[Federal Register Volume 86, Number 138 (Thursday, July 22, 2021)]
[Notices]
[Pages 38703-38704]
[FR Doc No: 2021-15541]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2310-243]

Pacific Gas and Electric Company; Notice of Application Accepted
for Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Temporary variance of license requirement.
    b. Project No.: 2310-243.
    c. Date Filed: July 8, 2021 and supplemented on July 14, 2021.
    d. Applicant: Pacific Gas and Electric Company (licensee).
    e. Name of Project: Drum-Spaulding Project.
    f. Location: South Yuba River and Bear River in Placer and Nevada
counties, California.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Michelle Ocken, License Coordinator, Pacific
Gas and Electric Company,<PHONE_NUMBER>.
    i. FERC Contact: Robert Ballantine,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and protests
is 20 days from the issuance of this notice by the Commission (August
4, 2021).
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, MD 20852. The first page of any filing should
include docket number P-2310-243. Comments emailed to Commission staff
are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: Due to persistent drought conditions,
the licensee requests Commission approval of a temporary variance of
the minimum flow requirement at streamflow gage YB-292 (Mormon Ravine).
The licensee is requesting to decrease the target flow from an
instantaneous 5 cubic feet per second (cfs) to 3 cfs, measured as a 24-
hour average. The reduced flow is necessary to manage water resources
in association with Placer County Water Agency and license required
flows. If granted, the variance would last through October 1, 2021, or
until adequate precipitation occurs to ensure that inflow equals
outflow at the referenced reservoir for at least seven consecutive
days, whichever comes later.
    l. Locations of the Application: 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 website at
http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number
excluding the last three digits in the docket number field to access
the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and
issuances related to this or other pending projects. Agencies may
obtain copies of the application directly from the applicant. 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,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: All filings must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. A copy of all other filings in reference to this
application must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 385.2010.

    Dated: July 15, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-15541 Filed 7-21-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Pages 57154-57156]
[FR Doc No: 2021-22308]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6841]

Select Updates for Unique Device Identification: Policy Regarding
Global Unique Device Identification Database Requirements for Certain
Devices; Draft Guidance for Industry and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of the draft guidance entitled ``Select
Updates for Unique Device Identification: Policy Regarding Global
Unique Device Identification Database Requirements for Certain Devices;
Draft Guidance for Industry and Food and Drug Administration Staff.''
This draft guidance explains that there are certain class I devices for
which FDA does not intend to enforce Global Unique Device
Identification Database (GUDID) submission requirements and describes
how a labeler of a class I device can determine if its device is one of
these devices in the revised section III of this draft guidance. When
this draft guidance is finalized, the updates in section III of this
draft guidance would supersede the recommendations in section III of
the guidance ``Unique Device Identification: Policy Regarding
Compliance Dates for Class I and Unclassified Devices and Certain
Devices Requiring Direct Marking''

(``2020 UDI Compliance Policy Guidance,'' available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identification-policy-regarding-compliance-dates-class-i-and-unclassified-devices-and). This draft guidance is not final nor is
it in effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by December 13, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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 Docket No.
FDA-2017-D-6841 for ``Select Updates for Unique Device Identification:
Policy Regarding Global Unique Device Identification Database
Requirements for Certain Devices; Draft Guidance for Industry and Food
and Drug Administration Staff.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Select Updates for Unique Device Identification: Policy Regarding
Global Unique Device Identification Database Requirements for Certain
Devices; Draft Guidance for Industry and Food and Drug Administration
Staff'' to the Office of Policy, Guidance and Policy Development,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002; or the Center for Biologics Evaluation and
Research, Office of Communication, Outreach and Development, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993. Send one
self-addressed adhesive label to assist that office in processing your
request.

FOR FURTHER INFORMATION CONTACT: Steven Luxenberg, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 3216, Silver Spring, MD 20993-0002, 301-
796-5995; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled ``Select
Updates for Unique Device Identification: Policy Regarding Global
Unique Device Identification Database Requirements for Certain Devices;
Draft Guidance for Industry and Food and Drug Administration Staff.''
On September 24, 2013 (78 FR 58786), FDA published a final rule
establishing a unique device identification system designed to
adequately identify devices through distribution and use (the UDI
Rule). Phased implementation of the regulatory requirements set forth
in that final rule is based on a series of established compliance dates
based primarily on device classification.
    The UDI Rule requires a device to bear a UDI on its label and
packages, unless an exception or alternative applies (see 21 CFR
801.20), and special labeling requirements apply to stand-alone
software regulated as a device (21 CFR 801.50). The UDI Rule also
requires that data pertaining to the key characteristics of each device
required to bear a UDI be submitted to FDA's GUDID (Sec.  830.300 (21
CFR 830.300)). In addition, the UDI Rule added 21 CFR 801.18, which
requires certain dates on device labels to be in a standard format.

For devices that: (1) Must bear UDIs on their labels and (2) are
intended to be used more than once and reprocessed between uses, 21 CFR
801.45 requires the devices to be directly marked with a UDI.
Compliance dates for these labeling, GUDID data submission, standard
date format, and direct marking requirements can be found in the
preamble to the UDI Rule (78 FR 58786 at 58815 to 58816). For more
information about UDI compliance dates, please see the UDI web page,
available at: https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/compliance-dates-udi-requirements.
    For labelers of class I devices, FDA has developed this draft
guidance to revise section III. ``Policy On Standard Date Formatting,
UDI Labeling, and GUDID Submission Requirements for Class I and
Unclassified Devices'' of the guidance entitled ``Unique Device
Identification: Policy Regarding Compliance Dates for Class I and
Unclassified Devices and Certain Devices Requiring Direct Marking''
(``2020 UDI Compliance Policy Guidance'', available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identification-policy-regarding-compliance-dates-class-i-and-unclassified-devices-and), which was issued on July 1, 2020. When
this draft guidance is finalized, the updates in section III of this
draft guidance would supersede the recommendations in section III of
the 2020 UDI Compliance Policy Guidance. FDA considered comments
received on the guidance that appeared in the Federal Register on July
1, 2020 (85 FR 39477) as the Agency revised the guidance.
    This draft guidance explains that there are certain class I devices
for which FDA does not intend to enforce GUDID submission requirements
under Sec.  830.300 and describes how a labeler of a class I device can
determine if its device is considered a consumer health product. FDA
has determined that the entry of UDI data into GUDID for these devices
is burdensome to stakeholders. After undertaking a public health impact
analysis, the Center for Devices and Radiological Health has a better
understanding of the devices and device characteristics for which GUDID
information is particularly useful in evaluating and improving device
safety throughout a product life cycle, as well as the ones for which
GUDID information may be less important in this regard. The policy
proposed in this draft guidance is based on this analysis. We are
proposing this change in policy through guidance to allow FDA and
stakeholders an opportunity to fully assess its impact on public
health. FDA will take the assessment into account in determining
whether regulations on this subject should be amended in the future.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Select
Updates for Unique Device Identification: Policy Regarding Global
Unique Device Identification Database Requirements for Certain Devices;
Draft Guidance for Industry and Food and Drug Administration Staff''.
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations have been approved by
OMB as listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
            21 CFR part                     Topic               No.
------------------------------------------------------------------------
801 subpart B and 830.............  Unique Device              0910-0720
                                     Identification.
800, 801, and 809.................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
------------------------------------------------------------------------

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of
``Select Updates for Unique Device Identification: Policy Regarding
Global Unique Device Identification Database Requirements for Certain
Devices; Draft Guidance for Industry and Food and Drug Administration
Staff'' may send an email request to [email protected] to
receive an electronic copy of the document. Please use the document
number 17029 and complete title to identify the guidance you are
requesting.

    Dated: October 7, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22308 Filed 10-13-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Notices]
[Pages 42001-42002]
[FR Doc No: 2020-15009]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2836]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Donor Risk Assessment
Questionnaire for the Food and Drug Administration/National Heart,
Lung, and Blood Institute-Sponsored Transfusion-Transmissible
Infections Monitoring System--Risk Factor Elicitation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Submit written comments (including recommendations) on the
collection of information by August 12, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0841. Also include the FDA docket
number found in brackets in the heading of this document.

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

Donor Risk Assessment Questionnaire for FDA/National Heart, Lung, and
Blood Institute (NHLBI)-Sponsored Transfusion-Transmissible Infections
Monitoring System (TTIMS)--Risk Factor Elicitation (RFE)

OMB Control Number 0910-0841--Revision

    FDA intends to interview blood donors to collect risk factor
information associated with testing positive for a TTI. This collection
of information is part of a larger initiative called TTIMS, which is a
collaborative project funded by FDA, the NHLBI of the National
Institutes of Health (NIH), and the Department of Health and Human
Services (HHS) Office of the Assistant Secretary of Health with input
from other Agencies in HHS, including the Centers for Disease Control
and Prevention (CDC). FDA will use these scientific data collected
through such interview-based risk factor elicitation of blood donors to
monitor and help ensure the safety of the U.S. blood supply.
    Previous assessments of risk factor profiles among blood donors
found to be positive for human immunodeficiency virus (HIV) were funded
by CDC for approximately 10 years after implementation of HIV serologic
screening of blood donors in the mid-1980s, whereas studies of
Hepatitis C virus (HCV) seropositive donors, funded by NIH, were
conducted in the early 1990s. Information on current risk factors in
blood donors as assessed using analytical study designs was next
evaluated by the Transfusion-Transmitted Retrovirus and Hepatitis Virus
Rates and Risk Factors Study conducted by the NHLBI Retrovirus
Epidemiology Donor Study-II (REDS-II) approved under OMB control number
0925-0630. Through a risk factor questionnaire, this study elicited
risk factors in blood donors who tested confirmed positive for one of
four transfusion-transmissible infections: HIV, HCV, Hepatitis B virus
(HBV), and Human T-cell Lymphotropic virus. The study also elicited
risk factors from donors who did not have any infections (controls) and
compared their responses to those of the donors with confirmed
infection (cases). Results from the REDS-II study were published in
2015.
    FDA recently revised the currently approved collection instrument
for the collection of information and have included recently issued
Agency guidance. On April 2, 2020, FDA issued a revised guidance
document entitled ``Revised Recommendations for Reducing the Risk of
Human Immunodeficiency Virus Transmission by Blood and Blood Products;
Guidance for Industry'' dated April 2020 (available at: https://www.fda.gov/media/92490/download), which changed the blood donor
criterion for men who have sex with men (MSM) from a 12-month deferral
to a 3-month deferral since last MSM contact. The impact of this change
in the deferral criteria requires a national monitoring effort as part
of TTIMS to assess if the relative proportions of risk factors for
infection in blood donors have changed following the adoption of the 3-
month donor deferral for MSM. We also made a change to the Risk Factor
Assessment interview questionnaire to keep the TTIMS interview relevant
with the current deferral. TTIMS will use similar procedures as the
ones used in the REDS-II study to monitor and evaluate risk factors
among HIV-positive donors and recently HCV or HBV infected donors as
well as controls.
    This study will help identify the specific risk factors for TTI and
their prevalence in blood donors and help inform FDA on the proportion
of incident (new) infections among all HIV positive blood donors.
Donations with incident infections have the greatest potential
transmission risk because they could be missed during routine blood
screening. The study will help FDA evaluate the effectiveness of
screening strategies in reducing the risk of HIV transmission from at-
risk donors and to evaluate if there are unexpected consequences
associated with the recent change in donor deferral policy such as an
increase in HIV incidence among donors. These data also will inform FDA
regarding future blood donor deferral policy options to reduce the risk
of HIV transmission, including the feasibility of moving from the
existing time-based deferrals related to risk behaviors to alternate
deferral options, such as the use of individual risk assessments, and
to inform the design of potential studies to evaluate the feasibility
and effectiveness of such alternative deferral options.
    TTIMS will include a comprehensive interview-based epidemiological
study of risk factor information for viral infection-positive blood
donors at the American Red Cross (ARC), Blood Systems, Inc. (BSI), New
York Blood Center (NYBC), and OneBlood that will identify the current
predominant risk factors and reasons for virus-positive donations. The
TTIMS program establishes a new, ongoing donor hemovigilance capacity
that currently does not exist in the United States. Using procedures
developed by the REDS-II study, TTIMS will establish this capacity in
greater than 50 percent

of all blood donations collected in the country.
    As part of the TTIMS project, a comprehensive hemovigilance
database will be created that integrates the risk factor information
collected through interviews of blood donors with the resulting data
from disease marker testing and blood components collected by
participating organizations into a research database. Following
successful initiation of the risk factor interviews, the TTIMS network
is poised to be expanded to include additional blood centers and/or
refocused on other safety threats as warranted. In this way, the TTIMS
program will maintain standardized, statistically, and scientifically
robust processes for applying hemovigilance information across blood
collection organizations.
    The specific objectives are to:
     Determine current behavioral risk factors associated with
all HIV infections, incident HBV, and incident HCV infections in blood
donors (including parenteral and sexual risks) across the participating
blood collection organizations using a case-control study design.
     Determine infectious disease marker prevalence and
incidence for HIV, HBV, and HCV overall and by demographic
characteristics of donors in the majority of blood donations collected
in the country. This will be accomplished by forming epidemiological
databases consisting of harmonized operational data from ARC, BSI,
NYBC, and OneBlood.
     Analyze integrated risk factor and infectious marker
testing data concurrently because when taken together these may suggest
that blood centers are not achieving the same degree of success in
educational efforts to prevent donation by donors with risk behaviors
across all demographic groups.
    The respondents will be persons who donated blood in the United
States and these participants will be defined as cases and controls.
The estimated number of respondents is based on an overall expected
participation in the risk factor survey. We estimate a case-to-control
ratio of 1:2 (200 to 400) with a 50 percent case enrollment.
    In the Federal Register of January 8, 2020 (85 FR 922), we
published a 60-day notice requesting public comment on the proposed
collection of information. We received two comments that were generally
supportive of the collection. One comment also contained a specific
suggestion that, in analyzing the data after it is collected, we
utilize an ``underreporting correction factor'' identified by the
commenter. The comment did not suggest that we make any changes to the
Donor Risk Assessment Questionnaire or the information collection
requirements. We appreciate the commenter's interest in the accuracy of
the TTIMS and will consider the ``underreporting correction factor''
identified by the commenter when analyzing the data.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
     Questionnaire/survey          Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Cases and controls \2\........             600               1             600  0.5 (30 minutes)             300
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Cases consist of virus-positive donations and controls represent uninfected donors.

    We have adjusted our burden estimate, which has resulted in a
decrease to the currently approved burden. Based on experience with
this survey, we decreased the average burden per response from 45 to 30
minutes, resulting in a change from 450 to 300 total hours.

    Dated: July 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15009 Filed 7-10-20; 8:45 am]
BILLING CODE 4164-01-P


  SEQ CHAPTER \h \r 1

Information Collection Request:

Questionnaire for Nominees for the Annual National Clean Water Act
Recognition Awards

EPA ICR # 1287.09

OMB Control No. 2040-0101

September 2007

Prepared for

U.S. Environmental Protection Agency

Office of Wastewater Management

1200 Pennsylvania Avenue, N.W.

Washington, DC 20460

Prepared by

Tetra Tech, Inc.

10306 Eaton Place, Suite 340

Fairfax, VA 22030

EPA Contract Number EP-C-05-046

EPA Work Assignment Number 1-43

CONTENTS

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc176681796"  Section 1:
Identification of the Information Collection	  PAGEREF _Toc176681796 \h
1

  HYPERLINK \l "_Toc176681797"  1(a) Title of the Information Collection
  PAGEREF _Toc176681797 \h  1

  HYPERLINK \l "_Toc176681798"  1(b) Short Characterization/Abstract
PAGEREF _Toc176681798 \h  1

  HYPERLINK \l "_Toc176681799"  Section 2: Need for and Use of the
Collection	  PAGEREF _Toc176681799 \h  2

  HYPERLINK \l "_Toc176681800"  2(a) Need/Authority for the Collection
PAGEREF _Toc176681800 \h  2

  HYPERLINK \l "_Toc176681801"  2(b) Practical Utility/Users of the Data
  PAGEREF _Toc176681801 \h  2

  HYPERLINK \l "_Toc176681802"  Section 3: Non-duplication,
Consultations, and Other Collection Criteria	  PAGEREF _Toc176681802 \h
2

  HYPERLINK \l "_Toc176681803"  3(a) Non-duplication	  PAGEREF
_Toc176681803 \h  2

  HYPERLINK \l "_Toc176681804"  3(b) Public Notice Required Prior to ICR
Submission to OMB	  PAGEREF _Toc176681804 \h  2

  HYPERLINK \l "_Toc176681805"  3(c) Consultations	  PAGEREF
_Toc176681805 \h  2

  HYPERLINK \l "_Toc176681806"  3(d) Effects of Less Frequent Collection
  PAGEREF _Toc176681806 \h  3

  HYPERLINK \l "_Toc176681807"  3(e) General Guidelines	  PAGEREF
_Toc176681807 \h  3

  HYPERLINK \l "_Toc176681808"  3(f) Confidentiality	  PAGEREF
_Toc176681808 \h  3

  HYPERLINK \l "_Toc176681809"  3(g) Sensitive Questions	  PAGEREF
_Toc176681809 \h  3

  HYPERLINK \l "_Toc176681810"  Section 4: The Respondents and the
Information Requested	  PAGEREF _Toc176681810 \h  3

  HYPERLINK \l "_Toc176681811"  4(a) Respondents/SIC and NAICS Codes
PAGEREF _Toc176681811 \h  3

  HYPERLINK \l "_Toc176681812"  4(b) Information Requested	  PAGEREF
_Toc176681812 \h  4

  HYPERLINK \l "_Toc176681813"  i) Data items, including record keeping
requirements	  PAGEREF _Toc176681813 \h  4

  HYPERLINK \l "_Toc176681814"  ii) Respondent Activities	  PAGEREF
_Toc176681814 \h  4

  HYPERLINK \l "_Toc176681815"  Section 5: The Information
Collected-Agency Activities, Collection Methodology, and Information
Management	  PAGEREF _Toc176681815 \h  4

  HYPERLINK \l "_Toc176681816"  5(a) Agency Activities	  PAGEREF
_Toc176681816 \h  4

  HYPERLINK \l "_Toc176681817"  5(b) Collection Methodology and
Management	  PAGEREF _Toc176681817 \h  4

  HYPERLINK \l "_Toc176681818"  5(c) Small Entity Flexibility	  PAGEREF
_Toc176681818 \h  5

  HYPERLINK \l "_Toc176681819"  5(d) Collection Schedule	  PAGEREF
_Toc176681819 \h  5

  HYPERLINK \l "_Toc176681820"  Section 6: Estimating the Burden and
Cost of the Collection	  PAGEREF _Toc176681820 \h  5

  HYPERLINK \l "_Toc176681821"  6(a) Estimating Applicants Respondents
Burden and Cost	  PAGEREF _Toc176681821 \h  5

  HYPERLINK \l "_Toc176681822"  6(b) Estimating State Respondents Burden
and Cost	  PAGEREF _Toc176681822 \h  6

  HYPERLINK \l "_Toc176681823"  6(c) Estimating Agency Burden and Cost
PAGEREF _Toc176681823 \h  6

  HYPERLINK \l "_Toc176681824"  6(d) Estimating the Respondents Universe
and Total Burden and Cost	  PAGEREF _Toc176681824 \h  7

  HYPERLINK \l "_Toc176681825"  6(e) Bottom Line Burden Hours and Cost
Estimates	  PAGEREF _Toc176681825 \h  7

  HYPERLINK \l "_Toc176681826"  6(f) Reasons for change in burden
PAGEREF _Toc176681826 \h  8

  HYPERLINK \l "_Toc176681827"  6(g) Burden Statement	  PAGEREF
_Toc176681827 \h  8

 Appendices

Tables

  TOC \h \z \t "Table Title,1"    HYPERLINK \l "_Toc159913337"  Table 1.
Collection Burden for 200 Respondents	  PAGEREF _Toc159913337 \h  6

  HYPERLINK \l "_Toc159913338"  Table 2. Estimated Review Burden of
States per Response	  PAGEREF _Toc159913338 \h  6

  HYPERLINK \l "_Toc159913339"  Table 3. Summary of Federal Salaries
PAGEREF _Toc159913339 \h  6

  HYPERLINK \l "_Toc159913340"  Table 4. Summary of Federal Travel to
National Awards Conference	  PAGEREF _Toc159913340 \h  7

  HYPERLINK \l "_Toc159913341"  Table 5. Federal Recognition Awards Cost
Summary	  PAGEREF _Toc159913341 \h  7

  HYPERLINK \l "_Toc159913342"  Table 6. Aggregate Burden for
Respondents and States Activities	  PAGEREF _Toc159913342 \h  7

 Section 1: Identification of the Information Collection

1(a) Title of the Information Collection

Questionnaire for Nominees for the Annual National Clean Water Act
Recognition Awards. EPA ICR No. 1287.09, OMB Control No. 2040-0101

1(b) Short Characterization/Abstract

This questionnaire is developed to collect information for the
Environmental Protection Agency's (EPA) National Clean Water Act
Recognition Awards Program, formerly the National Wastewater Management
Excellence Awards Program.

In 1985, EPA established the Operations and Maintenance (O&M) awards
program to provide a positive incentive for compliance with the National
Pollutant Discharge Elimination System (NPDES). Because of the successes
of the O&M Awards program, in 1988, EPA established the Beneficial
Biosolids Use awards (formerly Sludge awards). In 1989, the Pretreatment
awards were added. In 1990, EPA established the Combined Sewer Overflow
(CSO) and Storm Water (SW) Management awards programs. The questionnaire
provides the mechanism for the applicant to demonstrate outstanding and
innovative wastewater management practices. The Pretreatment awards
program is covered by ICR (OMB Control No. 2040-0009, EPA ICR No.
0002.12), approved through September 30, 2007. A framework to implement
the awards recognition program is at 40 CFR part 105. A copy is attached
in Appendix A.

The respondent will read the instructions for completing the
questionnaire. The respondent will use existing files, planning and
progress reports, and institutional memory to complete the
questionnaire. Based on the instructions provided with the
questionnaire, the respondent will compile the requested information.
The requested design and operating information should be readily
available from wastewater treatment facility or pollution abatement
program operating records. The data collection will include flow,
permit, operating and environmental data.

The information collection will be used by the respective awards program
in the Office of Water, Office of Wastewater Management to evaluate and
determine which pollution abatement achievements should be recognized.
Based on the collection, national panels will evaluate the nominee's
efforts and recommend finalists. As currently structured, the O&M awards
program has nine sub-categories to recognize municipal achievements
based on plant flows and treatment level. The Biosolids awards program
has four sub-categories which recognize municipal biosolids operations,
technology and research achievements, and public acceptance. The CSO
awards program has one sub-category which recognizes municipal programs,
and the SW awards program has two sub-categories which recognize
municipal and industrial programs. Regions and States may also have
recognition awards programs and are included in these estimates.
National second place category winners may also be recognized.
Additionally, nominated activities may sometimes receive an honorable
mention or special award. The national Clean Water Act Recognition
Awards are presented annually at an EPA ceremony.

Total estimated burden for this collection is 2,030 hours and $85,738.
The cost to the Federal government is $139,983 per year.

Section 2: Need for and Use of the Collection

2(a) Need/Authority for the Collection

Section 501(e) of the CWA, as amended (copy attached in Appendix B)
authorizes a program to recognize municipalities and industries that
demonstrate outstanding technological achievements, innovative
processes, devices or other outstanding methods in their waste treatment
and pollution abatement programs. Recognition is made through EPA's
National Clean Water Act awards program. The program also heightens
public awareness of the contributions wastewater treatment facilities
and programs make to clean water, and encourages public support for
effective operations and maintenance. The design, operating, and
environmental compliance information of the wastewater treatment
facility or pollution abatement programs is needed to complete the
questionnaire.

2(b) Practical Utility/Users of the Data

Information collected will be used for the National Clean Water Act
Recognition Awards by EPA’s Office of Water, Office of Wastewater
Management.

Section 3: Non-duplication, Consultations, and Other Collection Criteria

3(a) Non-duplication

The design, operating, and environmental compliance information needed
to complete the questionnaire is not immediately available in the
database or files of a State or Federal office. If such data is
available, it may exist in an outdated report or database which cannot
be timely or readily cross-referenced to the requested data. Outstanding
and innovative program accomplishments must be provided from the
wastewater management facilities and programs as it is not available
from any other source.

3(b) Public Notice Required Prior to ICR Submission to OMB

In compliance with the 1995 Paperwork Reduction Act (PRA), any agency
developing a non-rule-related ICR must solicit public comments before
submitting the ICR to OMB.  These comments, which are used partly to
determine realistic burden estimates for respondents, must be considered
when completing the Supporting Statement that is submitted to OMB.

This ICR was published in the Federal Register on July 3, 2007 (72 FR
36449).  The notice included a request for comments on the content and
impact of these information collection requirements on the regulated
community.  EPA received one comment on this ICR.  EPA’s response to
the comment is addressed by this ICR and summarized in Appendix D of
this supporting statement.

3(c) Consultations

The program is in its twenty-first year of making awards. EPA strives to
minimize the burden on all respondents, especially small
communities/businesses. Each year comments are provided by the award
recipients, selection panel, and State and Regional EPA personnel. EPA
asks the Regional and State personnel to assist the respondents where
necessary in completing the questionnaire. Regions also ensure that the
nominees' environmental compliance records are reviewed and approved
before they complete the questionnaire.

EPA managers solicit feedback on its questionnaire from non-Federal
panelists and from past municipal winners in a very informal manner. EPA
managers also receive indirect comments from Regional EPA employees, who
also are in contact with municipal and industrial entities and State
officials. Positive and negative feedback are both evaluated. Feedback
from the State’s facility operators is that the national application
form for awards is complex and is a significant burden for the plant
staff. In order to improve participation, some Regions use a short form
to get the facilities into the award process for local, State and
Regional competition. Once the facilities have been selected for
nomination to the national competition, they complete the questionnaire
to compete for the national award. The questionnaire is revised if the
burden on the respondent is determined to unnecessarily outweigh the
information being requested to evaluate achievement.

3(d) Effects of Less Frequent Collection

If the collection is conducted on a less frequent basis, the merits and
goals of the program would be seriously impacted. Recognition awards are
held annually. The information collection schedule is contained in the
respondent's questionnaire instructions. The questionnaire and
instructions for the awards program are distributed by mail, email and
are available through the internet by December/January of each year. The
completed questionnaire is received by Headquarters in May/June, and the
panel reviews the questionnaires in June/July.

3(e) General Guidelines

This information collection request is consistent with guidelines
contained in 5 CFR 1320.5(d)(2).

3(f) Confidentiality

No confidential information is involved for this collection activity.

3(g) Sensitive Questions

The questionnaire does not request any information that would be of a
sensitive nature.

Section 4: The Respondents and the Information Requested

4(a) Respondents/SIC and NAICS Codes

The Standard Industrial Classification (SIC) and North American Industry
Classification System (NAICS) codes for the respondents affected by this
information collection activity are as follows:

SIC: 4952; NAICS: 22132 - Sewerage Systems

SIC: 4953; NAICS: 56292,<PHONE_NUMBER>13, 562219 - Refuse Systems

SIC: 8221; NAICS: 61131 - Colleges, Universities, Professional Schools

SIC: 8711; NAICS: 54133 - Engineering Services

SIC: 8734; NAICS: 54138 - Testing Laboratories

SIC: 9511; NAICS: 92411 - Air and Water Resource and Solid Waste
Management

	(Administration of Environmental Quality)

4(b) Information Requested

i) Data items, including record keeping requirements

The requested design and operating information should be readily
available from facility operating records. The information collection
will include flow, permit, operating, and environmental compliance data.

ii) Respondent Activities

To be considered for National Clean Water Act Recognition Awards, the
respondent will voluntarily complete the questionnaire and provide
design, operating and environmental information about their facility or
program. The respondents will read the instructions for completing the
questionnaire. The respondent will use existing files when possible,
planning and progress reports, and institutional memory to complete the
questionnaire. A copy of the current questionnaires is attached in
Appendix C.

Section 5: The Information Collected-Agency Activities, Collection
Methodology, and Information Management

5(a) Agency Activities

The completed questionnaire is reviewed by State/Regional officials, as
appropriate, prior to forwarding them to Headquarters. Not all States
have awards programs. Participation for the Regional awards may vary
each year for each award program category. After the questionnaires are
received at Headquarters, they are provided to the respective review
panels consisting of representatives from EPA's Headquarters and
regions, state water pollution control agencies or affiliated
associations for consideration of a national award. The panels make
recommendations to EPA.  All nominees complete a series of compliance
screenings. National nominees are invited to an EPA awards ceremony for
presentation of an engraved plaque in recognition of their outstanding
and innovative technological achievements. First place winners also
receive plant flags.

EPA Headquarters releases the names of the municipalities and industries
to be recognized, and summaries of awards justifications may be
published in reports, news articles, journals, and Federal Register
Notices.

5(b) Collection Methodology and Management

The regions may send information electronically as much as possible to
transmit completed questionnaires and other information to Headquarters.
All nominees are screened for environmental compliance by the State and
EPA. Data quality information will be retrieved from the Agency's Permit
Compliance System (PCS)—in the process of being replaced by the
Integrated Compliance Information System (ICIS)—and other
environmental reports, and professional knowledge of the facility or
program.

5(c) Small Entity Flexibility

This information collection activity does not concern a rulemaking. A
framework to implement the awards recognition program is at 40 CFR, part
105. EPA strives to minimize the burden on all respondents, especially
small communities/businesses. EPA Regions and States ensure that
Regional personnel review the nominee's environmental compliance records
before the nominee is asked to complete the questionnaire. Depending on
the respective program, Regions and States may be available to assist
respondents to answer the questionnaire to compete for the national
award. The questionnaire is shortened or revised if the burden on the
respondent appears to unnecessarily outweigh the information requested.

5(d) Collection Schedule

The information collection schedule is contained in the respondents'
questionnaire. The respective awards program manager sends out the
questionnaire and instructions in December/January of each year. The
completed questionnaire is received by Headquarters in May/June, and the
panel reviews the questionnaire in June/July. Recognition awards are
held annually in October at an EPA awards ceremony.

Section 6: Estimating the Burden and Cost of the Collection

The total number of applicant respondents is estimated to be 145,
including 100 for the O&M program, 25 for the Biosolids program, 10 for
the CSO program, and 10 for the SW program. The responses are collected
once annually. The respondents reporting burden of 8 person hours per
response (2 hours for manager to read instructions and search data; 5
hours for staff to gather information and complete the questionnaire;
and 1 hour for administrative support staff to prepare forms—see Table
1) is estimated to be 1,160 hours and a cost of $49,721. The States'
review burden of 6 person hours per response (1 hour for management
review; 4 hours for staff to review and verify data and make nominations
for awards; and 1 hour for administrative support—see Table 2) is 870
hours and a cost of $36,017.  Although not all states are expected to
participate in the award programs, all are eligible to participate.
Total estimated burden for this collection is 2,030 hours and $85,738.
The cost to the Federal government is $139,983 per year. An explanation
follows:

6(a) Estimating Applicants Respondents Burden and Cost

Table 1 presents the burden and cost to applicants respondents. A labor
rate of $50.41 hour was used for managers, $44.10 for staff, and $21.58
for administrative support. These rates are based on the mean hourly
cost of employment for all occupations, including benefits.  These
hourly rates were based on the average hourly wage for civilian workers
as determined by the U.S. Department of Labor.

Table 1. Burden and Cost for Applicants Respondents

Activity	No. of Responses	No. Person Hours per response	Total Burden
Cost per Hour	Total Annual Labor Cost

Manager reads instructions and search existing data sources	145	2	290
$50.41	$14,619

Staff gathers information and complete the questionnaire	145	5	725
$44.10	$31,973

Administrative support prepares forms	145	1	145	$21.58	$3,129

TOTAL

8	1160	---	$49,721

6(b) Estimating State Respondents Burden and Cost

Table 2 presents the burden and cost to state respondents. A labor rate
of $50.41 hour was used for managers, $44.10 for staff, and $21.58 for
administrative support. These rates are based on the mean hourly cost of
employment for all occupations, including benefits.  These hourly rates
were based on the average hourly wage for civilian workers as determined
by the U.S. Department of Labor.

Table 2. Burden and Cost for State Respondents

Activity	No. of Responses	No. Person Hours per response	Total Burden
Cost per Hour	Total Annual Labor Cost

Management review	145	1	145	$50.41	$7,309

Staff review/verify data and make nominations for awards	145	4	580
$44.10	$25,578

Administrative Support	145	1	145	$21.58	$3,129

TOTAL

6	870

$36,017

6(c) Estimating Agency Burden and Cost

For tables 3 and 4, the hourly labor rates for the federal government
are based on the hourly rates by grade and step, from the US Office of
Personnel Management, assuming overhead costs of 50 percent.
(http://www.opm.gov/oca/07tables/html/gs_h.asp)

Table 3. Summary of Costs to EPA Headquarters

Activity 	Person Hours	Estimated Cost per Hour	Total Annual Cost

Branch Chiefs (Average hourly rate of GS-15, Step 10 plus 50% overhead
burden)	8	$86.96	$696

Awards Program Managers (Average hourly rate of GS-13, Step 5 plus 50%
overhead burden)	192	$54.56	$10,476

TOTAL	200	-	$11,171

Branch Chiefs: 2 person hours x 4 categories = 8 person hours.

Awards Program Managers: 48 person hours (6/ 8hr days) x 4 categories =
192 person hours

Table 4. Summary of Costs to EPA Regions

Activity 	Person Hours	Estimated Cost per Hour	Total Annual Cost

Awards Program Managers (Average hourly rate of GS-13, Step 5 plus 50%
overhead burden)	1,920	$54.56	$104,755

Administrative Support and Typing (Average hourly rate of GS-8, Step 5
plus 50% overhead burden	80	$28.64	$2,291

TOTAL	2,000	-	$107,046

Awards Program Managers: 48 person hours (6/ 8hr days) x 10 Regions x 4
categories = 1,920 person hours

Administrative Support and Typing: 2 person hours x 10 regions x 4
categories = 80 person hours.

Table 5. Summary of Federal Travel to National Awards Conference

Activity	No of Travelers	Estimated Cost per Travelera	Total Annual Cost

EPA Awards Presenters	2	$1,099 	$2,198

O&M Awards	1	$1,099 	$1,099

Biosolids Awards	1	$1,099 	$1,099

Storm Water Awards	1	$1,099 	$1,099

Combined Sewer Overflow Awards	1	$1,099 	$1,099

TOTAL

	$6,594

a. Costs from the previous ICR (EPA ICR No. 1287.07) updated to December
2006 dollars using Consumer Price Index data from the U.S. Department of
Labor, Bureau of Labor Statistics

Table 6. Federal Recognition Awards Cost Summary

Activity (Includes Pretreatment)	No. of Items 	Cost per Itema	Total
Annual Cost

Regional O&M Award Plaques (2 per region)	20	$49 	$980

National awards plaques 	42	$49 	$2,058

National awards certificates	42	$27 	$1,134

National first place awards flags	20	$550 	$11,000

TOTAL

	$15,172

a. Costs from the previous ICR (EPA ICR No. 1287.07) updated to December
2006 dollars using Consumer Price Index data from the U.S. Department of
Labor, Bureau of Labor Statistics

6(d) Estimating the Respondents Universe and Total Burden and Cost

The total number of respondents is estimated to be 145, including 100
for the O&M program, 25 for the Biosolids program, 10 for the CSO
program, and 10 for the SW program. The responses are collected once
annually. The respondents reporting burden of 8 person hours per
response is estimated to be 1,160 hours and a cost of $49,721. The
States' review burden of 6 person hours per response is 870 hours and a
cost of $36,017. Although not all states are expected to participate in
the award programs, all are eligible to participate. Total estimated
burden for this collection is 2,030 hours and $85,738.

6(e) Bottom Line Burden Hours and Cost Estimates

Table 7. Aggregate Burden for Respondents and States Activities

Entity	Respondents	Total Burden (Hours)

Applicants Respondents	145	1,160

States Respondents	50	870

Total Respondents	195	2,030

6(f) Reasons for change in burden

Information collection activity for the National Clean Water Act
Recognition Awards Program currently has OMB approval for 2,030 burden
hours for 145 respondents. The respondent's cost in the previous ICR was
estimated to be $66,265. We predict no change in the estimated burden
for the next three years. Cost will change to $85,738 due to changes in
labor rates and the effects of inflation.

6(g) Burden Statement

The public reporting burden for respondents is estimated to average 8
hours per response per year. For State respondents, the reporting burden
is estimated to average 6 hours per response per year. 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; 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. 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 are listed in 40 CFR Part 9 and 48 CFR
Chapter 15.

To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID No.
EPA-HQ-OW-2003-0064, which is available for public viewing at the Water
Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Ave., 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
(202) 566-1744, and the telephone number for the Water Docket is (202)
566-2426.  An electronic version of the public docket is available
through the Federal Docket Management System (FDMS) at
http://www.regulations.gov/.  Use FDMS to submit or view public
comments, access the index listing of the contents of the public docket,
and to access those documents in the public docket that are available
electronically.  Once in the system, key in the docket ID number
identified above.  Also, you can send comments to the Office of
Information and Regulatory Affairs, Office of Management and Budget, 725
17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA.
Please include the EPA Docket ID No. EPA-HQ-OW-2003-0064 and OMB control
number 2040-0101 in any correspondence.

 From U.S. Department of Labor, Bureau of Labor Statistics, Employer
Costs for Employee Compensation, Table 2, “Employer costs per hour
worked for employee compensation and costs as a percent of total
compensation: Civilian workers, by occupational and industry group,
December 2006.”: Management, business, and financial: $50.41,
Professional and related: $44.10, Office and administrative support:
$21.58. (http://stats.bls.gov/news.release/ecec.t02.htm)

 From U.S. Department of Labor, Bureau of Labor Statistics, Employer
Costs for Employee Compensation, Table 2, “Employer costs per hour
worked for employee compensation and costs as a percent of total
compensation: Civilian workers, by occupational and industry group,
December 2006.”: Management, business, and financial: $50.41,
Professional and related: $44.10, Office and administrative support:
$21.58. (http://stats.bls.gov/news.release/ecec.t02.htm)


[Federal Register: August 9, 2007 (Volume 72, Number 153)]
[Notices]
[Page 44843-44845]
[DOCID:fr09au07-63]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2003-0225; FRL-8452-4]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Populations, Usage and Emissions of Nonroad Diesel
Equipment in EPA Region 7; EPA ICR No. 2156.01, OMB Control No. 2060-
0553

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

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 November 30, 2007. 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 9, 2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2003-0225, by one of the following methods:
     http://www.regulations.gov: Follow the online instructions

for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Air and Radiation Docket and Information Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
     Hand Delivery: EPA Docket Center, Public Reading Room, EPA
West Building, Room 3334. 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-
2003-0225. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

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

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

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. 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: James Warila, Office of Transportation
and Air Quality, (ASD), Environmental Protection Agency, 2000
Traverwood Drive, Ann Arbor, MI 48105; telephone number:<PHONE_NUMBER>;
fax number:<PHONE_NUMBER>; e-mail 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-2003-0225, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Air and

Radiation Docket in the EPA Docket Center (EPA/DC), EPA West, 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<PHONE_NUMBER>.
    Use http://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

[Docket ID No. EPA-HQ-OAR-2003-0225]

    Affected entities: Entities potentially affected by this action are
construction establishments employing at least one person during the
previous twelve months (NAICS code 23).
    Title: Mobile-Source Emission Factors: Emissions and Usage of
Nonroad Equipment
    ICR numbers: EPA ICR No. 2156.01, OMB Control No. 2063-0553.
    ICR status: This ICR is currently scheduled to expire on November
30, 2007. 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, 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

    In response to recommendations from the National Research Council
of the National Academy of Sciences, EPA is conducting systematic data
collection designed to improve the methods and

tools used by the Agency to estimate emissions from nonroad equipment.
Data to be collected include usage rates (activity) and ``in-use'' or
``real-world'' emission rates.
    The collection is a survey, to be conducted by the Office of
Transportation and Air Quality (OTAQ) in the Office of Air and
Radiation (OAR). Development of rapid in-use instrumentation promises
to substantially reduce the cost of emissions measurement for nonroad
equipment. This study combines rapid in-use measurement capability with
statistical survey design to improve the representation of nonroad
engine populations. The goal is to conduct a survey designed to develop
methods and protocols needed to collect data on activity and in-use
emissions of diesel nonroad equipment. Response to the survey is
voluntary.
    The target population includes nonroad equipment used by commercial
establishments in the construction sector. The study area for this
collection will be EPA Region 7. To estimate the prevalence of
equipment ownership in the target sectors, establishments will be
requested to respond to brief interviews regarding their equipment
ownership and use. For a subset of establishments, emissions and usage
will be measured using portable on-board electronic instrumentation.
Emissions instrumentation will measure carbon dioxide (CO2)
and several air pollutants on an instantaneous basis during normal
operation over a period of one to three days. Air pollutants to be
measured include carbon monoxide (CO), total hydrocarbons (THC), oxides
of nitrogen (NOX) and particulate matter (PM). The usage
instrument will measure engine on/off over a period of approximately
one month. Data will be collected during normal operation at the
respondents' facilities or work sites.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 0.15
hours per response. 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 submitted for renewal will provide a detailed explanation
of the Agency's estimate, which is briefly summarized here:
    Estimated Total Number of Potential Respondents: 4,020.
    Frequency of Response: On occasion.
    Estimated Total Average Number of Responses for Each Respondent:
One.
    Estimated Total Annual Burden Hours: 580.
    Estimated Total Annual Costs: $52,000. This includes an estimated
burden cost of $52,000 and an estimated cost of $0.0 for capital
investment or maintenance and operational costs.

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 2, 2007.
Chester J. France,
Director, Assessment and Standards Division.
 [FR Doc. E7-15601 Filed 8-8-07; 8:45 am]

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