[Federal Register: March 27, 2008 (Volume 73, Number 60)]
[Notices]
[Page 16311-16312]
[DOCID:fr27mr08-61]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0180]

Draft Guidance for Industry on Coronary Drug Eluting Stents-
Nonclinical and Clinical Studies; 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availability of a draft guidance for industry entitled ``Coronary Drug
Eluting Stents--Nonclinical and Clinical Studies.'' This draft guidance
is intended to provide recommendations to sponsors or applicants
planning to develop, or to submit to FDA, a marketing application for a
coronary drug eluting stent (DES). The draft guidance discusses the
clinical studies that should be performed and the data that should be
submitted to support such an application. The draft guidance is being
issued in two parts. The companion document provides additional and
more detailed guidance on some of the recommendations included in this
document. The companion document is intended to be used together with
this draft guidance.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by July 25, 2008.

ADDRESSES:  Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to

http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Ashley Boam, Center for Devices and Radiological Health (HFZ-450),
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850,<PHONE_NUMBER>, or
    Devi Kozeli, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4183, Silver
Spring, MD 20903-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Coronary Drug Eluting Stents--Nonclinical and Clinical
Studies.'' Coronary stents are implantable devices that are placed
percutaneously in one or more coronary arteries to maintain patency. As
defined by section 503(g) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353(g)), DESs are considered combination products because
they are a combination of two different types of regulated components
(a device and a drug) that are physically and/or chemically combined
and produced as a single entity (21 CFR 3.2(e)(1)). A combination
product is assigned to an agency component, such as the Center for
Devices and Radiological Health (CDRH) or the Center for Drug
Evaluation and Research (CDER) for premarket review and regulation
based on a determination of the product's primary mode of action. In
response to several requests for designation under 21 CFR 3.7, the
agency determined that the primary mode of action for current DESs is
that of the device component in maintaining coronary artery patency;
the drug component plays a secondary role in preventing restenosis,
augmenting the safety and/or effectiveness of the uncoated (bare)
stent.\1\ Therefore, the premarket review and regulatory responsibility
has been assigned to CDRH. Nevertheless, careful consideration should
be given to characterizing the drug component of DESs. This draft
guidance is intended to provide recommendations on meeting the
regulatory requirements for both the drug and device components of a
DES.
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    \1\ See ``Jurisdictional Update: Drug-Eluting Cardiovascular
Stents,'' http://www.fda.gov/oc/combination/stents.html. This
Jurisdictional Update is applicable to DESs for which the primary
mode of action is the device component in maintaining vessel
patency. However, a DES for which the primary mode of action is
attributable to the drug component would be assigned to CDER.
---------------------------------------------------------------------------

    DESs incorporate a pharmacologically active agent (drug) that is
delivered at the site of stent deployment to reduce the incidence of
restenosis due to neointimal hyperplasia associated with bare metal
stenting. In many cases, the drug is incorporated into and released
from a polymeric coating of sufficient capacity to accommodate the
selected dose and to modulate its delivery at the intended site of
action and for the intended duration. The chemical, physical, and
mechanical attributes of the polymer coating system are important for
stent deployment, biocompatibility, and stability. To perform a
regulatory assessment of a DES, FDA must review data from a
comprehensive evaluation of individual components (drug, polymer, and
stent), as well as from a comprehensive evaluation of the finished
drug-device combination product.
    This draft guidance clarifies a number of issues related to the
development DESs including the following.
     How to characterize the drug substance, including
chemistry, nonclinical systemic and local tissue pharmacology and
toxicology, and how to evaluate potential for and consequences of
systemic clinical exposure.
     How to characterize the drug-device combination product,
including the chemical/physical/mechanical properties of the DES, the
nonclinical local vascular and regional myocardial toxicology, and the
clinical performance of the drug-stent combination.
     Regulatory considerations that are unique to DES
combination products.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

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

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 211 (current good
manufacturing practice for finished pharmaceuticals) have been approved
under OMB control number 0910-0139. The collections of information in
21 CFR parts 312 (investigational new drug application) and 314
(applications for FDA approval to market a new drug) have been approved
under OMB control numbers 0910-0014 and 0910-0001. The collections of
information in FDA's medical devices regulations in 21 CFR parts 801
(labeling), 803 (medical device reporting), 812 (investigational device
exemptions), 814 (premarket approval of medical devices), and 820
(quality system regulation) have been approved under OMB control
numbers 0910-0485, 0910-0437, 0910-0078, 0910-0231, and 0910-0073.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://
www.fda.gov/ohrms/dockets/default.htm.

    Dated: March 21, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-6210 Filed 3-26-08; 8:45 am]

BILLING CODE 4160-01-S


Comment Info: =================

General Comment:Dear Mr. Zeller,

I am writing this letter to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491.

180 days would be a more realistic time to gather the information needed in order to craft sensible guidelines for this important product.

Electronic cigarettes saved my life. I am a Physician Assistant specializing in Interventional Cardiology who smoked for 30 years. The shame in that alone was a weight on my practice, I felt like nothing but a hypocrite yet I was unable to free myself from smoking for a large portion of my life. The first time I puffed on an electronic cigarette was the last moment I felt like smoking a real cigarette. It has now been 7 months and my health has improved dramatically.

This product frees people from a life of smoking, which causes untold death and formidable expense. It is not a product that deserves banishment but study. We who use this product want a safe product, we understand that some standards for all products in this category are fine. What we do not want is for this product to undergo the stigma that is rightly attached to cigarettes.

We need the FDA to be sensible here, to be a voice of reason so that local and state governments do not force us to stand with smokers outside in the cold. We need the FDA to note that the health benefits far outweigh any potential risk they may or may not incur. In short, we need the FDA to treat this product like a nicotine replacement product, and taxed accordingly. Which is to say, at no punitive level.

I find it odd that some argument is made that this product doesn't stop all smoking from happening once a user tries it. NRT has been on the shelves for years and its efficacy has always been rather weak. Why are we holding E-Cigs to a higher standard?

Do we need to know more? Yes. Lets fund a study and get to the bottom of it. Lets make standards that companies have to meet, I have no problem with that. But lets not make the requirements so onerous that it forces everyone making these devices and liquids go out of business. Every ingredient currently used meets existing standards individually, if by coupling the ingredients no risk is ascertained then a simple statement of that fact is what we need to see.

I would be delighted to provide any additional information or testimonials you may need. I understand there are folks on both sides of the issue that are more militant than I am. I am simply a consumer of a product that saved my life, and I am concerned that knee jerk responses of the militant anti-smoking crowd will flock to this device and attempt to destroy it. For what reason I have no idea.

Thanks for your time,

James Torey PA-C Physician Assistant Certified Detroit, Michigan


[Federal Register Volume 86, Number 70 (Wednesday, April 14, 2021)]
[Notices]
[Pages 19623-19625]
[FR Doc No: 2021-07641]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0878]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket
Notification for a New Dietary Ingredient

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by May 14, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0330. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Premarket Notification for a New Dietary Ingredient

OMB Control Number 0910-0330--Extension

    This information collection supports Agency regulations. Under
section 413(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 350b(a)), the manufacturer or distributor of a new dietary
ingredient (NDI), or of the dietary supplement that contains the NDI,
must submit a premarket notification to FDA (as delegate for the
Secretary of Health and Human Services) at least 75 days before
introducing the product into interstate commerce or delivering it for
introduction into interstate commerce, unless the NDI and any other
dietary ingredients in the dietary supplement ``have been present in
the food supply as an article used for food in a form in which the food
has not been chemically altered'' (21 U.S.C. 350b(a)(1)). The
notification must contain the information which provides the basis on
which the manufacturer or distributor of the NDI or dietary supplement
has concluded that the dietary supplement containing the NDI will
reasonably be expected to be safe (21 U.S.C. 350b(a)(2)).
    FDA's implementing regulation, Sec.  190.6 (21 CFR 190.6),
specifies the procedure for submitting a premarket NDI notification and
the information the manufacturer or distributor must include in the
notification. Under Sec.  190.6(b), the notification must include the
following: (1) The name and complete address of the manufacturer or
distributor; (2) the name of the NDI; (3) a description of the dietary
supplement(s) that contains the NDI, including the level of the NDI in
the dietary supplement and the conditions of use recommended or
suggested in the labeling of the dietary supplement, or if no
conditions of use are recommended or suggested in the supplement's
labeling, the ordinary conditions of use of the supplement; (4) the
history of use or other evidence of safety establishing that the NDI
will reasonably be expected to be safe when used under the conditions
recommended or suggested in the labeling of the dietary supplement; and
(5) the signature of a responsible person designated by the
manufacturer or distributor.
    These premarket notification requirements are designed to enable us
to monitor the introduction into the marketplace of NDIs and dietary
supplements that contain NDIs in order to protect consumers from
ingredients and products whose safety is unknown. We use the
information collected in NDI notifications to evaluate the safety of
NDIs in dietary supplements and to support regulatory action against
ingredients and products that are potentially unsafe.
    FDA developed an electronic portal (Form FDA 3880) that respondents
may use to electronically submit their notifications to us via the
Center for Food Safety and Applied Nutrition (CFSAN) Online Submission
Module (COSM). COSM was developed to assist respondents when filing
regulatory submissions and is specifically designed to aid users
wishing to file submissions with CFSAN. COSM allows safety and other
information to be uploaded and submitted online via Form FDA 3880. This
form provides a standard format to describe the history of use or other
evidence of safety on which the manufacturer or distributor bases its
conclusion that the NDI is reasonably expected to be safe under the
conditions of use recommended or suggested in the labeling of the
dietary supplement, as well as a description of the ingredient and
other information. Firms that prefer to submit a paper notification in
a format of their own choosing have the option to do so; however, Form
FDA 3880 prompts a submitter to input the elements of an NDI
notification in a standard format that we will be able to review
efficiently. Form FDA 3880 may be accessed at https://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/default.htm.
    Description of Respondents: The respondents to this collection of
information are certain manufacturers and distributors in the dietary
supplement industry.
    In the Federal Register of October 16, 2020 (85 FR 65830), we
published a 60-day notice requesting public comment on the proposed
collection of information. A number of comments were received
expressing general interest in labeling requirements applicable to
dietary supplements. Other comments were received pertaining to related
Agency draft guidance, one suggesting that FDA: (1) Failed to account
for the cost of removing from the market dietary supplements suddenly
deemed New Dietary Ingredients for the first time in the guidance; (2)
substantially underestimated the number and cost of New Dietary
Ingredient submissions that must be filed to comply with the guidance;
and (3) grossly and dangerously undervalued the economic impact the
guidance will have on the dietary supplement industry and the economy
as a whole.
    While we appreciate all feedback regarding Agency information
collection activities, as we communicated in our notice of March 28,
2018 (83 FR 13281), the data analysis offered by the comment does not
provide a basis upon which we can revise our burden estimate under the
PRA. Regulatory requirements regarding premarket notification for new
dietary ingredients are set forth under 21 CFR 190.6 and were
established by final rule of September 23, 1997 (62 FR 49886). Notices
published in the Federal Register in compliance with the PRA seek to
improve information collection activities by evaluating our need for
the information discussed in the notice and specific ways we might
utilize technology and/or enhance our collection techniques and
mechanisms to minimize burden on respondents who are subject to
applicable those requirements. Finally, notices of availability for
Agency guidance documents are published consistent with regulations in
21 CFR 10.115 (Good Guidance Practices), which provide for public
comment at any time.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           21 CFR section                               Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
190.6; Dietary Supplements.........................................              55                1               55               20            1,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

    Based on our experience with the information collection over the
past 3 years, we estimate that 55 respondents will submit 1 premarket
notification each. We estimate that extracting and summarizing the
relevant information from what exists in the company's files and
presenting it in a format that meets the requirements of Sec.  190.6
will take approximately 20 hours of work per notification. We believe
that the burden of the premarket notification requirement on industry
is reasonable because we are requesting only safety and identity
information that the manufacturer or distributor should already have
developed to satisfy itself that a dietary supplement containing the
NDI is in compliance with the FD&C Act.
    If the required premarket notification is not submitted to FDA,
section 413(a) of the FD&C Act provides that the dietary supplement
containing the NDI is deemed to be adulterated under section 402(f) of
the FD&C Act (21 U.S.C. 342(f)). Even if the notification is submitted
as required, the dietary supplement containing the NDI is adulterated
under section 402(f) of the FD&C Act unless there is a history of use
or other evidence of safety establishing that the NDI, when used under
the conditions recommended or suggested in the labeling of the dietary
supplement, will reasonably be expected to be safe. This requirement is
separate from and additional to the requirement to submit a premarket
notification for the NDI. FDA's regulation on NDI notifications, Sec.
190.6(a), requires the manufacturer or distributor of the dietary
supplement or of the NDI to submit to FDA the information that forms
the basis for its conclusion that a dietary supplement containing the
NDI will reasonably be expected to be safe. Thus, Sec.  190.6 only
requires the manufacturer or distributor to extract and summarize
information that should have already been developed to meet the safety
requirement in section 413(a)(2) of the FD&C Act.
    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: April 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07641 Filed 4-13-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: June 28, 2007 (Volume 72, Number 124)]
[Proposed Rules]
[Page 35376-35377]
[DOCID:fr28jn07-16]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1983-0002; FRL-8331-3]

National Oil and Hazardous Substance Pollution Contingency Plan;
National Priorities List

AGENCY: Environmental Protection Agency.

ACTION: Notice of intent to delete the Mannheim Avenue Dump Superfund
Site from the National Priorities List.

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SUMMARY: The Environmental Protection Agency (EPA) Region II is issuing
a notice of intent to delete the Mannheim Avenue Dump Superfund Site
(Site) located in Galloway Township, New Jersey from the National
Priorities List (NPL) and requests public comments on this notice of
intent. The NPL, promulgated pursuant to section 105 of the
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA) of 1980, as amended, is found at Appendix B of 40 CFR part
300, which is the National Oil and Hazardous Substances Pollution
Contingency Plan (NCP). The EPA and the State of New Jersey, through
the New Jersey Department of Environmental Protection, have determined
that all appropriate response actions under CERCLA, including operation
and maintenance and five-year reviews, have been completed. However,
this deletion does not preclude future actions under Superfund.
    In the ``Rules and Regulations'' Section of today's Federal
Register, we are publishing a direct final notice of deletion of the
Mannheim Avenue Dump Superfund Site without prior notice of intent to
delete because we view this as a noncontroversial revision and
anticipate no adverse comment. We have explained our reasons for this
deletion in the preamble to the direct final deletion. If we receive no
adverse comment(s) on this notice of intent to delete or the direct
final notice of deletion, we will not take further action on this
notice of intent to delete. If we receive adverse comment(s), we will
withdraw the direct final notice of deletion and it will not take
effect. We will, as appropriate, address all public comments in a
subsequent final deletion notice based on this notice of intent to
delete. We will not institute a second comment period on this notice of
intent to delete. Any parties interested in commenting must do so at
this time. For additional information, see the direct final notice of
deletion which is located in the Rules section of this Federal
Register.

DATES: Comments concerning this Site must be received by July 30, 2007.

ADDRESSES: Submit your comments, identified by Docket ID no. EPA-HQ-
SFUND-1983-0002, by one of the following methods:
     http://www.regulations.gov. Follow on-line instructions

for submitting comments.
     E-mail<EMAIL_ADDRESS>Nigel Robinson, Remedial
Project Manager<EMAIL_ADDRESS>Pat Seppi, Community Involvement
Coordinator.
     Fax:<PHONE_NUMBER>.
     Mail: Nigel Robinson, Remedial Project Manager, U.S.
Environmental Protection Agency, Region II, Emergency & Remedial
Response Division, 290 Broadway, 19th Floor, New York, NY 10007 or Pat
Seppi, Community Involvement Coordinator, U.S. Environmental Protection
Agency, Region II, Public Affairs Division, 290 Broadway, 26th Floor,
New York, NY 10007.
    Hand delivery: Nigel Robinson, Remedial Project Manager, U.S.
Environmental Protection Agency, Emergency & Remedial Response
Division, 290 Broadway, 19th Floor, New York, NY 10007.
    Such deliveries are only accepted during the Docket's normal hours
of operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID no. EPA-HQ-SFUND-
1983-0002. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site is an ``anonymous

access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through http://www.regulations.gov
, your e-mail address will be automatically captured

and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.
    Docket: All documents in the docket are listed in the http://www.regulations.gov
 index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statue. Certain other material, such
as copyrighted material, will be publicly available only in the hard
copy. Publicly available docket materials are available either
electronically in http://www.regulations.gov or in hard copy at:

U.S. Environmental Protection Agency, Region II, Superfund Records
Center, 290 Broadway, Room 1828, New York, New York 10007-1866, (212)
637-4308; Hours: 9 a.m. to 5 p.m., Monday through Friday; and at
Atlantic County Library, Galloway Township Branch, 306 W. Jimmie Leeds
Road, Pomona, NJ 08240; Hours: Mon.-Th., 9 a.m.-8 p.m., Fri.-Sat., 9
a.m.-5 p.m.,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Nigel Robinson, Remedial Project
Manager, U.S. Environmental Protection Agency, Region II, 290 Broadway,
19th Floor, New York, NY 10007,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous waste, Hazardous substances, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O.
12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR
2923, 3 CFR, 1987 Comp., p. 193.

    Dated: April 27, 2007.
Alan J. Steinberg,
Regional Administrator, Region 2.
[FR Doc. E7-12537 Filed 6-27-07; 8:45 am]

BILLING CODE 6560-50-P


From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Tuesday, July 26, 2022 4:16 PM
To:
<EMAIL_ADDRESS>Cc:
STUCKEY, MATT<EMAIL_ADDRESS>Mooney, John<EMAIL_ADDRESS>French, Chuck<EMAIL_ADDRESS>Jones, DonnaLee<EMAIL_ADDRESS>Coke ICR2<EMAIL_ADDRESS>Subject:
UPDATE to CAA section 114 request for Coke Ovens RTR - email for SunCoke

Hello Ms. Batten,

This email contains a correction and update to my email of 6/29/22 in regard to the Clean Air Act Section (CAA) section 114 information and test request letter that was signed on June 28, 2022, that requested information from SunCoke's East Chicago, IN, Vansant, VA, and Franklin Furnace, OH, coke oven battery facilities.

This enclosed letter is a correction to the previous letter that eliminates any requirements for SunCoke's East Chicago, IN, facility. I have attached a revised answer file for Enclosure 1 that only contains information for Suncoke's facilities in Vansant, VA, and Franklin Furnace, OH.

Please let me know if you have any questions about this email. Thank you in advance for your efforts on this CAA section 114 request.

Sincerely,

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.

<< REV_114_Letter_CokeOvens_SunCoke.pdf >>
<< ANSWER-Coke-Enc1-Questionnaire ICR-20162022-Suncoke-07-25-22.xlsx >>


[Federal Register: September 18, 2006 (Volume 71, Number 180)]
[Rules and Regulations]
[Page 54580-54582]
[DOCID:fr18se06-7]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 211

[Release No. SAB 108]

Staff Accounting Bulletin No. 108

AGENCY: Securities and Exchange Commission.

ACTION: Publication of Staff Accounting Bulletin.

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

SUMMARY: The interpretations in this Staff Accounting Bulletin express
the staff's views regarding the process of quantifying financial
statement misstatements. The staff is aware of diversity in practice.
For example, certain registrants do not consider the effects of prior
year errors on current year financial statements, thereby allowing
improper assets or liabilities to remain unadjusted. While these errors
may not be material if considered only in relation to the balance
sheet, correcting the errors could be material to the current year
income statement. Certain registrants have proposed to the staff that
allowing these errors to remain on the balance sheet as assets or
liabilities in perpetuity is an appropriate application of generally
accepted accounting principles. The staff believes that approach is not
in the best interest of the users of financial statements. The
interpretations in this Staff Accounting Bulletin are being issued to
address diversity in practice in quantifying financial statement
misstatements and the potential under current practice for the build up
of improper amounts on the balance sheet.

DATES: September 13, 2006.

FOR FURTHER INFORMATION CONTACT: Mark S. Mahar, Office of the Chief
Accountant<PHONE_NUMBER>, Todd E. Hardiman, Division of Corporation
Finance<PHONE_NUMBER>, or Toai P. Cheng<PHONE_NUMBER>, Division of
Investment Management, Securities and Exchange Commission, 100 F
Street, NE., Washington, DC 20549.

SUPPLEMENTARY INFORMATION: The statements in staff accounting bulletins
are not rules or interpretations of the Commission, nor are they
published as bearing the Commission's official approval. They represent
interpretations and practices followed by the Division of Corporation
Finance, the Division of Investment Management and the Office of the
Chief Accountant in administering the disclosure requirements of the
Federal securities laws.

    Dated: September 13, 2006.
Nancy M. Morris,
Secretary.

PART 211--[AMENDED]

0
Accordingly, Part 211 of Title 17 of the Code of Federal Regulations is
amended by adding Staff Accounting Bulletin No. 108 to the table found
in Subpart B.

Staff Accounting Bulletin No. 108

    The staff hereby adds Section N to Topic 1, Financial Statements,
of the Staff Accounting Bulletin Series. Section N provides guidance on
the consideration of the effects of prior year misstatements in
quantifying current year misstatements for the purpose of a materiality
assessment.

    Note: The text of SAB 108 will not appear in the Code of Federal
Regulations.

Topic 1: Financial Statements

* * * * *

N. Considering the Effects of Prior Year Misstatements When Quantifying
Misstatements in Current Year Financial Statements

    Facts: During the course of preparing annual financial statements,
a registrant is evaluating the materiality of an improper expense
accrual (e.g., overstated liability) in the amount of $100, which has
built up over 5 years, at $20 per year.\1\ The registrant previously
evaluated the misstatement as being immaterial to each of the prior
year financial statements (i.e., years 1-4). For the purpose of
evaluating materiality in the current year (i.e., year 5), the
registrant quantifies the error as a $20 overstatement of expenses.
---------------------------------------------------------------------------

    \1\ For purposes of these facts, assume the registrant properly
determined that the overstatement of the liability resulted from an
error rather than a change in accounting estimate. See FASB
Statement 154, Accounting Changes and Error Corrections, paragraph
2, for the distinction between an error and a change in accounting
estimate.
---------------------------------------------------------------------------

    Question 1: Has the registrant appropriately quantified the amount
of this error for the purpose of evaluating materiality for the current
year?
    Interpretive Response: No. In this example, the registrant has only
quantified the effects of the identified unadjusted error that arose in
the current year income statement. The staff believes a registrant's
materiality evaluation of an identified unadjusted error should
quantify the effects of the identified unadjusted error on each
financial statement and related financial statement disclosure.
    Topic 1M notes that a materiality evaluation must be based on all
relevant quantitative and qualitative factors.\2\ This analysis
generally begins with quantifying potential misstatements to be
evaluated. There has been diversity in practice with respect to this
initial step of a materiality analysis.
---------------------------------------------------------------------------

    \2\ Topic 1N addresses certain of these quantitative issues, but
does not alter the analysis required by Topic 1M.
---------------------------------------------------------------------------

    The diversity in approaches for quantifying the amount of
misstatements primarily stems from the effects of misstatements that
were not corrected at the end of the prior year (``prior year
misstatements''). These prior year misstatements should be considered
in quantifying misstatements in current year financial statements.
    The techniques most commonly used in practice to accumulate and
quantify misstatements are generally referred to as the ``rollover''
and ``iron curtain'' approaches.
    The rollover approach, which is the approach used by the registrant
in this example, quantifies a misstatement based on the amount of the
error originating in the current year income statement. Thus, this
approach ignores the effects of correcting the portion of the current
year balance sheet misstatement that originated in prior years (i.e.,
it ignores the ``carryover effects'' of prior year misstatements).
    The iron curtain approach quantifies a misstatement based on the
effects of correcting the misstatement existing in the balance sheet at
the end of the current year, irrespective of the misstatement's year(s)
of origination. Had the registrant in this fact pattern applied the
iron curtain approach, the misstatement would have been quantified as a
$100 misstatement based on the end of year balance sheet misstatement.
Thus, the adjustment needed to correct the financial statements for the
end of year error would be to reduce the liability by $100 with a
corresponding decrease in current year expense.
    As demonstrated in this example, the primary weakness of the
rollover approach is that it can result in the accumulation of
significant misstatements on the balance sheet that are deemed
immaterial in part because the amount that originates in each year is
quantitatively small. The staff is aware of situations in which a
registrant, relying on the rollover approach, has allowed an erroneous
item to accumulate on the balance sheet to the point where eliminating
the improper asset or liability would itself result in a material error
in the income statement if adjusted in the current year. Such
registrants have sometimes concluded that the improper asset or
liability should remain on the balance sheet into perpetuity.
    In contrast, the primary weakness of the iron curtain approach is
that it does not consider the correction of prior year misstatements in
the current year (i.e., the reversal of the carryover effects) to be
errors. Therefore, in this example, if the misstatement was corrected
during the current year such that no error existed in the balance sheet
at the end of the current year, the reversal of the $80 prior year
misstatement would not be considered an error in the current year
financial statements under the iron curtain approach. Implicitly, the
iron curtain approach assumes that because the prior year financial
statements were not materially misstated, correcting any immaterial
errors that existed in those statements in the current year is the
``correct'' accounting, and is therefore not considered an error in the
current year. Thus, utilization of the iron curtain approach can result
in a misstatement in the current year income statement not being
evaluated as an error at all.
    The staff does not believe the exclusive reliance on either the
rollover or iron curtain approach appropriately quantifies all
misstatements that could be material to users of financial statements.
    In describing the concept of materiality, FASB Concepts Statement
No. 2, Qualitative Characteristics of Accounting Information, indicates
that materiality determinations are based on whether ``it is probable
that the judgment of a reasonable person relying upon the report would
have been changed or influenced by the inclusion or correction of the
item'' (emphasis added).\3\ The staff believes registrants must
quantify the impact of correcting all misstatements, including both the
carryover and reversing effects of prior year misstatements, on the
current year financial statements. The staff believes that this can be
accomplished by quantifying an error under both the rollover and iron
curtain approaches as described above and by evaluating the error
measured under each approach. Thus, a registrant's financial statements
would require adjustment when either approach results in quantifying a
misstatement that is material, after considering all relevant
quantitative and qualitative factors.
---------------------------------------------------------------------------

    \3\ Concepts Statement 2, paragraph 132. See also Concepts
Statement 2, Glossary of Terms--Materiality.
---------------------------------------------------------------------------

    As a reminder, a change from an accounting principle that is not
generally accepted to one that is generally accepted is a correction of
an error.\4\
---------------------------------------------------------------------------

    \4\ Statement 154, paragraph 2h.
---------------------------------------------------------------------------

    The staff believes that the registrant should quantify the current
year misstatement in this example using both the iron curtain approach
(i.e., $100) and the rollover approach (i.e., $20). Therefore, if the
$100 misstatement is considered material to the financial statements,
after all of the relevant quantitative and qualitative factors are

considered, the registrant's financial statements would need to be
adjusted.
    It is possible that correcting an error in the current year could
materially misstate the current year's income statement. For example,
correcting the $100 misstatement in the current year will:
     Correct the $20 error originating in the current year;
     Correct the $80 balance sheet carryover error that
originated in Years 1 through 4; but also
     Misstate the current year income statement by $80.
    If the $80 understatement of current year expense is material to
the current year, after all of the relevant quantitative and
qualitative factors are considered, the prior year financial statements
should be corrected, even though such revision previously was and
continues to be immaterial to the prior year financial statements.
Correcting prior year financial statements for immaterial errors would
not require previously filed reports to be amended. Such correction may
be made the next time the registrant files the prior year financial
statements.
    The following example further illustrates the staff's views on
quantifying misstatements, including the consideration of the effects
of prior year misstatements:
    Facts: During the course of preparing annual financial statements,
a registrant is evaluating the materiality of a sales cut-off error in
which $50 of revenue from the following year was recorded in the
current year, thereby overstating accounts receivable by $50 at the end
of the current year. In addition, a similar sales cut-off error existed
at the end of the prior year in which $110 of revenue from the current
year was recorded in the prior year. As a result of the combination of
the current year and prior year cut-off errors, revenues in the current
year are understated by $60 ($110 understatement of revenues at the
beginning of the current year partially offset by a $50 overstatement
of revenues at the end of the current year). The prior year error was
evaluated in the prior year as being immaterial to those financial
statements.
    Question 2: How should the registrant quantify the misstatement in
the current year financial statements?
    Interpretive Response: The staff believes the registrant should
quantify the current year misstatement in this example using both the
iron curtain approach (i.e., $50) and the rollover approach (i.e.,
$60). Therefore, assuming a $60 misstatement is considered material to
the financial statements, after all relevant quantitative and
qualitative factors are considered, the registrant's financial
statements would need to be adjusted.
    Further, in this example, recording an adjustment in the current
year could alter the amount of the error affecting the current year
financial statements. For instance:
     If only the $60 understatement of revenues were to be
corrected in the current year, then the overstatement of current year
end accounts receivable would increase to $110; or,
     If only the $50 overstatement of accounts receivable were
to be corrected in the current year, then the understatement of current
year revenues would increase to $110.
    If the misstatement that exists after recording the adjustment in
the current year financial statements is material (considering all
relevant quantitative and qualitative factors), the prior year
financial statements should be corrected, even though such revision
previously was and continues to be immaterial to the prior year
financial statements. Correcting prior year financial statements for
immaterial errors would not require previously filed reports to be
amended. Such correction may be made the next time the registrant files
the prior year financial statements.
    If the cut-off error that existed in the prior year was not
discovered until the current year, a separate analysis of the financial
statements of the prior year (and any other prior year in which
previously undiscovered errors existed) would need to be performed to
determine whether such prior year financial statements were materially
misstated. If that analysis indicates that the prior year financial
statements are materially misstated, they would need to be restated in
accordance with Statement 154.\5\
---------------------------------------------------------------------------

    \5\ Statement 154, paragraph 25.
---------------------------------------------------------------------------

    Facts: When preparing its financial statements for years ending on
or before November 15, 2006, a registrant quantified errors by using
either the iron curtain approach or the rollover approach, but not
both. Based on consideration of the guidance in this Staff Accounting
Bulletin, the registrant concludes that errors existing in previously
issued financial statements are material.
    Question 3: Will the staff expect the registrant to restate prior
period financial statements when first applying this guidance?
    Interpretive Response: The staff will not object if a registrant
\6\ does not restate financial statements for fiscal years ending on or
before November 15, 2006, if management properly applied its previous
approach, either iron curtain or rollover, so long as all relevant
qualitative factors were considered.
---------------------------------------------------------------------------

    \6\ If a registrant's initial registration statement is not
effective on or before November 15, 2006, and the registrant's prior
year(s) financial statements are materially misstated based on
consideration of the guidance in this Staff Accounting Bulletin, the
prior year financial statements should be restated in accordance
with Statement 154, paragraph 25. If a registrant's initial
registration statement is effective on or before November 15, 2006,
the guidance in the interpretive response to Question 3 is
applicable.
---------------------------------------------------------------------------

    To provide full disclosure, registrants electing not to restate
prior periods should reflect the effects of initially applying the
guidance in Topic 1N in their annual financial statements covering the
first fiscal year ending after November 15, 2006. The cumulative effect
of the initial application should be reported in the carrying amounts
of assets and liabilities as of the beginning of that fiscal year, and
the offsetting adjustment should be made to the opening balance of
retained earnings for that year. Registrants should disclose the nature
and amount of each individual error being corrected in the cumulative
adjustment. The disclosure should also include when and how each error
being corrected arose and the fact that the errors had previously been
considered immaterial.
    Early application of the guidance in Topic 1N is encouraged in any
report for an interim period of the first fiscal year ending after
November 15, 2006, filed after the publication of this Staff Accounting
Bulletin. In the event that the cumulative effect of application of the
guidance in Topic 1N is first reported in an interim period other than
the first interim period of the first fiscal year ending after November
15, 2006, previously filed interim reports need not be amended.
However, comparative information presented in reports for interim
periods of the first year subsequent to initial application should be
adjusted to reflect the cumulative effect adjustment as of the
beginning of the year of initial application. In addition, the
disclosures of selected quarterly information required by Item 302 of
Regulation S-K should reflect the adjusted results.

 [FR Doc. E6-15457 Filed 9-15-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: October 17, 2005 (Volume 70, Number 199)]
[Notices]
[Page 60313]
[DOCID:fr17oc05-47]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP05-528-001]

Dominion Cove Point LNG, LP; Notice of Compliance Filing

October 6, 2005.
    Take notice that on September 30, 2005, Dominion Cove Point LNG, LP
(Cove Point) submitted a compliance filing pursuant to the Commission's
``Order Accepting and Suspending Tariff Sheets Subject to Refund and
Conditions'' issued September 1, 2005 in Docket No. RP05-528-000.
    Cove Point states that copies of the filing were served on parties
on the official service list.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-5673 Filed 10-14-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: December 6, 2007 (Volume 72, Number 234)]
[Proposed Rules]
[Page 68763-68764]
[DOCID:fr06de07-10]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 1, 23, 25, 91, 121, 125, 135, and 139

[Docket No. FAA-2007-0152]

Takeoff/Landing Performance Assessment Aviation Rulemaking
Committee

AGENCY: Federal Aviation Administration.

ACTION: Notice and request for comments and participation.

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

SUMMARY: By this notice, the Federal Aviation Administration (FAA)
announces the formation of an Aviation Rulemaking Committee to review
regulations affecting certification and operation of airplanes and
airports for airplane takeoff and landing operations on runways
contaminated by snow, slush, ice, or standing water. This review may
also encompass related portions of other regulations, as appropriate,
and harmonization with other foreign aviation regulations. To get a
copy of the Order that established this Aviation Rulemaking Committee
go to; http://www.faa.gov/about/committees/rulemaking/. The FAA will

establish a Takeoff/Landing Performance Assessment Aviation Rulemaking
Committee to conduct this review and provide advice and recommendations
to:
    a. Establish airplane certification and operational requirements
(including training) for takeoff and landing operations on contaminated
runways.
    b. Establish landing distance assessment requirements, including
minimum landing distance safety margins, to be performed at the time of
arrival.
    c. Establish standards for runway surface condition reporting and
minimum surface conditions for continued operations.
    The FAA invites persons interested in serving on this committee or
work groups to request membership in accordance with this notice. The
FAA will select members to provide a balance of viewpoints, interests,
and expertise. The subjects of the committee meetings will be highly
technical and therefore require participants to have significant
education background, technical background, and/or work experience for
the committee to have the maximum benefit. Membership on the committee
will be limited to facilitate discussions and to maintain a balance of
interests.
    In addition, the FAA invites interested persons to submit specific,
detailed written comments, or provide input on the affected regulatory
sections. These comments will be considered in the committee
discussions and will assist in determining future regulatory action.

DATES: Membership: Persons interested in participating on the committee
or work groups should submit their request on or before January 7,
2008. Selected members will be advised in writing of their
participation and meeting details.
    Comments: The FAA will consider all comments on this regulatory
review filed on or before February 4, 2008. We will consider comments
filed late if it is possible to do so without incurring expense or
delay.

ADDRESSES: Membership: Persons requesting membership or participation
on the Takeoff/Landing Performance Assessment Aviation Rulemaking
Committee and/or associated work groups should make the request and
supply the requested information via email to the person listed below
under FOR FURTHER INFORMATION CONTACT.
    Send comments identified by Docket Number using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov
 and follow the online instructions for sending your

comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue, SE., Room W12-
140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Bring comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mr. Jerry Ostronic, AFS-200, 800
Independence Ave., SW., Washington, DC 20591, e-mail:
<EMAIL_ADDRESS>telephone:<PHONE_NUMBER> Ext. 301,

facsimile:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    The Takeoff/Landing Performance Assessment ARC will provide a forum
for the U.S. aviation community to discuss incorporating the
recommended actions identified in Safety Alert for Operators (SAFO)
06012 into the regulatory requirements. Additionally, adding regulatory
requirements for takeoff operations from contaminated runways and
issues related to contaminated runway takeoff and landing operations
relevant to part 139, Certification of Airports, will be discussed.
These discussions will be focused on turbine powered aircraft including
both turbojet and turboprop airplanes operated under parts 121, 135,
125, and 91 subpart K.

Public Participation in the Aviation Rulemaking Committee

    Membership. The FAA invites members of the public to serve on the
Takeoff/Landing Performance Assessment Aviation Rulemaking Committee
and/or work groups. The committee will provide advice and
recommendations to the FAA to assist the agency in establishing a
regulatory framework that will address the added risk associated with
takeoff and landing operations on runways with various forms of
contamination. The committee acts solely in an advisory capacity. The
committee will discuss and present whatever input, guidance, and
recommendations it considers relevant.
    Because of the diversity and complexities of the Takeoff/Landing
Performance Assessment Aviation Rulemaking Committee issues, the
committee will be structured with a steering committee and specialized
work groups. The steering committee will consist of members selected by
the FAA representing aviation associations, industry representatives,
employee groups, FAA and other government entities, and other
participants to provide a balance of views, interests,

and expertise. Membership on the steering committee will be limited to
facilitate discussions. Priority will be given to those applicants
representing an identified part of the aviation community who are
empowered to speak for those interests.
    Additional participation is provided through the specialized work
groups. At this time, the FAA is considering the establishment of work
groups comprised of subject matter experts in the following subject
areas:

--14 CFR Part 25; Airplane Certification Takeoff and Landing
Performance
--14 CFR Part 23; Airplane Certification Takeoff and Landing
Performance
--14 CFR Part 121; Operations and training associated with takeoff and
landing performance
--14 CFR Parts 135, 125, and 91 Subpart K; Operations and training
associated with takeoff and landing performance
--14 CFR 139; Airport Certification and Operations
--Current and new technologies for reporting and disseminating aircraft
stopping capabilities on contaminated runways
--Other work groups may be established if required.

    All non-government representatives serve without government
compensation and bear all costs related to their participation on the
steering committee or work groups. Members and participants should be
available to attend all scheduled committee or work group meetings for
the duration of the review. Make your request to participate on the
steering committee or specialized work groups in writing on or before
January 7, 2008. If wishing to participate on the Takeoff/Landing
Performance Assessment Aviation Rulemaking Committee or its workgroups,
please provide the following information (preferably by e-mail):

    Name:
    Title:
    Segment(s) of the industry or organization /association you
represent:
    Organization Representing:
    Address:
    E-mail address:
    Telephone contact information:
    Specific area(s) of the committee in which you are interested in
participating:
    Description of your education, technical background, and/or work
experience in the area of the committee in which you would like to
participate:
    Number of hours you will be available to participate in
committee work per month in the first 90 days of the committee; in
the first year; and beyond the first year, if necessary; and
    Number of days per month that you are available and have the
financial capability to travel for committee activities.

    The FAA will notify all selected members and participants in
writing in advance of the first meeting.
    Comments. As noted above, persons wishing to comment on this
subject may do so until February 4, 2008. In order to provide
information to the committee, the FAA requests that commenters be
timely in their comments.
    Commenters should be as specific as possible and provide as much
detail in comments as necessary to facilitate regulatory decision
making. Comments should address the specific section of the regulation
at issue, a detailed explanation of what needs to be changed and why,
and the proposed regulatory change. Information on costs and benefits
of the proposed change are particularly helpful.
    Comments provided in response to this notice will assist the FAA
and committee in their review and deliberation.

Pamela Hamilton-Powell,
Director, Office of Rulemaking.
[FR Doc. E7-23740 Filed 12-5-07; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 205 (Wednesday, October 27, 2021)]
[Notices]
[Page 59439]
[FR Doc No: 2021-23391]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-11002; 34-93402; File No. 265-32]

SEC Small Business Capital Formation Advisory Committee

AGENCY: Securities and Exchange Commission.

ACTION: Notice of meeting.

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

SUMMARY: The Securities and Exchange Commission Small Business Capital
Formation Advisory Committee, established pursuant to Section 40 of the
Securities Exchange Act of 1934 as added by the SEC Small Business
Advocate Act of 2016, is providing notice that it will hold a public
meeting by videoconference. The public is invited to submit written
statements to the Committee.

DATES: The meeting will be held on Tuesday, November 16, 2021, from
10:00 a.m. to 2:30 p.m. (ET) and will be open to the public. Written
statements should be received on or before November 16, 2021.

ADDRESSES: The meeting will be conducted by remote means
(videoconference). Members of the public may attend the meeting by
viewing the webcast on the Commission's website at www.sec.gov. Written
statements may be submitted by any of the following methods:

Electronic Statements

     Use the Commission's internet submission form (https://www.sec.gov/rules/submitcomments.htm); or
     Send an email message to [email protected]. Please
include File Number 265-32 on the subject line; or

Paper Statements

     Send paper statements to Vanessa A. Countryman, Secretary,
Securities and Exchange Commission, 100 F Street NE, Washington, DC
20549-1090.

All submissions should refer to File No. 265-32. To help us process and
review your statement more efficiently, please use only one method. The
Commission will post all statements on the SEC's website at
www.sec.gov.
    Statements also will be available for website viewing and printing
in the Commission's Public Reference Room, 100 F Street NE, Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. (ET). All statements received will be posted without change;
we do not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly.

FOR FURTHER INFORMATION CONTACT: Julie Z. Davis, Senior Special
Counsel, Office of the Advocate for Small Business Capital Formation,
at<PHONE_NUMBER>, Securities and Exchange Commission, 100 F Street NE,
Washington, DC 20549-3628.

SUPPLEMENTARY INFORMATION: The meeting will be open to the public.
Persons needing special accommodations because of a disability should
notify the contact person listed in the section above entitled FOR
FURTHER INFORMATION CONTACT. The agenda for the meeting includes
matters relating to rules and regulations affecting small and emerging
companies and their investors under the federal securities laws.

    Dated: October 22, 2021.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2021-23391 Filed 10-26-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 80 (Tuesday, April 26, 2016)]
[Notices]
[Pages 24606-24607]
[FR Doc No: 2016-09567]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2012-0653; FRL-9944-49-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NSPS for Steel Plants: Electric Arc Furnaces
and Argon Oxygen Decarburization Vessels (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``NSPS for Steel Plants: Electric
Arc Furnaces and Argon Oxygen Decarburization Vessels (40 CFR part 60,
subparts AA and AAa) (Renewal)'' (EPA ICR No. 1060.17, OMB Control No.
2060-0038), to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.). This is a proposed extension of the ICR, which is currently
approved through April 30, 2016. Public comments were previously
requested via the Federal Register (80 FR 32116) on June 5, 2015,
during a 60-day comment period. This notice allows for an additional 30
days for public comments. A fuller description of the ICR is given
below, including its estimated burden and cost to the public. An Agency
may not conduct or sponsor and a person is not required to respond

to a collection of information unless it displays a currently valid OMB
control number.

DATES: Additional comments may be submitted on or before May 26, 2016.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2012-0653, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW., Washington, DC 20460; and (2) OMB via email
to<EMAIL_ADDRESS>Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: Owners and operators of steel plants are required to
comply with reporting and record keeping requirements for the general
provisions of 40 CFR part 60, subpart A, as well as the applicable
standards in 40 CFR part 60, subparts AA and AAa. This includes
submitting initial notifications, performance tests and periodic
reports and results, and maintaining records of the occurrence and
duration of any startup, shutdown, or malfunction in the operation of
an affected facility, or any period during which the monitoring system
is inoperative. These reports are used by EPA to determine compliance
with the standards.
    Form Numbers: None.
    Respondents/affected entities: Steel plants that produce carbon,
alloy, or specialty steels: electric arc furnaces (EAFs), argon oxygen
decarburization (AOD) vessels, and dust handling systems.
    Respondent's obligation to respond: Mandatory (40 CFR part 60
Subparts AA and AAa).
    Estimated number of respondents: 99.6 (total).
    Frequency of response: Initially, occasionally and semiannually.
    Total estimated burden: 62,000 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $6,430,000 (per year), which includes
$203,000 in both annualized capital/startup and operation & maintenance
costs.
    Changes in the Estimates: There is an increase in the total
estimated burden as currently identified in the OMB Inventory of
Approved Burdens. This increase is not due to any program changes. The
increases in burden, including number of responses, labor hours, labor
costs, and O&M costs reflect an increase in the number of respondents.
The new number of respondents accounts for the one new source that is
subject to the rule since the last ICR period. Further, this ICR
assumes existing respondents will take some time to re-familiarize
themselves with the regulatory requirements each year, which results in
an increase in the estimated labor hours and costs.

Courtney Kerwin,
Acting Director, Collection Strategies Division.
[FR Doc. 2016-09567 Filed 4-25-16; 8:45 am]
 BILLING CODE 6560-50-P