[Federal Register Volume 79, Number 227 (Tuesday, November 25, 2014)]
[Notices]
[Page 70274]
[FR Doc No: 2014-27890]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket Number NHTSA-2014-0115]

Reports, Forms, and Recordkeeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Request for public comment on extension of a currently approved
collection of information.

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SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatement of previously approved collections. This
document describes an existing collection of information for motor
vehicle tire and rim labeling requirements for which NHTSA intends to
seek renewed OMB approval.

DATES: Comments must be received on or before January 26, 2015.

ADDRESSES: Comments must refer to the docket number cited at the
beginning of this notice, and may be submitted by any of the following
methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m.
Eastern Time, Monday through Friday, except Federal Holidays.
Telephone: 1-800-647-2251.
    Instructions: All submissions must include the docket number for
this document. Please identify the collection of information for which
a comment is provided by referencing the OMB Control Number, 2127-0503.
Note that all comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477) or you may visit http://DocketsInfo.dot.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Abigail Morgan, NHTSA, 1200 New
Jersey Avenue SE., Room W43-467, NVS-122, Washington, DC 20590.
Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulation (at 5 CFR
1320.8(d)), an agency must ask for public comment on the following:
    (1) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (2) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (3) How to enhance the quality, utility, and clarity of the
information to be collected;
    (4) How to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g. permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following collection of information:
    Title: Tires and Rims Labeling.
    OMB Control Number: 2127-0503.
    Type of Request: Extension of a currently approved collection of
information.
    Form Number: This collection of information uses no standard form.
    Abstract: The labeling of motor vehicle tires and rims with the
information required by the regulations and standards benefits motor
vehicle manufacturers and consumers. Primarily, these labeling
requirements help ensure that tires are mounted on appropriate rims and
that the rims and tires are mounted on vehicles for which they were
intended. If tires and rims were not labeled, mismatching of tire and
rim sizes would likely occur, often resulting in poor tire performance.
The absence of the vehicle label specifying vehicle loads, axle loads,
and recommended tire inflation pressure would likely result in improper
tire selection by a tire dealer or vehicle owner. Mismatching of rims
and tires can greatly reduce the performance of tires, may cause tire
and rim failure, and may result in vehicle handling and stability
problems, which could result in loss of vehicle control.
    Federal Motor Vehicle Safety Standard (FMVSS) Nos. 109, 117, 119,
129, and 139 establish a fixed format for the labeling requirements to
be placed into or onto both sidewalls of tires manufactured for use on
motor vehicles. Each new tire manufacturer, brand name owner, and
retreader must use these guidelines to label each tire manufactured by
engraving tire and retreaded tire molds with the appropriate labeling
information.
    FMVSS Nos. 110 and 120 specify a fixed format for the placard
labeling requirements to be placed on each motor vehicle. In addition,
FMVSS Nos. 110 and 120 require that additional information be labeled
onto the finished rim used on vehicles covered by this standard.
    Affected Public: Business or other for profit.
    Estimated Annual Burden: 274,491 hours.
    Estimated Number of Respondents: 1,800.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.

R. Ryan Posten,
Associate Administrator for Rulemaking.
[FR Doc. 2014-27890 Filed 11-24-14; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 86, Number 140 (Monday, July 26, 2021)]
[Notices]
[Pages 40040-40041]
[FR Doc No: 2021-15848]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER21-2445-000]

Glacier Sands Wind Power, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Glacier Sands Wind Power, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 9, 2021.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.

    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: July 20, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-15848 Filed 7-23-21; 8:45 am]
BILLING CODE 6717-01-P


                          Summary of May 11, 2011, Meeting

Wells McComas Community Improvement Association

Key Yacht Club; Dundalk, MD

EPA was invited to attend this meeting to address the current status of
the Sauer Dump Site which was recently proposed to the National
Priorities List (NPL).

EPA Attendees:  Carrie Deitzel

Community Involvement Coordinator

                                Richard Rupert

			OnScene Coordinator

                                Nick Tymchenko

			Remedial Project Manager

                                Linda Miller

			State and Congressional Liaison

                                Alex Mandell

			Community Involvement Coordinator

Minutes: 7:02 P.M. – 8:28 P.M.

Attendance:

 (  The meeting began at 7:02 p.m.

(  Approximately 25 community members were in attendance.

(  Russell Donnelley from environmental group SECAP present.

(  Delegate John Olszewski present.

Meeting Overview:

Part I.

Fred Theiss, the community group president, began the meeting by
thanking the EPA for coming a long way to be part of the day’s
discussion. Mr. Theiss addressed those in attendance and provided a
brief background of Sauer Dump, including the fact that many of the
members’ children had grown up playing and dirt biking at the site.
He mentioned a public meeting, held by EPA in 2009, at the Sparrows
Point Middle School.  The meeting was held during a public comment
period on an EPA Engineering Evaluation/Cost Analysis (EE/CA) report
that described four potential options to deal with the contamination at
Sauer Dump.  Mr. Thiess recalled that Option 4 was the most thorough
option and the one attendees of the meeting at the school seemed to
favor. He also reminded those present at the yacht club that the Sauer
Dump Site had been proposed for listing on the NPL. He mentioned that a
comment period was open and told everyone that they could submit
comments until the comment period closes.  He stated that the comment
period was scheduled to close on May 9th, and that a request from
Senator Mikulski to extend the comment period to May 16th was granted.
In the conclusion of Mr. Theiss’s opening remarks he introduced Carrie
Deitzel to further clarify and provide more information on the EPA’s
involvement with the Site.

Part II.

Carrie introduced herself as the site EPA Community Involvement
Coordinator and gave a brief site history of Sauer Dump emphasizing,
very briefly, activities by the state and the EPA since the mid 1990s.
She distributed a fact sheet that gave instructions for submitting
comments on the proposal to list Sauer Dump on the NPL and provided the
new comment period closing date.  She also distributed a chart of the
generic Superfund process.

Carrie explained what the National Priorities List is and spoke about
the comment period, and the importance of submitting comments to the HQ
Docket Coordinator.  She explained that while EPA was taking notes of
the evening’s meeting which would be placed in the docket file, the
notes would not count as individual comments.  Those wishing to make
official comments would need to follow the comment instructions provided
on the handout.  She explained how it is desirable for individuals to
submit comments and that their comments can influence the outcome of the
comment period, just as the comments received during the comment period
for the 2009 EE/CA had affected the outcome then. Carrie explained that
being listed on the NPL can ensure that a thorough investigation is
conducted and that the eventual remedy may result in a more stringent
resolution of the site problems. Carrie touched on the fact that the
Superfund law requires that community members be provided opportunities
to be involved in site activities throughout the Superfund process.  She
spoke about different opportunities to get involved and mentioned how
services are provided under the different options, including: Community
Advisory Groups (CAGs), Technical Assistance Services for Communities
(TASC), and Technical Assistance Grants (TAGs).  She encouraged people
to contact her if they are interested in obtaining technical assistance
services in the future.

Carrie introduced Richard Rupert, Linda Miller, and Nick Tymchenko, and
described their responsibilities. Rich discussed the history of the
site, briefly, and identified the contaminants of concern at the site.
He explained EPA’s involvement at the site since he became involved in
2005 and discussed the 2009 EE/CA which was performed by contractors
under his oversight.  He mentioned that the alternative that EPA was
considering was not the alternative preferred by the public or the
state.  The EE/CA did not include an ecological risk assessment and
focused mainly on the human health threat posed by the site.  Rich and
Carrie explained that the current comment period concerns whether the
site should be placed on the NPL and stated that the past EE/CA remedy
options are no longer under consideration.

Part III.

Questions and comments were made, informally, throughout the meeting and
presentation.  (In the following list, CM refers to a community member.
The questions are not actual quotations)

CM: Does public response really mean anything during a comment period?

EPA:  Comments must be considered before a final decision is made. The
comments received can be seen on the Internet in the docket (web address
was provided in a fact sheet distributed in March.  Copies were
available at this meeting.) and EPA will prepare a summary of responses
at the end of the period which will also be made available online.
Comments are very important and can be influential.

CM: Are the comments made in the past (2009) reviewed?

EPA:  Comments made then cannot be expected to be transferred and
considered as comments for this comment period.  If you want to comment
on the proposal to list this site on the NPL, you must submit comments
before this comment period closes by the means described on the handout
you got tonight.

CM:  The instructions for commenting say you must send 3 copies of your
comment.  Does that mean if I comment by e-mail, I have to send 3
e-mails?

EPA: No, the 3 copies refer only to the method where that statement
appears on the instruction sheet.

CM: When I submit comments on the proposal, should I also say which
cleanup option I prefer?

EPA:  No.  This comment period only pertains to you want to see the site
placed on the NPL or not.  The cleanup options presented in the EE/CA
are no longer on the table.  If the site is listed on the NPL, when the
RI and the Feasibility Study(FS) are released, new cleanup options will
be presented and the community will have an opportunity to comment on
them at that time.

CM: What happens next?

EPA:   Currently, the Remedial Program is reviewing the data collected,
to date, to identify any data gaps that need to be addressed during the
RI. During the RI, EPA will conduct a Human Health Assessment and an
Ecological Risk Assessment and gather additional date.  When the RI and
FS are completed, a Proposed Plan will be developed to describe
available cleanup options and a public comment period will be held
before a remedy is selected.  But be aware the remedial process is not a
fast process. The first opportunity for the site to be placed on the NPL
will be in September or October, but depending on the number and
complexity of comments, a decision may not be made at that time.

CM: If the PRP’s do not agree to do the clean up, could the EPA take
action?

EPA:  EPA could order the PRPs to do the work or EPA can do the work and
then sue the PRPs for up to three times the cost of cleanup.  That is
usually incentive for the PRPs to comply with an order to do the
cleanup.  The EPA oversees the work and it must achieve the cleanup
goals established by EPA for the site.

CM:  What if the site does not get on the NPL?

EPA:  Generally, responsibility for the site, then, goes back to the
State and local government authorities.

CM: I remember the Kane & Lombard Street Drum Site. That got cleaned up
pretty well. It even has a golf course on it. Is that what we are to
expect here?

EPA:  Our goal at EPA is to see beneficial reuse of a site when the
cleanup is done. EPA doesn’t fund site redevelopment but we do support
it and make it known when a site is ready for reuse.  From EPA’s
perspective, beneficial reuse could be light industry or residential
development, but it can also be open space and habitat restoration,
which may be a good fit for this site.

CM:  At some point, will the community have a clear timeline for the
site cleanup?

EPA:  It is very difficult to provide a specific timeline for a remedial
investigation and cleanup.  There are many things that affect the
schedule.  Sometimes, negotiations with PRPs cause delays.  When we need
access to private properties to do work, that can cause delays, as can
severe weather, and many other things.  The remedial process is slow.
But as the process unfolds, there will be project schedule projections,
and we will hold a public meeting after the site is listed to discuss
the RI process.

Conclusion:

Mr. Theiss thanked the EPA representatives for attending the meeting.
Carrie reminded them to contact her if they were interested in
discussing community involvement support services.


[Federal Register Volume 85, Number 175 (Wednesday, September 9, 2020)]
[Rules and Regulations]
[Page 55587]
[FR Doc No: 2020-19569]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

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

Federal Register / Vol. 85, No. 175 / Wednesday, September 9, 2020 /
Rules and Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2014-N-1021]
RIN 0910-AH00

Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed
Foods; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: The Food and Drug Administration (FDA or we) is correcting a
final rule that published in the Federal Register of August 13, 2020.
The final rule establishes requirements concerning ``gluten-free''
labeling for foods that are fermented or hydrolyzed or that contain
fermented or hydrolyzed ingredients.

DATES: Effective October 13, 2020.

FOR FURTHER INFORMATION CONTACT: Carol D'Lima, Center for Food Safety
and Applied Nutrition (HFS-820), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Federal Register of Thursday, August
13, 2020, (85 FR 49240), FDA published the final rule ``Food Labeling;
Gluten-Free Labeling of Fermented or Hydrolyzed Foods'' with a
typographical error in the SUMMARY section. In addition, the rule was
published with two different effective dates.
    In FR Doc. 2020-17088, appearing in the Federal Register of
Thursday, August 13, 2020, the following corrections are made:
    On page 49241, in the first column, the second sentence is
corrected to read as follows: ``These requirements are needed to help
ensure that individuals with celiac disease are not misled and receive
truthful and accurate information with respect to fermented or
hydrolyzed foods labeled as `gluten-free.'''
    On page 49254, in section VI. Effective and Compliance Dates, in
the first column, the first sentence is corrected to read as follows:
``This rule is effective October 13, 2020.'' This confirms the rule is
effective October 13, 2020, and is consistent with the effective date
stated earlier on page 49241.

    Dated: August 31, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-19569 Filed 9-4-20; 4:15 pm]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Page 56638]
[FR Doc No: 2022-19926]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER22-2800-000]

VESI 24 LLC; Supplemental Notice That Initial Market-Based Rate
Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
VESI 24 LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is September 28, 2022.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: September 8, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-19926 Filed 9-14-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 240 (Thursday, December 13, 2012)]
[Notices]
[Page 74182]
[FR Doc No: 2012-30068]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR13-14-000]

Magic Valley Pipeline, L.P.; Notice of Petition for Rate Approval

    Take notice that on November 30, 2012, Magic Valley Pipeline, L.P.
(Magic Valley) filed a petition for rate approval pursuant to section
284.123(b)(2) of the Commission's regulations for approval of a new
rate applicable to firm transportation service, as more fully detailed
in the petition.
    Any person desiring to participate in this rate filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests 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. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 7 copies of the protest or intervention 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 email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on Friday, December 14, 2012.

    Dated: December 07, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-30068 Filed 12-12-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 175 (Wednesday, September 9, 2020)]
[Notices]
[Pages 55678-55682]
[FR Doc No: 2020-19883]

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

Food and Drug Administration

[Docket Nos. FDA-2020-D-1106 and FDA-2020-D-1138]

Guidance Documents Related to Coronavirus Disease 2019;
Availability

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

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of FDA guidance documents related to the Coronavirus
Disease 2019 (COVID-19) public health emergency (PHE). This notice of
availability (NOA) is pursuant to the process that FDA announced, in
the Federal Register of March 25, 2020, for making available to the
public COVID-19-related guidances. The guidances identified in this
notice address issues related to the COVID-19 PHE and have been issued
in accordance with the process announced in the March 25, 2020, notice.
The guidance documents have been implemented without prior comment, but
they remain subject to comment in accordance with the Agency's good
guidance practices.

DATES: The announcement of the guidances is published in the Federal
Register on September 9, 2020. The guidances have been implemented
without prior comment, but they remain subject to comment in accordance
with the Agency's good guidance practices.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

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 name of the
guidance document that the comments address and the docket number for
the guidance (see table 1). Received comments will be placed in the
docket(s) 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>.
    You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
    Submit written requests for single copies of these guidances to the
address noted in table 1. Send two self-addressed adhesive labels to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Kimberly Thomas, Center for Drug
Evaluation and Research (CDER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-
796-2357; or Erica Takai, Center for Devices and Radiological Health
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5456, (HFZ-450), Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, Alex
M. Azar II, Secretary of Health and Human Services, pursuant to the
authority under section 319 of the Public Health Service Act (PHS Act),
determined that a PHE exists and has existed since January 27, 2020,
nationwide.\1\ On March 13, 2020, President Donald J. Trump declared
that the COVID-19 outbreak in the United States constitutes a national
emergency, beginning March 1, 2020.\2\
---------------------------------------------------------------------------

    \1\ On April 21, 2020, the PHE Determination was extended,
effective April 26, 2020; on July 23, 2020, it was extended again,
effective July 25, 2020. These PHE Determinations are available at
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
    \2\ Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020),
available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
---------------------------------------------------------------------------

    In the Federal Register of March 25, 2020 (the March 25, 2020,
notice) (available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), FDA announced procedures for making available
FDA guidance documents related to the COVID-19 PHE. These procedures,
which operate within FDA's established good guidance practices
regulations, are intended to allow FDA to rapidly disseminate Agency
recommendations and policies related to COVID-19 to industry, FDA
staff, and other stakeholders. The March 25, 2020, notice stated that
due to the need to act quickly and efficiently to respond to the COVID-
19 PHE, FDA believes that prior public participation will not be
feasible or appropriate before FDA implements COVID-19-related guidance
documents. Therefore, FDA will issue COVID-19-related guidance
documents for immediate implementation without prior public comment
(see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 371(h)(1)(C) and Sec.  10.115(g)(2). The
guidances are available at FDA's web page titled ``COVID-19-Related
Guidance Documents for Industry, FDA Staff, and Other Stakeholders''
(https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and through FDA's web page titled ``Search for FDA
Guidance Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
    The March 25, 2020, notice further stated that, in general, rather
than publishing a separate NOA for each COVID-19-related guidance
document, FDA intends to publish periodically a consolidated NOA
announcing the availability of certain COVID-19-related guidances FDA
issued during the relevant period, as included in table 1. This notice
announces COVID-19-related guidances that are posted on FDA's website.

II. Availability of COVID-19-Related Guidance Documents

    Pursuant to the process described in the March 25, 2020, notice,
FDA is announcing the availability of the following COVID-19-related
guidances:

                       Table 1--Guidances Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
                                                                                Contact information to
            Docket No.                      Center              Title of guidance        request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1106...................  Center for Drug        Temporary Policy for<EMAIL_ADDRESS>                                     Evaluation and         Preparation of Certain      Please include the
                                     Research (CDER).       Alcohol-Based Hand          docket number FDA-2020-D-
                                                            Sanitizer Products During   1106 and complete title
                                                            the Public Health           of the guidance in the
                                                            Emergency (COVID-19)        request.
                                                            (March 2020) (Updated
                                                            August 7, 2020).
FDA-2020-D-1106...................  CDER.................  Policy for Temporary<EMAIL_ADDRESS>                                                            Compounding of Certain      Please include the
                                                            Alcohol-Based Hand          docket number FDA-2020-D-
                                                            Sanitizer Products During   1106 and complete title
                                                            the Public Health           of the guidance in the
                                                            Emergency (March 2020)      request.
                                                            (Updated August 7, 2020).

FDA-2020-D-1106...................  CDER.................  Temporary Policy for<EMAIL_ADDRESS>                                                            Manufacture of Alcohol      Please include the
                                                            for Incorporation Into      docket number FDA-2020-D-
                                                            Alcohol-Based Hand          1106 and complete title
                                                            Sanitizer Products During   of the guidance in the
                                                            the Public Health           request.
                                                            Emergency (COVID-19)
                                                            (March 2020) (Updated
                                                            August 7, 2020).
FDA-2020-D-1138...................  Center for Devices     Enforcement Policy for      CDRH-
                                     and Radiological       Viral Transport Media       [email protected],
                                     Health (CDRH).         During the Coronavirus      Please include the
                                                            Disease 2019 (COVID-19)     document number 20038
                                                            Public Health Emergency     and complete title of
                                                            (July 2020).                the guidance in the
                                                                                request.
----------------------------------------------------------------------------------------------------------------

    Although these guidances have been implemented immediately without
prior comment, FDA will consider all comments received and revise the
guidances as appropriate (see Sec.  10.115(g)(3)).
    These guidances are being issued consistent with FDA's good
guidance practices regulation (Sec.  10.115). The guidances represent
the current thinking of FDA. They do not establish any rights for any
person and are not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

III. Paperwork Reduction Act of 1995

A. CDER Guidances

    The guidances listed in the table below refer to previously
approved collections of information. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521).
The collections of information in the following FDA regulations and
guidances have been approved by OMB as listed in the table below. These
guidances also contain a collection of information not approved under a
current collection. This collection of information has been granted a
PHE waiver from the PRA by the Department of Health and Human Services
(HHS) on March 19, 2020, under section 319(f) of the PHS Act.
Information concerning the PHE PRA waiver can be found on the HHS
website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

                                     Table 2--CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                           CFR cite(s)
      COVID-19 guidance title        referenced in COVID-19  Another guidance referenced    OMB Control  No(s).
                                             guidance            in COVID-19 guidance
----------------------------------------------------------------------------------------------------------------
Temporary Policy for Preparation of  27 CFR parts 20 and 21  --Policy for Temporary       0910-0045, 0910-0139,
 Certain Alcohol-Based Hand                                   Compounding of Certain       0910-0230, 0910-0291,
 Sanitizer Products During the                                Alcohol-Based Hand           0910-0340, 0910-0641,
 Public Health Emergency (COVID-                              Sanitizer Products During    0910-0645, 0910-0800.
 19)--UPDATE of guidance announced                            the Public Health
 in March 2020.                                               Emergency.
                                                             --Temporary Policy for
                                                              Manufacture of Alcohol for
                                                              Incorporation Into Alcohol-
                                                              Based Hand Sanitizer
                                                              Products During the Public
                                                              Health Emergency (COVID-
                                                              19).
                                                             --Providing Regulatory
                                                              Submissions in Electronic
                                                              Format--Drug Establishment
                                                              Registration and Drug
                                                              Listing.
                                                             --Postmarketing Adverse
                                                              Event Reporting for
                                                              Nonprescription Human Drug
                                                              Products Marketed Without
                                                              an Approved Application.
Temporary Policy for Manufacture of  27 CFR parts 20 and 21  --Policy for Temporary       0910-0045, 0910-0139,
 Alcohol for Incorporation Into                               Compounding of Certain       0910-0230, 0910-0291,
 Alcohol-Based Hand Sanitizer                                 Alcohol-Based Hand           0910-0340, 0910-0641,
 Products During the Public Health                            Sanitizer Products During    0910-0645.
 Emergency (COVID-19)--UPDATE of                              the Public Health
 guidance announced in March 2020.                            Emergency.
                                                             --Temporary Policy for
                                                              Preparation of Certain
                                                              Alcohol-Based Hand
                                                              Sanitizer Products During
                                                              the Public Health
                                                              Emergency (COVID-19).
                                                             --Providing Regulatory
                                                              Submissions in Electronic
                                                              Format--Drug Establishment
                                                              Registration and Drug
                                                              Listing.

Policy for Temporary Compounding of  ......................  --Current Good               0910-0045, 0910-0139,
 Certain Alcohol-Based Hand                                   Manufacturing Practices      0910-0230, 0910-0291,
 Sanitizer Products During the                                for Finished                 0910-0340, 0910-0641,
 Public Health Emergency--UPDATE of                           Pharmaceuticals and          0910-0645.
 guidance announced in March 2020.                            Medical Gases.
                                                             --Postmarketing Adverse
                                                              Drug Experience Reporting..
                                                             --MedWatch: Adverse Event
                                                              and Product Experience
                                                              Reporting System (Paper-
                                                              Based).
                                                             --Format and Content
                                                              Requirements for Over-the-
                                                              Counter Drug Product
                                                              Labeling.
                                                             --FDA Adverse Event and
                                                              Product Experience
                                                              Reports; Electronic
                                                              Submissions.
                                                             --Adverse Event Reporting
                                                              for Outsourcing Facilities
                                                              Under Section 503B of the
                                                              Federal Food, Drug, and
                                                              Cosmetic Act.
                                                             --Temporary Policy for
                                                              Preparation of Certain
                                                              Alcohol-Based Hand
                                                              Sanitizer Products During
                                                              the Public Health
                                                              Emergency (COVID-19).
                                                             --Temporary Policy for
                                                              Manufacture of Alcohol for
                                                              Incorporation Into Alcohol-
                                                              Based Hand Sanitizer
                                                              Products During the Public
                                                              Health Emergency (COVID-
                                                              19).
----------------------------------------------------------------------------------------------------------------

B. CDRH Guidances

    The guidance indicated in the table below refers to previously
approved collections of information. These collections of information
are subject to review by the OMB under the PRA. The collections of
information in the following FDA regulations and guidance have been
approved by OMB as listed in the table below. This guidance also
contains a new collection of information not approved under a current
collection. This new collection of information has been granted a PHE
waiver from the PRA by HHS on March 19, 2020, under section 319(f) of
the PHS Act. Information concerning the PHE PRA waiver can be found on
the HHS website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

                                     Table 3--CDRH Guidances and Collections
----------------------------------------------------------------------------------------------------------------
                                    CFR cites(s)      Another guidance                           New collection
    COVID-19 guidance title        referenced  in      referenced  in     OMB Control  No(s).   covered by  PHE
                                  COVID-19 guidance   COVID-19 guidance                            PRA waiver
----------------------------------------------------------------------------------------------------------------
Enforcement Policy for Viral                         Emergency Use       0910-0595             .................
 Transport Media During the                           Authorization of
 Coronavirus Disease 2019                             Medical Products
 (COVID-19) Public Health                             and Related
 Emergency (July 2020).                               Authorities;
                                                      Guidance for
                                                      Industry and
                                                      Other
                                                      Stakeholders.
                                                     Administrative      0910-0607             .................
                                                      Procedures for
                                                      Clinical
                                                      Laboratory
                                                      Improvement
                                                      Amendments of
                                                      1988
                                                      Categorization.
                                 21 CFR parts 800,   ..................  0910-0485             .................
                                  801, and 809.
                                 21 CFR part 803...  ..................  0910-0437             .................
                                 21 CFR part 806...  ..................  0910-0359             .................
                                 21 CFR part 807,    ..................  0910-0625             .................
                                  subparts A
                                  through D.
                                 21 CFR part 807,    ..................  0910-0120             .................
                                  subpart E.
                                 21 CFR part 820...  ..................  0910-0073             .................
                                 21 CFR part 830     ..................  0910-0720             .................
                                  and 21 CFR 801.20.
                                                                                Manufacturer
                                                                                voluntary
                                                                                reporting to FDA
                                                                                of viral
                                                                                transport media
                                                                                manufacturing
                                                                                capacity
                                                                                information.
                                                                                Manufacturer
                                                                                voluntary
                                                                                reporting to FDA
                                                                                of sterile
                                                                                phosphate
                                                                                buffered saline/
                                                                                saline
                                                                                manufacturing
                                                                                capacity
                                                                                information.
----------------------------------------------------------------------------------------------------------------

IV. Electronic Access

    Persons with access to the internet may obtain COVID-19-related
guidances at:
     The FDA web page entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,'' available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders;
     the FDA web page entitled ``Search for FDA Guidance
Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
     https://www.regulations.gov.

    Dated: September 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-19883 Filed 9-8-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: May 12, 2008 (Volume 73, Number 92)]
[Notices]
[Page 26985-26986]
[DOCID:fr12my08-32]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2007-0063; FRL-8564-4]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Primary Copper
Smelters (Renewal), EPA ICR Number 1850.05, OMB Control Number 2060-
0476

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before June 11, 2008.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2007-0063, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by e-mail to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
2201T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2) OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street,
NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Compliance Assessment
and Media Programs Division, Office of Compliance, Mail Code 2223A,
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On March 9, 2007 (72 FR 10735), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2007-0063, which is available for public viewing
online at http://www.regulations.gov, in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted either electronically or in paper, will be
made available for public viewing at http://www.regulations.gov, as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: NESHAP for Primary Copper Smelters (Renewal).
    ICR Numbers: EPA ICR Number 1850.05, OMB Control Number 2060-0476.
    ICR Status: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Primary Copper Smelters were proposed on April
20, 1998 (63 FR 19582), and June 26, 2000 (65 FR 39326) respectively.
These standards apply to any existing, reconstructed, or new primary
copper smelters. The affected sources are each copper concentrate
dryer, each smelting furnace, slag cleaning vessel, each copper
converter department, and the entire group of fugitive emission
sources.
    Abstract: Affected owners and operators are required to meet
specific monitoring, recordkeeping, and reporting requirements in order
to demonstrate initial and continuous compliance with the rule. A
primary copper smelter is only subject to the regulation if it is a
major source of hazardous air pollutant (HAP) emitting or has the
potential to emit any single HAP at the rate of 10 tons or more per
year or any combination of HAP at the rate of 25 tons or more per year.
    Owners and operators must submit notification reports upon the
construction, reconstruction, or modification of any primary copper
smelter. Also, required is a one-time-only initial notification for new
and reconstructed sources. The respondents are required to submit an
annual performance test for each control device, and a semiannual
summary report to EPA. Respondents subject to the final rule are
required to prepare and maintain on site two site-specific operating
plans: (1) A startup, shutdown, malfunction plan, and (2) a fugitive
dust control plan. Owners or operators of primary copper smelters
facilities subject to the rule must maintain a file of these
measurements, and retain the file for at least five years following the
date of such measurements, maintenance reports, and records.
    Notifications are to inform the Agency or delegated authority when
a source becomes subject to the standard. The reviewing authority may
then inspect the source to check if the pollution control devices are
properly installed and operating and the standards are being met.
Performance test reports are required as these are the Agency's records
of a source's initial capability to comply with the emission standards
and to serve as a record of the operating conditions under which
compliance is to be achieved. The information generated by monitoring,
recordkeeping and reporting requirements described in this ICR is used
by the Agency to ensure that facilities affected by the standard
continue to operate the control equipment and achieve continuous
compliance with the regulation.
    All reports are sent to the delegated state or local authority. In
the event that there is no such delegated authority, the reports are
sent directly to the EPA regional office. This information is being
collected to assure compliance with 40 CFR part 63, subpart QQQ, as
authorized in sections 112 and 114(a) of the Clean Air Act. The
required information consists of emissions data and other information
that have been determined to be private.

    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. The OMB Control Number for EPA's
regulations listed in 40 CFR part 9 and 48 CFR chapter 15, are
identified on the form and/or instrument, if applicable.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 196
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose and provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information. All
existing ways will have to adjust to comply with any previously
applicable instructions and requirements that have subsequently
changed; train personnel to be able to respond to a collection of
information; search data sources; complete and review the collection of
information; and transmit or otherwise disclose the information.
    Respondents/Affected Entities: Primary copper smelters.
    Estimated Number of Respondents: 3.
    Frequency of Response: Monthly, semiannually, annually, and
initially.
    Estimated Total Annual Hour Burden: 8,837.
    Estimated Total Annual Cost: $575,068, including $8,220 for
operation and maintenance (O&M) costs, $566,848 for labor costs, and
zero for capital/startup costs.
    Changes in the Estimates: There is no change in the labor hours or
cost in this ICR compared to the previous ICR. This is due to two
considerations: (1) The regulations have not changed over the past
three years and are not anticipated to change over the next three
years; and (2) the growth rate for the industry is very low, negative
or non-existent, so there is no significant change in the overall
burden. It should be noted that the previous ICR rounded the burden
cost down to the nearest one thousand. In this ICR, the exact cost
figure is reported which results in an apparent increase in the cost
when, in fact, no increase has occurred. Also, a mathematical error in
the labor cost burden was corrected.
    Since there are no changes in the regulatory requirements and there
is no significant industry growth, the labor hours and cost figures in
the previous ICR are used in this ICR, and there is no change in burden
to industry.

    Dated: April 30, 2008.
Sara Hisel-McCoy,
Director, Collection Strategies Division.
 [FR Doc. E8-10507 Filed 5-9-08; 8:45 am]

BILLING CODE 6560-50-P