[Federal Register Volume 77, Number 197 (Thursday, October 11, 2012)]
[Notices]
[Page 61774]
[FR Doc No: 2012-25031]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4082-DR; Docket ID FEMA-2012-0002]

Alabama; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Alabama (FEMA-4082-DR), dated September 21, 2012, and
related determinations.

DATES:  Effective Date: October 3, 2012.

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

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Alabama is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of September 21, 2012.

    Covington, Dallas, Geneva, Monroe, and Perry Counties for Public
Assistance.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2012-25031 Filed 10-10-12; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 78, Number 53 (Tuesday, March 19, 2013)]
[Notices]
[Page 16845]
[FR Doc No: 2013-06204]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP13-92-000]

Gulf South Pipeline Company, LP; Notice of Application

    Take notice that on March 1, 2013, Gulf South Pipeline Company, LP
(Gulf South), filed in Docket No. CP13-92-000, an application pursuant
to section 7(b) of the Natural Gas Act (NGA) and Part 157 of the
Commission's regulations, requesting authorization to abandon by sale
to an affiliated company, Boardwalk Mississippi Intrastate Pipeline
Company, LLC, approximately 511 miles of low/lower-pressure pipeline,
consisting of 479 miles of transmission pipeline and 32 miles of
gathering pipeline, associated meters, and appurtenant and auxiliary
facilities located in Mississippi, all as more fully set forth in the
application which is on file with the Commission and open to public
inspection. This filing may also be viewed on the Commission's Web site
at 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. For assistance, call<PHONE_NUMBER> or TTY, (202)
502-8659.
    Any questions regarding this application should be directed to Mr.
J. Kyle Stephens, Vice-President, Regulatory Affairs, Gulf South
Pipeline Company, LP, 9 Greenway Plaza, Suite 2800, Houston, Texas,
77046, or by calling<PHONE_NUMBER> (telephone) or<PHONE_NUMBER> (fax)
<EMAIL_ADDRESS>    Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
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 14 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    Comment Date: April 2, 2013.

    Dated: March 12, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-06204 Filed 3-18-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23123-23125]
[FR Doc No: 2017-10132]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80677; File No. SR-NYSE-2017-20]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing of Proposed Rule Change Amending Its Listing Standard
for Special Purpose Acquisition Companies To Change Shareholder Vote
Requirement for the Approval of a Business Combination

May 15, 2017.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that, on May 1, 2017, New York Stock Exchange LLC (``NYSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its listing standard for Acquisition
Companies (``ACs'') to change its shareholder vote requirement for the
approval of a Business Combination. The proposed rule change is
available on the Exchange's Web site at www.nyse.com, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to amend its listing standard for Acquisition
Companies (or ``ACs'') as set forth in Section 102.06 of the NYSE
Listed Company Manual (the ``Manual'') to change its shareholder vote
requirement for the approval of a Business Combination.
    An AC (typically known in the marketplace as a special purpose
acquisition company or ``SPAC'') is a special purpose company formed
for the purpose of effecting a merger, capital stock exchange, asset
acquisition, stock purchase, reorganization or similar business
combination with one or more operating businesses or assets with a fair
market value equal to at least 80% of the net assets of the AC held in
trust (net of amounts disbursed to management for working capital
purposes and excluding the amount of any deferred underwriting discount
held in trust) (a ``Business Combination'').
    Section 102.06 subjects any AC listed on the NYSE to the following
requirements (among others):
     If the AC holds a shareholder vote on a Business
Combination, it must be approved by a majority of the votes cast by
public shareholders \4\ at the shareholder meeting at which the
Business Combination is being considered;
---------------------------------------------------------------------------

    \4\ Shares held by directors, officers, or their immediate
families and other concentrated holding of 10 percent or more are
excluded in calculating the number of publicly-held shares.
---------------------------------------------------------------------------

     if a shareholder vote on a Business Combination is held,
each public shareholder voting against the Business Combination will
have the right to convert its shares of common stock into a pro rata
share of the aggregate amount then on deposit in the trust account (net
of taxes payable, and amounts disbursed to management for working
capital purposes), provided that the Business Combination is approved
and consummated; \5\
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    \5\ An AC can establish a limit (set no lower than 10% of the
shares sold in the AC's IPO) as to the maximum number of shares with
respect to which any public shareholder, together with any affiliate
of such shareholder or any person with whom such shareholder is
acting as a ``group'' (as such term is used in Sections 13(d) and
14(d) of the Exchange Act) may exercise conversion rights;

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

     if a shareholder vote is not held on a Business
Combination for which the company must file and furnish a proxy or
information statement subject to Regulation 14A or 14C under the
Exchange Act, the company must provide all shareholders with the
opportunity to redeem all their shares for cash equal to their pro rata
share of the aggregate amount then in the deposit account (net of taxes
payable, and amounts disbursed to management for working capital
purposes), pursuant to Rule 13e-4 and Regulation 14E under the Exchange
Act, which regulates issuer tender offers; and
     the AC will be liquidated if no Business Combination has
been consummated within a specified time period not to exceed three
years.
    The Exchange proposes to amend Section 102.06 by modifying its
requirement that a shareholder vote approving a Business Combination be
approved by a majority of the votes cast by public shareholders. The
proposed amended rule would require approval by a majority of all votes
cast on the proposal, rather than just votes cast by public
shareholders. The Exchange notes that the proposed revision to the
voting requirements would conform the NYSE's rule to the comparable
requirements under the SPAC listing standards of the NASDAQ Stock
Market and NYSE MKT.\6\ Harmonizing the Exchange's requirements with
those of the other listing markets will enable it to compete more
effectively for the listing of ACs. The Exchange believes that the
proposed amended rule would be consistent with the protection of
investors, as any investor who voted against a proposed Business
Combination would continue to have the right to require the company to
redeem such investor's shares for cash if the Business Combination was
consummated.
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    \6\ See NASDAQ IM 5101-2 and Section 119 of the MKT Company
Guide.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\7\ in general, and furthers the
objectives of Section 6(b)(5) \8\ of the Act, in particular in that it
is designed to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest
and is not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed amended rule is consistent
with the protection of investors because as any investor [sic] who
voted against a proposed Business Combination would continue to have
the right to require the company to redeem such investor's shares for
cash if the Business Combination was consummated. In addition, the
Exchange notes that the proposed revision to the voting requirements
would conform the NYSE's rules to the comparable requirements under the
SPAC listing standards of the NASDAQ Stock Market and NYSE MKT.
Harmonizing the Exchange's requirements with those of the other listing
markets will enable it to compete more effectively for the listing of
ACs.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
designed to harmonize the Exchange's requirements with respect to the
listing of ACs with those of the other listing exchanges and will
therefore increase competition for the listing of ACs by making the
Exchange a more attractive listing venue.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or up to 90 days (i) as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or (ii) as to which the self-regulatory
organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2017-20 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSE-2017-20. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2017-20 and should be
submitted on or before June 9, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-10132 Filed 5-18-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 185 (Tuesday, September 24, 2019)]
[Notices]
[Pages 50039-50041]
[FR Doc No: 2019-20669]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0797]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Human Tissue Intended for Transplantation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements relating to FDA regulations for human tissue intended for
transplantation.

DATES: Submit either electronic or written comments on the collection
of information by November 25, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 25, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 25, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

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

    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0797 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Human Tissue Intended for
Transplantation.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.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.

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<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Human Tissue Intended for Transplantation--21 CFR Part 1270

OMB Control Number 0910-0302--Extension

    Under section 361 of the Public Health Services Act (42 U.S.C.
264), FDA issued regulations under part 1270 (21 CFR part 1270) to
prevent the transmission of human immunodeficiency virus, hepatitis B,
and hepatitis C, through the use of human tissue for transplantation.
The regulations provide for inspection by FDA of persons and tissue
establishments engaged in the recovery, screening, testing, processing,
storage, or distribution of human tissue. These facilities are required
to meet provisions intended to ensure appropriate screening and testing
of human tissue donors and to ensure that records are kept documenting
that the appropriate screening and testing have been completed.
    Section 1270.31(a) through (d) requires written procedures to be
prepared and followed for the following steps: (1) All significant
steps in the infectious disease testing process under Sec.  1270.21;
(2) all significant steps for obtaining, reviewing, and assessing the
relevant medical records of the donor as prescribed in Sec.  1270.21;
(3) designating and identifying quarantined tissue; and (4) for
prevention of infectious disease contamination or cross-contamination
by tissue during processing. Sections 1270.31(a) and (b) also requires
recording and justification of any deviation from the written
procedures. Section 1270.33(a) requires records to be maintained
concurrently with the performance of each significant step required in
the performance of infectious disease screening and testing of human
tissue donors. Section 1270.33(f) requires records to be retained
regarding the determination of the suitability of the donors and of the
records required under Sec.  1270.21. Section 1270.33(h) requires all
records to be retained for at least 10 years beyond the date of
transplantation if known, distribution, disposition, or expiration of
the tissue, whichever is the latest. Section 1270.35(a) through (d)
requires specific records to be maintained to document the following:
(1) The results and interpretation of all required infectious disease
tests; (2) information on the identity and relevant medical records of
the donor; (3) the receipt and/or distribution of human tissue, and (4)
the destruction or other disposition of human tissue.
    Respondents to this collection of information are manufacturers of
human tissue intended for transplantation. Based on information from
the Center for Biologics Evaluation and Research's (CBER's) database
system, we estimate 383 tissue establishments, of which 262 are
conventional tissue banks and 121 are eye tissue banks. Based on
information provided by industry, we estimate a total of 2,141,960
conventional tissue products, and 130,987 eye tissue products
distributed per year with an average of 25 percent of the tissue
discarded due to unsuitability for transplant. In addition, we estimate
29,799 deceased donors of conventional tissue and 70,027 deceased
donors of eye tissue each year.
    Accredited members of the American Association of Tissue Banks
(AATB) and Eye Bank Association of America (EBAA) adhere to standards
of those organizations that are comparable to the recordkeeping
requirements in part 1270. Based on information included in

CBER's database system, 90 percent of the conventional tissue banks are
members of AATB (262 x 90 percent = 236), and 95 percent of eye tissue
banks are members of EBAA (121 x 95 percent = 115). Therefore, we
exclude burden for recordkeeping by these 351 establishments (236 + 115
= 351) from our estimate as we believe such recordkeeping is usual and
customary business activity (5 CFR 1320.3(b)(2)). The recordkeeping
burden, thus, is estimated for the remaining 32 establishments, which
is 8.36 percent of all establishments (383 - 351 = 32, or 32/383 = 8.36
percent).
    We assume that all current tissue establishments have developed
written procedures in compliance with part 1270. Therefore, our
estimated burden includes the general review and update of written
procedures (an annual average of 24 hours), and the recording and
justifying of any deviations from the written procedures under Sec.
1270.31(a) and (b) (an annual average of 1 hour). The information
collection burden for maintaining records concurrently with the
performance of each significant screening and testing step and for
retaining records for 10 years under Sec.  1270.33(a), (f), and (h)
include documenting the results and interpretation of all required
infectious disease tests and results and the identity and relevant
medical records of the donor required under Sec.  1270.35(a) and (b).
Therefore, the burden under these provisions is calculated together in
table 1 of this document. The recordkeeping estimates for the number of
total annual records and hours per record are based on information
provided by industry and our experience with the information
collection.
    We estimate the burden of this information collection as follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
 21 CFR part 1270; human tissue      Number of      records per    Total annual         per         Total hours
  intended for  transplantation    recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
                                        Subpart C--Procedures and Records
----------------------------------------------------------------------------------------------------------------
1270.31(a), (b), (c), and (d)                 32               1              32              24             768
 \2\............................
1270.31(a) and 1270.31(b) \3\...              32               2              64               1              64
1270.33(a), (f), and (h), and                 32        6,198.84         198,363             1.0         198,363
 1270.35(a) and (b).............
1270.35(c)......................              32       11,876.12         380,036             1.0         380,036
1270.35(d)......................              32        1,454.50          47,504             1.0          47,504
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         626,735
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Review and update of standard operating procedures (SOPs).
\3\ Documentation of deviations from SOPs.

    Based on a review of the information collection since our last OMB
approval, we have made no adjustments to our burden estimate.

    Dated: September 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20669 Filed 9-23-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 162 (Tuesday, August 21, 2012)]
[Notices]
[Pages 50495-50497]
[FR Doc No: 2012-20512]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2004-0500; FRL-9719-5]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Information Collection Activities Associated With
EPA's ENERGY STAR Program in the Residential Sector; EPA ICR No.
2193.03

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR is
scheduled to expire on February 28, 2013. Before submitting the ICR to
OMB for review and approval, EPA is soliciting comments on specific
aspects of the proposed information collection as described below.

DATES: Comments must be submitted on or before October 22, 2012.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2004-0500, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center, Air and Radiation Docket, Mailcode 28221T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460.
     Hand Delivery: Air and Radiation Docket in the EPA Docket
Center (EPA/DC), EPA West Building, Room 3334, 1301 Constitution Ave.
NW., Washington, DC. 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-OAR-
2004-0500. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
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 www.regulations.gov
or email. The 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 email comment directly to EPA without going through
www.regulations.gov, your email 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. For additional information about EPA's public docket, visit
the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Brian Ng, Energy Star Residential
Branch, Mailcode 6202J, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202)
343-9162; fax number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How can I access the docket and/or submit comments?

    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OAR-2004-0500, which is available for online viewing at
www.regulations.gov, or in person viewing at the Air and Radiation
Docket in the EPA Docket Center (EPA/DC), EPA West Building, Room 3334,
1301 Constitution Ave. NW., Washington, DC. The EPA/DC Public Reading
Room is open from 8 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Reading Room is 202-566-
1744, and the telephone number for the Air and Radiation Docket is 202-
566-1742.
    Use www.regulations.gov to obtain a copy of the draft collection of
information, submit or view public comments, access the index listing
of the contents of the docket, and to access those documents in the
public docket that are available electronically. Once in the system,
select ``search,'' then key in the docket ID number identified in this
document.

What information is EPA particularly interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    (i) Evaluate 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;
    (ii) Evaluate 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;
    (iii) Enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) Minimize the burden of the collection of information on those
who are to respond, including through 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 particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

What should I consider when I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

What information collection activity or ICR does this apply to?

    Affected entities: Entities potentially affected by this action are
home builders, modular and manufactured home plants, developers,
verification organizations, lenders, energy efficiency program sponsors
(e.g., national, regional, state, or local government entities,
utilities), architects, home plan designers, retailers, contractors,
and homeowners.
    Title: Information Collection Activities Associated with EPA's
ENERGY STAR Program in the Residential Sector.
    ICR numbers: EPA ICR No. 2193.03, OMB Control No. 2060-0586.
    ICR status: This ICR is currently scheduled to expire on February
28, 2013. 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 numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9 and are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: Improving energy efficiency is one of the easiest,
fastest, and most cost-effective solutions for reducing greenhouse gas
(GHG) emissions, which contribute to climate change. As one of our
nation's important environmental challenges, climate change demands
practical, proven solutions that can be implemented today to protect us
tomorrow. Under the EPA's leadership many American consumers,
businesses, and organizations have already taken action. Their
investments in energy efficiency are transforming the market for
efficient homes, products, buildings, and practices, creating jobs, and
stimulating the economy.
    The ENERGY STAR program has been instrumental in identifying cost-
effective, innovative solutions for reducing GHG emissions since it was
launched by EPA in 1992. This voluntary, market-based, public-private
partnership program has boosted the adoption of energy-efficient
products, homes, buildings, practices, and services through valuable
partnerships, objective measurement tools, and consumer education.
ENERGY STAR helps to dismantle barriers to widespread energy efficiency
by serving as a trusted source of unbiased information that helps
consumers and businesses make choices that are good for the environment
and the economy.
    Through 2011, nearly 20,000 organizations have partnered with EPA,
improved efficiency, and realized

significant financial and environmental benefits. Americans, with the
help of ENERGY STAR, prevented 210 million metric tons of GHG emissions
in 2011 alone--equivalent to the annual emissions from 41 million
vehicles--and reduced their utility bills by $23 billion.
    EPA first developed energy efficiency guidelines for new homes in
1995. ENERGY STAR's existing homes effort was rolled out in 2000 to
promote cost-effective upgrades in the existing homes market. Both of
these efforts promote cost effective, whole house energy efficiency
improvements that are independently verified by third parties. Through
2011 there have been more than 1.3 million ENERGY STAR certified new
homes built in the U.S., and more than 50,000 existing homes have been
improved through the whole house retrofit program, Home Performance
with ENERGY STAR.
    Since participation in the ENERGY STAR program is voluntary,
organizations are not required to submit information to EPA.
Information received to date has been submitted voluntarily to EPA and
is not of a confidential nature. EPA has developed this ICR to obtain
authorization to collect information from the public, including
businesses, for the following activities:
    ENERGY STAR Partnership and Related Activities: An organization
interested in joining ENERGY STAR as a partner is asked to submit a
partnership agreement establishing its commitment to ENERGY STAR.
Partners agree to undertake efforts such as educating their staff and
the public about their partnership with ENERGY STAR, developing and
implementing a plan to improve energy performance in homes, and
highlighting achievements utilizing the ENERGY STAR brand.
    Evaluation: Partners and other program participants are asked to
periodically submit information to EPA as needed to assist in
evaluating ENERGY STAR's effectiveness in helping organizations promote
energy efficiency in homes, to assess partners' level of interest and
ability in promoting ENERGY STAR in the residential sector, and to
determine the impact that ENERGY STAR has on residential energy use and
the supply and demand for energy-efficient homes and home improvement
products and services.
    Periodic Reporting: Partners are asked to submit information to EPA
periodically to assist EPA in tracking and measuring progress in
building and promoting ENERGY STAR certified homes and installing and
promoting energy-efficient improvements. This includes submitting
quarterly updates on partners' level of activity in certifying new
homes for the ENERGY STAR label and activity in improving the energy
efficiency of existing homes under Home Performance with ENERGY STAR
and ENERGY STAR's HVAC Quality Installation program.
    ENERGY STAR Awards: Each year, partners are eligible for an ENERGY
STAR award, which recognizes organizations demonstrating outstanding
support in promoting ENERGY STAR. This award program provides partners
public recognition and market differentiation. An application form is
submitted to EPA by partners interested in being eligible for an award.
    Burden Statement: The annual burden for joining ENERGY STAR and
conducting related activities is estimated to range from about 1 to 40
hours per respondent. This includes time for preparing and submitting
the Partnership Agreement and related information, if requested.
However, the majority of this time is for verification organization
partners to verify that site-built, modular, and manufactured homes
meet specified energy efficiency standards. The annual burden for
partner evaluations is estimated to be about 15 minutes per respondent.
This includes time for responding to EPA's questions posed during a
phone interview or other method. The annual burden for quarterly
reporting is estimated to be about 75 hours per respondent. This
includes time for submitting specified information to EPA on a
quarterly basis. The annual burden for the annual awards is estimated
to be about 13 hours per respondent. This includes time for preparing
and submitting the application materials and, if requested, an annual
report.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
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; adjust the existing ways to
comply with any previously applicable instructions and requirements
which 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.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 56,000.
    Frequency of response: Once, quarterly, annually, and occasionally.
    Estimated total annual burden hours: 180,958.
    Estimated total annual costs: $10.9 million. This includes an
estimated cost of approximately $10.9 million for labor and $17,000 for
capital investment, operation and maintenance.

Are there changes in the estimates from the last approval?

    The burden estimates presented in this notice are from the last
approval. EPA is currently evaluating and updating these estimates as
part of the ICR renewal process. EPA will discuss its updated
estimates, as well as changes from the last approval, in the next
Federal Register notice to be issued for this renewal.

What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: August 13, 2012.
Elizabeth Craig,
Director, Climate Protection Partnerships Division.
[FR Doc. 2012-20512 Filed 8-20-12; 8:45 am]
BILLING CODE 6560-50-P