analysis did not
conclude that this technology would be cost effective.

In sum, the commenter merely asserts in a single sentence, without
support, that there is a technology that ought to have been considered
(and which may actually have been considered), but has not provided EPA
with sufficient information for us to determine what that technology is
and  evaluate whether it meets even the relatively lax standard of 25
Pa. Code 129.92(b)(1), of having a “reasonable potential” to be
applied to this source.  The mere assertion that an agency may have
gotten something wrong without the commenter providing a basis for
evaluating that assertion, does not rise to level of a relevant comment
warranting a substantive response.  See International Fabricare Inst. v.
EPA, at 391.  See also Whitman v. American Trucking Associations, Inc.,
n.2. at 471.

EPA therefore may approve the RACT determinations for the four sources
in which we received no adverse comment, and for Dart in this
rulemaking.

III.  Final Action

EPA is approving the revisions to the Pennsylvania SIP submitted by
PADEP on February 4, 2003 and November 21, 2005, to establish and
require VOC and NOx RACT for five sources pursuant to the
Commonwealth’s SIP-approved generic RACT regulations.

IV.  Statutory and Executive Order Reviews

A.  General Requirements

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action
is not a "significant regulatory action" and therefore is not subject to
review by the Office of Management and Budget.  For this reason, this
action is also not subject to Executive Order 13211, "Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use" (66 FR 28355, May 22, 2001).  This action merely approves state law
as meeting Federal requirements and imposes no additional requirements
beyond those imposed by state law.  Accordingly, the Administrator
certifies that this rule will not have a significant economic impact on
a substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.).  Because this rule approves pre-existing
requirements under state law and does not impose any additional
enforceable duty beyond that required by state law, it does not contain
any unfunded mandate or significantly or uniquely affect small
governments, as described in the Unfunded Mandates Reform Act of 1995
(Public Law 104-4).  This rule also does not have tribal implications
because it will not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).  This action also
does not have Federalism implications because it does not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999).  This
action merely approves a state rule implementing a Federal standard, and
does not alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act.  This rule also is
not subject to Executive Order 13045 “Protection of Children from
Environmental Health Risks and Safety Risks” (62 FR 19885, April 23,
1997), because it approves a state rule implementing a Federal Standard.

In reviewing SIP submissions, EPA’s role is to approve state choices,
provided that they meet the criteria of the Clean Air Act.  In this
context, in the absence of a prior existing requirement for the State to
use voluntary consensus standards (VCS), EPA has no authority to
disapprove a SIP submission for failure to use VCS.  It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act.  Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (15 U.S.C. 272 note) do not apply.  This rule does not impose an
information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

B.  Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating the
rule must submit a rule report, which includes a copy of the rule, to
each House of the Congress and to the Comptroller General of the United
States.  Section 804 exempts from section 801 the following types of
rules: (1) rules of particular applicability; (2) rules relating to
agency management or personnel; and (3) rules of agency organization,
procedure, or practice that do not substantially affect the rights or
obligations of non-agency parties.  5 U.S.C. 804(3).  EPA is not
required to submit a rule report regarding today’s action under
section 801 because this is a rule of particular applicability
establishing source-specific requirements for five named sources.

C.  Petitions for Judicial Review

Under section 307(b)(1) of the Clean Air Act, petitions for judicial
review of this action must be filed in the United States Court of
Appeals for the appropriate circuit by [insert date 60 days from date of
publication of this document in the Federal Register].  Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action.

This action, approving source-specific RACT requirements for five
sources in the Commonwealth of Pennsylvania, may not be challenged later
in proceedings to enforce its requirements.  (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements, Volatile organic
compounds.

May 30, 2007

_________________
__________________________

Dated:            				                        William T. Wisniewski,

                                      				Acting Regional Administrator,

                                      				Region III.

40 CFR part 52 is amended as follows:

PART 52 - [AMENDED]

1.  The authority citation for part 52 continues to read as follows:

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

Subpart NN– Pennsylvania

2.  In § 52.2020, the table in paragraph (d)(1) is amended by adding
the entries for   SEQ CHAPTER \h \r 1 Armstrong World Industries, Inc.;
Peoples Natural Gas Company; Dart Container Corporation; AT&T
Microelectronics; and West Penn Power Co. at the end of the table to
read as follows:

§ 52.2020  		Identification of plan.

*		*		*		*		*

(d)  *   *   *

(1)  *   *   *

Name of source	Permit

number	County	State effective date	EPA approval date	Additional
explanation/

§ 52.2063 citation

     *     *     *     *     *     *     *

  SEQ CHAPTER \h \r 1 Armstrong World Industries, Inc.	Lancaster	OP
36-2002	10/31/96	[Insert Federal Register publication date]

[Insert page number where the document begins]	52.2020(d)(1)(u)

	Peoples Natural Gas Company	Clarion	OP 16-124	8/11/99	[Insert Federal
Register publication date]

[Insert page number where the document begins]	52.2020(d)(1)(u)

Dart Container Corporation	Lancaster	OP 36-2015	8/31/95	[Insert Federal
Register publication date]

[Insert page number where the document begins]	52.2020(d)(1)(u)

AT&T Microelectronics	Lehigh	OP 39-0001	5/19/95	Insert Federal Register
publication date]

[Insert page number where the document begins]	52.2020(d)(1)(u)

West Penn Power Co.	Greene 	OP 30-000-099	5/17/99	Insert Federal
Register publication date]

[Insert page number where the document begins]	52.2020(d)(1)(u)

*		*		*		*		*

 PAGE

  PAGE   10

  PAGE   12


[Federal Register Volume 86, Number 133 (Thursday, July 15, 2021)]
[Notices]
[Pages 37319-37320]
[FR Doc No: 2021-15095]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP21-958-000.
    Applicants: NRG Power Marketing LLC, Middletown Power LLC,
Generation Bridge Acquisition, LLC.
    Description: Joint Petition for Limited Waiver of Capacity Release
Regulations, et al. of NRG Power Marketing LLC, et al. under RP21-958.
    Filed Date: 7/6/21.
    Accession Number: 20210706-5155.
    Comments Due: 5 p.m. ET 7/19/21.

    Docket Numbers: RP21-959-000.
    Applicants: NRG Power Marketing LLC, Direct Energy Business
Marketing, LLC, Generation Bridge Acquisition, LLC.
    Description: Joint Petition for Limited Waiver of Capacity Release
Regulations, et al. of NRG Power Marketing LLC, et al. under RP21-959.
    Filed Date: 7/6/21.
    Accession Number: 20210706-5156.
    Comments Due: 5 p.m. ET 7/19/21.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 9, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-15095 Filed 7-14-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 176 (Wednesday, September 13, 2017)]
[Proposed Rules]
[Pages 42963-42968]
[FR Doc No: 2017-19434]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 112

[Docket No. FDA-2011-N-0921]
RIN 0910-ZA50

Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption; Extension of Compliance Dates for
Subpart E

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing to extend, for covered produce other than sprouts, the dates
for compliance with the agricultural water provisions in the Standards
for the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption rule. We are proposing to extend the compliance dates to
address questions about the practical implementation of compliance with
certain provisions and to consider how we might further reduce the
regulatory burden or increase flexibility while continuing to achieve
our regulatory objectives, in keeping with the Administration's
policies.

DATES: Submit either electronic or written comments on this proposed
rule by November 13, 2017.

ADDRESSES: You may submit comments on the extension of the compliance
period as follows. Please note that late, untimely filed comments will
not be considered. Electronic comments must be submitted on or before
November 13, 2017. The https://www.regulations.gov electronic filing
system will accept comments until midnight Eastern Time at the end of
November 13, 2017. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and

identified, as confidential, if submitted as detailed in
``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-N-0921 for ``Standards for the Growing, Harvesting, Packing,
and Holding of Produce for Human Consumption; Extension of Compliance
Dates for Subpart E.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

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

SUPPLEMENTARY INFORMATION:

I. Background

    This proposed extension of compliance dates concerns one of the
seven foundational rules that we have established in Title 21 of the
Code of Federal Regulations (21 CFR) as part of our implementation of
the FDA Food Safety Modernization Act (FSMA; Pub. L. 111-353):
``Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption'' (the produce safety regulation,
published in the Federal Register of November 27, 2015, 80 FR 74354)
(https://www.fda.gov/fsma).
    In the preamble of the final rule establishing the produce safety
regulation, we stated that the produce safety regulation would be
effective on January 26, 2016, and provided for compliance dates of 1
to 6 years from the effective date depending on farm size, commodity,
and provision(s) (see table entitled ``compliance dates'' in the
preamble of the final rule establishing the produce safety regulation,
80 FR 74354 at 74357, as corrected in a technical amendment at 81 FR
26466, May 3, 2016). (Some of the compliance dates identified in the
technical amendment fall on weekends (i.e., January 26, 2019, is a
Saturday and January 26, 2020, is a Sunday) and should therefore be
read as referring to the next business day (i.e., January 28, 2019, and
January 27, 2020, respectively). We use the latter dates throughout
this document.)
    For the majority of agricultural water provisions at subpart E (and
for most of the other provisions in the rule), with respect to covered
produce other than sprouts, we provided compliance periods of 4 years
from the effective date of the rule for very small businesses, 3 years
for small businesses, and 2 years for all other businesses. We provided
an additional 2 years beyond those compliance periods for certain water
quality requirements in Sec.  112.44 and related provisions in
Sec. Sec.  112.45 and 112.46. See table 1.
    In a final rule, ``The Food and Drug Administration Food Safety
Modernization Act: Extension and Clarification of Compliance Dates for
Certain Provisions of Four Implementing Rules'' (81 FR 57784, August
24, 2016) we also extended the compliance date for certain ``customer
provisions'' in the produce safety regulation (Sec.  112.2(b)(3)) and
clarified the compliance dates for certain agricultural water testing
provisions as originally established in the produce safety regulation.

  Table 1--As Stated in Produce Safety Regulation, Compliance Dates for
  Requirements in Subpart E (Agricultural Water) for Covered Activities
     Involving Covered Produce (Except Sprouts Subject to Subpart M)
------------------------------------------------------------------------
                                           Extended compliance date of
     Compliance dates of 2-4 years        additional 2 years beyond the
  applicable to the farm based on its     compliance date based on size
                  size                               of farm
------------------------------------------------------------------------
Sec.   112.41..........................  Sec.   112.44.
Sec.   112.42..........................  Sec.   112.45(a) with respect
                                          to Sec.   112.44(a) criterion.
Sec.   112.43..........................  Sec.   112.45(b).
Sec.   112.45(a) with respect to safe    Sec.   112.46(b)(1) with
 and adequate standard.                   respect to untreated ground
                                          water.
Sec.   112.46(a).......................  Sec.   112.46(b)(2) and (b)(3).
Sec.   112.46(b)(1) with respect to      112.46(c).
 untreated surface water.
Sec.   112.47..........................
Sec.   112.48..........................
Sec.   112.49..........................
Sec.   112.50..........................
------------------------------------------------------------------------

II. Proposed Extension of Subpart E Compliance Dates for Produce Other
Than Sprouts

    FDA has received feedback from numerous stakeholders raising issues
regarding the practicality of some of the agricultural water
requirements in the produce safety regulation as applied to covered
produce other than sprouts. Many of these concerns relate to the
testing requirements for pre-harvest agricultural water, which are
different for sprouts than they are for other types of covered produce.
We are proposing this extension in light of the feedback we have
received and under Executive Orders 13777, 13771, and 13563. Additional
time would allow us to consider approaches to address these issues, as
well as opportunities there may be to reduce the cost and enhance the
flexibility of these requirements beyond those reflected in the final
rule.
    As part of this proposed extension, we also propose to simplify the
subpart E compliance period structure such that all the compliance
dates for subpart E provisions as applied to non-sprout produce would
occur at the same time, retaining date staggering based on farm size.
Accordingly, covered farms would have 2 years beyond the previously
published compliance dates for the water quality requirements in Sec.
112.44 and related provisions in Sec. Sec.  112.45 and 112.46, to
comply with all of subpart E. Put another way, we propose to extend the
compliance dates for provisions in the first column of table 1 by 4
years, and propose to extend the compliance dates for provisions in the
second column of table 1 by 2 years, so that the compliance dates for
non-sprout covered produce for all provisions of subpart E would be
those in table 2.

  Table 2--Proposed Compliance Dates for Requirements in Subpart E for
 Covered Activities Involving Covered Produce (Except Sprouts Subject to
                               Subpart M)
------------------------------------------------------------------------
                                 Proposed time periods starting from the
                                effective date of the November 27, 2015,
                                 produce safety final rule (January 26,
     Size of covered farm                         2016)
                               -----------------------------------------
                                Compliance period     Compliance date
------------------------------------------------------------------------
Very Small Business...........  8 years..........  January 26, 2024.
Small Business................  7 years..........  January 26, 2023.
All Other Businesses..........  6 years..........  January 26, 2022.
------------------------------------------------------------------------

    We believe the simpler compliance date structure would alleviate
confusion, and because we are proposing it as part of a proposal to
provide additional time for compliance with all of the provisions, we
expect it to alleviate burden. We do not anticipate that the change
would result in any practical or logistical compliance challenges. We
request comment on whether this change to the compliance date structure
would be helpful.
    This proposed rule is limited in scope to extending the compliance
dates for covered produce other than sprouts. The proposed rule does
not address the underlying requirements in subpart E, but only the
compliance dates for those requirements (for covered produce other than
sprouts). We will continue to work with stakeholders on the issues
raised regarding the agricultural water requirements.
    Our goal is to complete this rulemaking as quickly as possible.
However, we are aware that many farms have been working well in advance
of their compliance dates to come into compliance. As we continue to
work with stakeholders on issues raised regarding the agricultural
water requirements, we intend to exercise enforcement discretion for
covered produce other than sprouts relative to the agricultural water
provisions in subpart E of the produce safety regulation. This means
that while we are considering these issues, we do not intend to enforce
the requirements in subpart E of the regulation for covered produce
other than sprouts. Thus, by announcing we intend to exercise
enforcement discretion for covered produce other than sprouts relative
to the agricultural water provisions in subpart E, farms may choose to
continue with their current water testing programs or allocate their
resources differently to avoid incurring additional costs based on our
proposal to extend the agricultural water compliance dates. And, as
explained above, when we finalize compliance dates, we intend to
continue to work with stakeholders to address agricultural water
questions and with farms to prepare for compliance.
    This proposed rule also would not change the compliance dates for
sprouts. In the final produce safety regulation, we provided staggered
compliance periods based on farm size for covered activities involving
sprouts. The compliance date for activities involving sprouts for very
small businesses is January 28, 2019. The compliance date for
activities involving sprouts for small businesses is January 26, 2018.
The compliance date for activities involving sprouts for all other
businesses is January 26, 2017. Because sprouts present a unique safety
risk, the final produce safety regulation established sprout-specific
requirements on multiple topics, including agricultural water. The
agricultural water requirements for sprouts are different from the
agricultural water requirements for other produce commodities (compare
Sec. Sec.  112.44(a)(1) and 112.44(b)). Moreover, based on the
information available to us, many sprout farms use municipal water for
growing activities; and under the produce safety regulation, covered
farms are not required to test water from a public supply when certain
conditions are met (see 21 CFR 112.46(a)(1) and (2)). We also
established earlier compliance dates for sprouts than for other covered
produce, and the first compliance date for covered sprout farms
(January 26, 2017) has already passed. We have not received any
significant feedback from sprout farms that subpart E has posed
particular challenges. Accordingly, we are proposing to take no action
with regard to compliance dates for activities involving sprouts and
thus the compliance dates for covered farms with respect to sprouts are
the original compliance dates, including for the agricultural water
provisions in Subpart E.
    Table 3 summarizes the compliance dates for the produce safety
regulation as they would be if this proposed rule is finalized. Time
periods start from effective date of the produce safety rule (January
26, 2016) except as otherwise specified.

[GRAPHIC] [TIFF OMITTED] TP13SE17.001

III. Economic Analysis of Impacts

    We have examined the impacts of this proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4), and Executive Order 13771 on Reducing Regulation and Controlling
Regulatory Costs (January 30, 2017). Executive Orders 12866 and 13563
direct us to assess all costs and benefits of available regulatory
alternatives and, when regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety, and other advantages;
distributive impacts; and equity). Executive Order 13563 states the
importance of quantifying costs and benefits, reducing costs and
burdens, and harmonizing rules. We conclude that this proposed rule
would not increase compliance costs and would instead reduce compliance
costs by delaying certain compliance dates. Moreover, it would serve an
important purpose of providing us an opportunity to consider how to
reduce burdens on the public. We conclude that this proposed rule is an
economically

significant regulatory action as defined by Executive Order 12866.
    This rule would extend, for non-sprout covered produce, the
compliance date for all of the provisions of subpart E to 4 years after
the relevant farm's compliance date for all other provisions of the
produce safety regulation (which varies based on establishment size).
The estimated costs and benefits accrued in any given year of
compliance with the produce safety regulation, relative to the first
year of compliance, would not change. However, because the compliance
dates for certain provisions would be extended, the discounted value of
both total costs and total benefits would decrease.
    There would be a reduction in costs (i.e., cost savings) associated
with extending, for non-sprout covered produce, the compliance date for
all of the provisions of subpart E to 4 years after the relevant farm's
compliance date for the rest of the produce safety regulation. With
respect to their non-sprout covered produce, covered farms would have 4
years from the compliance date for the other provisions of produce
safety regulation to comply with the provisions in subpart E. Thus,
while all initial start-up costs and recurring costs would remain the
same as estimated in the final regulatory impact analysis for the
produce safety regulation (Ref. 1), the annualized total costs,
discounted at 3 percent over 10 years, would decrease by about 3
percent from $404 million to $392 million, resulting in a savings of
$12 million. No additional costs would be incurred by state, local, and
tribal governments or the private sector as a result of this proposed
rule.
    There would be a reduction in benefits associated with extending
the compliance dates as described previously. Consumers eating non-
sprout covered produce would not enjoy the potential health benefits
(i.e., reduced risk of illness) provided by the provisions of subpart E
until 2 to 4 years (depending on the specific provision) later than
originally established in the produce safety regulation. Thus, the
annualized total benefits to consumers, discounted at 3 percent over 10
years, would decrease by $108 million from $1.033 billion to $925
million. Estimated changes in benefits and costs as a result of this
proposed extension are summarized in the following table.

   Table 4--Summary of the Changes in Benefits and Costs as a Result of This Proposed Rule, Annualized Over 10
                                       Years, in Millions of 2016 Dollars
----------------------------------------------------------------------------------------------------------------
                                                                                Benefits of
                                                                     Costs to       Benefits of    reduced risk
                                                     Costs to      industry with   reduced risk     of illness
                                                  industry under   the proposed     of illness       with the
                                                    2015 final      compliance      under 2015       proposed
                                                       rule          extension      final rule      compliance
                                                                                extension
----------------------------------------------------------------------------------------------------------------
Annualized 3%...................................            $404            $392          $1,033            $925
Annualized 7%...................................             382             370             983             874
Net Present Value 3%............................           3,443           3,340           8,811           7,886
Net Present Value 7%............................           2,681           2,598           6,901           6,143
----------------------------------------------------------------------------------------------------------------

    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities when ``the agency publishes a general notice of proposed
rulemaking.'' (5 U.S.C. 601(2)). We have analyzed this proposed rule
under the Regulatory Flexibility Act and determined that, because it
would only extend certain compliance dates for agricultural water
provisions in the produce safety regulation, it would not have a
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $148
million, using the most current (2016) Implicit Price Deflator for the
Gross Domestic Product. We have determined that this proposed rule
would not result in an expenditure in any year that meets or exceeds
this amount.
    Executive Order 13771, entitled Reducing Regulation and Controlling
Regulatory Costs, was issued on January 30, 2017. Section 2(a) of
Executive Order 13771 requires an agency, unless prohibited by law, to
identify at least two existing regulations to be repealed when the
agency publicly proposes for notice and comment or otherwise
promulgates a new regulation. In furtherance of this requirement,
section 2(c) of Executive Order 13771 requires that the new incremental
costs associated with new regulations shall, to the extent permitted by
law, be offset by the elimination of existing costs associated with at
least two prior regulations. This proposed rule is expected to be an
Executive Order 13771 deregulatory action. Details on the estimated
cost savings of this proposed rule can be found in the rule's economic
analysis.
    For interested persons, the detailed preliminary regulatory impact
analysis is available in the docket for this rule (Ref. 2) at https://www.regulations.gov, and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

IV. Analysis of Environmental Impact

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

V. Paperwork Reduction Act of 1995

    This proposed rule contains no collection of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 is not required.

VI. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we conclude that the proposed rule does not contain policies that have
federalism implications as defined in

the Executive order and, consequently, a federalism summary impact
statement is not required.

VII. Executive Order 13175

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have determined that
the proposed rule does not contain policies that have substantial
direct effects on one or more Indian tribes, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes. Accordingly, we conclude that the
proposed rule does not contain policies that have tribal implications
as defined in the Executive order and, consequently, a tribal summary
impact statement is not required.

VIII. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. FDA, ``Final Regulatory Impact Analysis, Standards for the
Growing, Harvesting, Packing and Holding of Produce for Human
Consumption.'' November 2015. Available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm472310.htm.
2. FDA, ``Preliminary Regulatory Impact Analysis, Preliminary
Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act
Analysis for the Standards for the Growing, Harvesting, Packing, and
Holding of Produce for Human Consumption; Extension of Compliance
Dates for Subpart E; Proposed Rule,'' 2017. Available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/.

    Dated: September 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-19434 Filed 9-12-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 72 (Monday, April 17, 2017)]
[Notices]
[Page 18141]
[FR Doc No: 2017-07711]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP17-645-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Algonquin Gas Transmission, LLC submits tariff filing
per 154.204: Negotiated Rates--Colonial Gas to BBPC 793648 & 793650 to
be effective 4/7/2017.
    Filed Date: 04/06/2017.
    Accession Number: 20170406-5296.
    Comment Date: 5:00 p.m. Eastern Time on Tuesday, April 18, 2017.

    Docket Numbers: RP17-646-000.
    Applicants: Gulfstream Natural Gas System, L.L.C.
    Description: Gulfstream Natural Gas System, L.L.C. submits tariff
filing per 154.204: Negotiated Rate--City of Lakeland--9198623 to be
effective 4/7/2017.
    Filed Date: 04/06/2017.
    Accession Number: 20170406-5324.
    Comment Date: 5:00 p.m. Eastern Time on Tuesday, April 18, 2017.

    Docket Numbers: RP17-647-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Request for Waiver and Extensions of El Paso Natural
Gas Company, L.L.C.
    Filed Date: 04/06/2017.
    Accession Number: 20170406-5540.
    Comment Date: 5:00 p.m. Eastern Time on Tuesday, April 18, 2017.

    Docket Numbers: RP17-648-000.
    Applicants: Dauphin Island Gathering Partners.
    Description: Dauphin Island Gathering Partners submits tariff
filing per 154.204: Negotiated Rate Filing 5-1-2017 to be effective 5/
1/2017.
    Filed Date: 04/07/2017.
    Accession Number: 20170407-5197.
    Comment Date: 5:00 p.m. Eastern Time on Wednesday, April 19, 2017.

    Docket Numbers: RP17-649-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Rockies Express Pipeline LLC submits tariff filing per
154.204: Neg Rate 2017-04-07 CP, BP to be effective 4/8/2017.
    Filed Date: 04/07/2017.
    Accession Number: 20170407-5208.
    Comment Date: 5:00 p.m. Eastern Time on Wednesday, April 19, 2017.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 10, 2017.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2017-07711 Filed 4-14-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 211 (Wednesday, November 2, 2022)]
[Notices]
[Pages 66192-66194]
[FR Doc No: 2022-23781]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0796]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Testing Communications by the Food and Drug
Administration's Center for Devices and Radiological Health

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on studies regarding
communications by FDA's Center for Devices and Radiological Health
(CDRH). This information will be used to explore concepts of interest
and assist in the development and modification of communication
messages and campaigns to fulfill the Agency's mission to protect the
public health.

DATES: Either electronic or written comments on the collection of
information must be submitted by January 3, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 3, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:

     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0796 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Testing Communications Regarding
Products Regulated by FDA's Center for Devices and Radiological
Health.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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, including
each proposed extension of an existing 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.

Testing Communications by FDA's Center for Devices and Radiological
Health

OMB Control Number 0910-0678--Extension

    FDA is authorized by section 1003(d)(2)(D) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)) to conduct educational
and public information programs. FDA must conduct needed research to
ensure that such programs have the highest likelihood of being
effective. Improving communications by FDA's CDRH involves many
research methods, including individual indepth interviews, mall-
intercept interviews, focus groups, self-administered surveys,
gatekeeper reviews, and omnibus telephone surveys.
    The information collected will serve three major purposes. First,
as formative research it will provide critical knowledge needed about
target audiences to develop messages and campaigns about product use.
Knowledge of consumer, caregiver, and healthcare professional decision-
making processes will provide a better understanding of target
audiences that FDA needs to design effective communication strategies,
messages, and labels.
    Second, as initial testing, the collected information will allow
FDA to assess the potential effectiveness of messages and materials in
reaching and successfully communicating with intended audiences.
Testing messages with a sample of the target audience will allow FDA to
refine messages while still in the developmental stage. Respondents
will be asked to give their reaction to the messages in either
individual or group settings.
    Third, as evaluative research, the collected information will allow
FDA to ascertain the effectiveness of the messages and the distribution
method in achieving the objectives of the message campaign. Evaluation
of message campaigns is a vital link in continuous improvement of
communications at FDA.
    FDA expects to conduct studies under this generic information
collection using a variety of research methods. We estimate that the
burden to respondents will average 16 minutes each (varying from 5
minutes to 90 minutes). FDA estimates the burden of this collection of
information based on prior experience with the various types of data
collection methods described earlier.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden 1 2
----------------------------------------------------------------------------------------------------------------
                                                   Number of
   Type of respondent/survey       Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
                                                 General Public
----------------------------------------------------------------------------------------------------------------
Individual indepth interviews.             420               1             420  0.75 (45                     315
                                                                                minutes).
General public focus group                 288               1             288  1.50 (1 hour, 30             432
 interviews.                                                                     minutes).
Intercept interviews: central              200               1             200  0.25 (15                      50
 location.                                                                       minutes).
Intercept interviews:                    4,000               1           4,000  0.08 (5 minutes)             320
 telephone.
Self-administered surveys.....           2,400               1           2,400  0.25 (15                     600
                                                                                minutes).
Gatekeeper reviews............             400               1             400  0.50 (30                     200
                                                                                minutes).
Omnibus surveys...............           1,200               1           1,200  0.17 (10                     204
                                                                                minutes).
                               ---------------------------------------------------------------------------------
    Total (general public)....  ..............  ..............  ..............  ................           2,121
----------------------------------------------------------------------------------------------------------------
                                             Healthcare Professional
----------------------------------------------------------------------------------------------------------------
Healthcare professional                     72               1              72  0.75 (45                      54
 individual indepth interviews.                                                  minutes).
Healthcare professional focus              144               1             144  1.50 (1 hour, 30             216
 group interviews.                                                               minutes).
                               ---------------------------------------------------------------------------------
    Total (healthcare           ..............  ..............  ..............  ................             270
     professional).
        Total (overall).......  ..............  ..............  ..............  ................           2,391
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Numbers have been rounded.

    Over the next 3-year approval period, we anticipate increasing our
capability to conduct more communication surveys, which aligns with
CDRH's strategic priorities. We have adjusted our burden estimates
accordingly. Additionally, we have added an estimated hour burden for
``healthcare professional individual indepth interviews.'' These
changes reflect an overall increase of 315 burden hours and a
corresponding increase of 276 responses annually.

    Dated: October 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23781 Filed 11-1-22; 8:45 am]
BILLING CODE 4164-01-P


From:
SINGLETON, KRIS E<EMAIL_ADDRESS>Sent:
Tuesday, October 5, 2021 1:10 PM
To:
Jones, DonnaLee<EMAIL_ADDRESS>BATTEN, KATIE M<EMAIL_ADDRESS>Cc:
GABRIELLE RAYMOND<EMAIL_ADDRESS>Subject:
RE: Do some HRSG operate while others are on bypass?

Hi!

Yes, they do. Let us know if you have other questions.

From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Tuesday, October 05, 2021 1:07 PM
To: BATTEN, KATIE M<EMAIL_ADDRESS>SINGLETON, KRIS E<EMAIL_ADDRESS>Cc: GABRIELLE RAYMOND<EMAIL_ADDRESS>Subject: Do some HRSG operate while others are on bypass?
Importance: High

Hi. This question just came up. I wanted to check with you.  Do some HRSG operate while others are on bypass?

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.


[Federal Register: June 1, 2006 (Volume 71, Number 105)]
[Notices]
[Page 31246-31249]
[DOCID:fr01jn06-123]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53857; File No. SR-ISE-2006-24]

Self-Regulatory Organizations; International Securities Exchange,
Inc.; Notice of Filing of a Proposed Rule Change and Amendment No. 1
Thereto To Permit the Listing and Trading of Quarterly Options Series

May 24, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 2, 2006, the International Securities Exchange, Inc. (``ISE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been substantially prepared by the
Exchange. The Exchange filed Amendment No. 1 to the proposed rule
change on May 17, 2006.\3\ The Commission is publishing this notice to
solicit comments on the proposed rule change, as amended, from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ In Amendment No. 1, a partial amendment, the Exchange made
minor modifications to the proposed rule text.
---------------------------------------------------------------------------

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

    The ISE proposes to amend its rules in order to list option series
that expire at the close of business on the last business day of a
calendar quarter. This rule change is being proposed on a pilot basis
for one year. The text of the proposed rule change, as amended, is set
forth below. Proposed new language is in italics; deletions are in
[brackets].
* * * * *

Rule 100. Definitions

    (a) The following terms, when used in these Rules, shall have the
meanings specified in this Chapter 1, unless the context indicates
otherwise. Any term defined in Article I of the Constitution and not
otherwise defined in this Chapter shall have the meaning assigned in
Article I of the Constitution.
    (1) through (34) No change.
    (35) The term ``Quarterly Options Series'' means a series in an
options class that is approved for listing and trading on the Exchange
in which the series is opened for trading on any business day and that
expires at the close of business on the last business day of a calendar
quarter.
    (35) through (44) Renumbered as (36) through (45).
* * * * *

Rule 504. Series of Options Contracts Open for Trading

    (a) After a particular class of options has been approved for
listing and trading on the Exchange, the Exchange from time to time may
open for trading series of options in that class. Only options
contracts in series of options currently open for trading may be
purchased or written on the Exchange. Prior to the opening of trading
in a given series, the Exchange will fix the expiration month, year and
exercise price of that series. For Short Term Option Series, the
Exchange will fix a specific expiration date and exercise price, as
provided in Supplementary Material .02. For Quarterly Options Series,
the Exchange will fix a specific expiration date and exercise price, as
provided in Supplementary Material .03.
    (b) through (h) No change.

Supplementary Material to Rule 504

    .01 No change.
    .02 No change.
    .03 Quarterly Options Series Pilot Program: For a one-year pilot
period, the Exchange may list and trade options series that expire at
the close of business on the last business day of a calendar quarter
(``Quarterly Options Series''). The Exchange may list Quarterly Options
Series for up to five (5) currently listed options classes that are
either index options or options on exchange traded funds. In addition,
the Exchange may also list Quarterly Options Series on any options
classes that are selected by other securities exchanges that employ a
similar pilot program under their respective rules. The one-year pilot
will commence the day the Exchange first initiates trading in a
Quarterly Options Series, which shall be no later than July 24, 2006.
    (a) The Exchange will list series that expire at the end of the
next consecutive four (4) calendar quarters, as well as the fourth
quarter of the next calendar year. For example, if the Exchange is
trading Quarterly Options Series in the month of May 2006, it will list
series that expire at the end of the second, third and fourth quarters
of 2006, as well as the

first and fourth quarters of 2007. Following the second quarter 2006
expiration, the Exchange will add series that expire at the end of the
second quarter of 2007.
    (b) The Exchange will not list a Short Term Option Series on an
options class whose expiration coincides with that of a Quarterly
Options Series on that same options class.
    (c) The strike price of each Quarterly Options Series will be fixed
at a price per share, with at least two strike prices above and two
strike prices below the value of the underlying security at about the
time that a Quarterly Options Series is opened for trading on the
Exchange. Additional Quarterly Options Series of the same class may be
opened for trading on the Exchange when the Exchange deems it necessary
to maintain an orderly market, to meet customer demand or when the
market price of the underlying security moves substantially from the
initial exercise price or prices. The opening of new Quarterly Options
Series shall not affect the series of options of the same class
previously opened.
    (d) The interval between strike prices on Quarterly Options Series
shall be the same as the interval for strike prices for series in that
same options class that expire in accordance with the normal monthly
expiration cycle.
* * * * *

Rule 2001. Definitions

    (a) through (k) No change.
    (l) The term ``Quarterly Options Series'' means, for the purposes
of Chapter 20, a series in an index options class that is approved for
listing and trading on the Exchange in which the series is opened for
trading on any business day and that expires at the close of business
on the last business day of a calendar quarter.
    (l) through (n) Renumbered as (m) through (o).
* * * * *

Rule 2004. Position Limits for Broad-Based Index Options

    (a) through (c) No change.
    (d) Positions in Short Term Option Series and Quarterly Options
Series shall be aggregated with positions in options contracts on the
same index.
* * * * *

Rule 2005. Position Limits for Industry Index Options

    (a) through (c) No change.
    (d) Positions in Short Term Option Series and Quarterly Options
Series shall be aggregated with positions in options contracts on the
same index.
* * * * *

Rule 2009. Terms of Index Options Contracts

    (a) through (e) No change.

Supplementary Material to Rule 2009

    .01 No change.
    .02 Quarterly Options Series Pilot Program: Notwithstanding the
restriction in Rule 2009(a)(3), for a one-year pilot period, the
Exchange may list and trade options series that expire at the close of
business on the last business day of a calendar quarter (``Quarterly
Options Series''). The Exchange may list Quarterly Options Series for
up to five (5) currently listed options classes that are either index
options or options on exchange traded funds. In addition, the Exchange
may also list Quarterly Options Series on any options classes that are
selected by other securities exchanges that employ a similar pilot
program under their respective rules. The one-year pilot will commence
the day the Exchange first initiates trading in a Quarterly Options
Series, which shall be no later than July 24, 2006.
    (a) The Exchange will list series that expire at the end of the
next consecutive four (4) calendar quarters, as well as the fourth
quarter of the next calendar year. For example, if the Exchange is
trading Quarterly Options Series in the month of May 2006, it will list
series that expire at the end of the second, third and fourth quarters
of 2006, as well as the first and fourth quarters of 2007. Following
the second quarter 2006 expiration, the Exchange will add series that
expire at the end of the second quarter of 2007.
    (b) The Exchange will not list a Short Term Option Series on an
options class whose expiration coincides with that of a Quarterly
Options Series on that same options class.
    (c) Quarterly Options Series shall be P.M. settled.
    (d) The strike price of each Quarterly Options Series will be fixed
at a price per share, with at least two strike prices above and two
strike prices below the value of the underlying security at about the
time that a Quarterly Options Series is opened for trading on the
Exchange. The Exchange may open for trading additional Quarterly
Options Series of the same class if the current index value of the
underlying index moves substantially from the exercise price of those
Quarterly Options Series that already have been opened for trading on
the Exchange. The exercise price of each Quarterly Options Series
opened for trading on the Exchange shall be reasonably related to the
current index value of the underlying index to which such series
relates at or about the time such series of options is first opened for
trading on the Exchange. The term ``reasonably related to the current
index value of the underlying index'' means that the exercise price is
within thirty percent (30%) of the current index value. The Exchange
may also open for trading additional Quarterly Options Series that are
more than thirty percent (30%) away from the current index value,
provided that demonstrated customer interest exists for such series, as
expressed by institutional, corporate, or individual customers or their
brokers. Market-makers trading for their own account shall not be
considered when determining customer interest under this provision.
    (e) The interval between strike prices on Quarterly Options Series
shall be the same as the interval for strike prices for series in that
same options class that expire in accordance with the normal monthly
expiration cycle.
* * * * *

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 these 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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend its rules to accommodate the listing
of option series that would expire at the close of business on the last
business day of a calendar quarter (``Quarterly Options Series'').
Specifically, Quarterly Options Series could be opened in any approved
option class \4\ on a business day (``Quarterly Options Opening Date'')
and would expire at the close of business on the last business day of a
calendar quarter (``Quarterly Options Expiration Date''). Specifically,
the Exchange would list series that expire at the end of the next four
consecutive calendar quarters, as well as the fourth

quarter of the next calendar year. For example, if the Exchange were
trading Quarterly Options Series in the month of May 2006, it would
list series that expire at the end of the second, third and fourth
quarters of 2006, as well as the first and fourth quarters of 2007.
Following the second quarter 2006 expiration, the Exchange would add
series that expire at the end of the second quarter of 2007.
---------------------------------------------------------------------------

    \4\ Quarterly Options Series may be opened in options on indexes
or options on Exchange Traded Fund (``ETFs'') that satisfy the
applicable listing criteria under ISE rules.
---------------------------------------------------------------------------

    Quarterly Options Series listed on currently approved option
classes would be P.M. settled and, in all other respects, would settle
in the same manner as do the monthly expiration series in the same
option class.
    The proposed rule change would allow the Exchange to open up to
five currently listed option classes that are either index options or
options on ETFs. The strike price for each series would be fixed at a
price per share, with at least two strike prices above and two strike
prices below the value of the underlying security at about the time
that a Quarterly Options Series is opened for trading on the Exchange.
The proposal would permit the Exchange to open for trading additional
Quarterly Options Series of the same class if the current index value
of the underlying index moves substantially from the exercise price of
those Quarterly Options Series already opened for trading on the
Exchange. The exercise price of each Quarterly Options Series opened
for trading on the Exchange would be required to be reasonably related
to the current index value of the underlying index to which such series
relates at or about the time such series of options were first opened
for trading on the Exchange. The term ``reasonably related to the
current index value of the underlying index'' means that the exercise
price is within thirty percent of the current index value. The Exchange
would also be permitted to open for trading additional Quarterly
Options Series that are more than thirty percent away from the current
index value, provided that demonstrated customer interest exists for
such series, as expressed by institutional, corporate, or individual
customers or their brokers. Market-makers trading for their own account
would not be considered when determining customer interest under this
provision.
    Because monthly option series expire on the third Friday of their
expiration month, a Quarterly Options Series, which would expire on the
last business day of the quarter, could never expire in the same week
in which a monthly option series in the same class expires. The same,
however, is not the case for Short Term Option Series. Quarterly
Options Series and Short Term Option Series on the same option class
could potentially expire concurrently under the proposal.\5\ Therefore,
to avoid any confusion in the marketplace, the proposal stipulates that
the Exchange may not list a Short Term Option Series that expires at
the end of the day on the same day as a Quarterly Options Series in the
same option class expires. In other words, the proposed rules would not
permit the Exchange to list a P.M.-settled Short Term Option Series on
an ETF or an index that would expire on a Friday that is the last
business day of a calendar quarter if a Quarterly Options Series on
that ETF or index were scheduled to expire on that day.
---------------------------------------------------------------------------

    \5\ The Exchange currently does not have any Short Term Option
Series listed for trading.
---------------------------------------------------------------------------

    However, the proposed rules would permit the Exchange to list an
A.M.-settled Short Term Option Series and a P.M.-settled Quarterly
Options Series in the same option class that both expire on the same
day (i.e., on a Friday that is the last business day of the calendar
quarter). The Exchange believes that the concurrent listing of an A.M.-
settled Short Term Option Series and a P.M.-settled Quarterly Options
Series on the same underlying ETF or index that expire on the same day
would not tend to cause the same confusion as would P.M.-settled short
term and quarterly series in the same option class, and would provide
investors with an additional hedging mechanism.
    Finally, the interval between strike prices on Quarterly Options
Series would be the same as the interval for strike price for series in
the same option class that expires in accordance with the normal
monthly expiration cycles.
    The Exchange believes that Quarterly Options Series would provide
investors with a flexible and valuable tool to manage risk exposure,
minimize capital outlays, and be more responsive to the timing of
events affecting the securities that underlie options contracts. At the
same time, the Exchange is cognizant of the need to be cautious in
introducing a product that can increase the number of outstanding
strike prices. For that reason, the Exchange proposes to employ a
limited pilot program (``Pilot Program'') for Quarterly Options Series.
Under the terms of the Pilot Program, the Exchange could select up to
five option classes on which Quarterly Options Series may be opened on
any Quarterly Options Opening Date. The Exchange would also be allowed
to list those Quarterly Options Series on any option class that is
selected by another securities exchange with a similar Pilot Program
under its rules. The Exchange believes that limiting the number of
option classes in which Quarterly Options Series may be opened would
help to ensure that the addition of the new series through this Pilot
Program would have only a negligible impact on the Exchange's and
Option Price Reporting Authority's (``OPRA'') quoting capacity. Also,
limiting the term of the Pilot Program for a period of one year will
allow the Exchange and the Commission to determine whether the Pilot
Program should be extended, expanded, and/or made permanent.
    If the Exchange were to propose an extension or an expansion of the
Pilot Program, or were the Exchange to propose to make the Pilot
Program permanent, the Exchange would submit, along with any filing
proposing such amendments to the Pilot Program, a Pilot Program Report
(``Report'') that will provide an analysis of the Pilot Program
covering the entire period during which the Pilot Program was in
effect. The Report would include, at a minimum: (1) Data and written
analysis on the open interest and trading volume in the classes for
which Quarterly Options Series were opened; (2) an assessment of the
appropriateness of the option classes selected for the Pilot Program;
(3) an assessment of the impact of the Pilot Program on the capacity on
ISE, OPRA and on market data vendors (to the extent data from market
data vendors is available); (4) any capacity problems or other problems
that arose during the operation of the Pilot Program and how ISE
addressed such problems; (5) any complaints that ISE received during
the operation of the Pilot Program and how ISE addressed them; and (6)
any additional information that would assist the Commission in
assessing the operation of the Pilot Program. The Exchange must submit
the Report to the Commission at least sixty days prior to the
expiration date of the Pilot Program.
    Alternately, at the end of the Pilot Program, if the Exchange
determines not to propose an extension or an expansion of the Pilot
Program, or if the Commission determines not to extend or expand the
Pilot Program, the Exchange would no longer list any additional
Quarterly Options Series and would limit all existing open interest in
Quarterly Options Series to closing transactions only.
    Finally, the Exchange represents that it has the necessary systems
capacity to support the new option series that would result from the
introduction of Quarterly Options Series. The Exchange has provided to
the Commission information in a confidential

submission that supports its system capacity representations.
2. Statutory Basis
    The Exchange believes that the introduction of Quarterly Options
Series will attract order flow to the Exchange, increase the variety of
listing options available to investors, and provide investors with a
valuable hedging tool. Accordingly, the Exchange believes the proposed
rule change is consistent with Section 6(b) of the Act \6\ in general,
and furthers the objectives of Section 6(b)(5) of the Act \7\ in
particular, in that it is designed to promote just and equitable
principles of trade and, in general, to protect investors and the
public interest.
---------------------------------------------------------------------------

    \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

    The Exchange does not believe that the proposed rule change would
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 has not solicited comments on this proposed rule
change. The Exchange has not received any unsolicited written comments
from members or other interested parties.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) by order approve such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, 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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-ISE-2006-24 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.
    All submissions should refer to File Number SR-ISE-2006-24. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-ISE-2006-24 and should be submitted on or before June
22, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Lynn Taylor,
Assistant Secretary.
[FR Doc. E6-8435 Filed 5-31-06; 8:45 am]

BILLING CODE 8010-01-P


From: Farmer, Mark [ mailto: Mark. Farmer@ am. sony. com] Sent: Thursday, March 20, 2003 10: 13 AM To: ' Reeves, David' Subject: RE: Enclosure in Word Dave,

Sorry for the delay; have been out of the office.

1) We actually use metallic cobalt in one of our processes. We are producing Advanced Metal Evaporated ( AME) tape for high data storage. The process involves the vaporization of cobalt under a vacuum and depositing it onto a plastic film. There are very few emissions from the process; we do have baghouses that collect cobalt dust from the cleaning of parts and equipment. 2) We also use some cobalt doped iron oxide powder (~ 3 wt%) in our conventional coating process; there are some fugitives from this.

Both processes do not result in emissions outside the buildings where the process resides; in reality, any dust generated settles very quickly and more of a housekeeping issue then anything else.

Hope this answers your questions.

Thanks,

Mark


Table 1. Total Annual Federal Government Burden Calculation for three years of ICR Activity Person hours Total Number of Total Annual Annual Per response or Responses or Tasks Person Hours Labor Costs Task , A Per year, B ( Hr/ year) ($/ Yr) ( a) 1. Review Reports ( AxB) a. initial notification 2 1 2 69.38 b. compliance status notification 4 1 4 138.76 c. performance test notification 1 1 1 34.69 d. performance test report 8 1 8 277.52 e. startup/ shutdown/ malfunction report 2 260 40 1387.60 f. excess emissions and CMS performance report 4 65 260 9019.40 Average Annual Federal Gov. Burden 395 10,927.35 ( A) cost is based on average wage of GS 10 step 1 employee rate ($ 16.52 hr + 110% overhead) = $ 34.69