[Federal Register Volume 83, Number 214 (Monday, November 5, 2018)]
[Notices]
[Pages 55362-55363]
[FR Doc No: 2018-24159]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2018-0663; FRL-9986-11-OAR]

Proposed Information Collection Request; Comment Request;
Recordkeeping and Reporting Requirements for the Performance-Based
Measurement System for Fuels (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``Recordkeeping and
Reporting Requirements for the Performance-based Measurement System for
Fuels'' (EPA ICR No. 2459.03, OMB Control No. 2060-0692) to the Office
of Management and Budget (OMB) for review and approval in accordance
with the Paperwork Reduction Act. Before doing so, EPA is soliciting
public comments on specific aspects of the proposed information
collection as described below. This is a proposed extension of the ICR,
which is currently approved through May 31, 2019. An Agency may not
conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.

DATES: Comments must be submitted on or before January 4, 2019.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2018-0663, online using www.regulations.gov (our preferred method), by
email to [email protected], or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: James W. Caldwell, Compliance
Division, Office of Transportation and Air Quality, 6405A,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
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. 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. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: EPA regulations at 40 CFR part 80 set standards for
certain parameters of gasoline and diesel fuel, such as sulfur content,
to control harmful vehicle emissions and protect emission controls.
Refiners and importers are required to test for these parameters and
report the results to EPA. The regulations at 40 CFR part 80.47,
80.584, and 80.585 (1) identify acceptable test methods for some of the
regulated parameters, (2) specify criteria for precision, accuracy, and
quality control for the test methods used to measure the regulated
parameters (certain test methods in use prior to October 28, 2013 are
exempt from some of the criteria), and (3) establish procedures by
which a test laboratory can demonstrate that an alternative test method
meets the criteria and is thus ``qualified'' for use. This program for
the qualification of test methods is known as the Performance-based
Measurement

System (PBMS). Test laboratories are required to generate certain
records to demonstrate compliance with PBMS program requirements. This
ICR covers the recordkeeping and reporting requirements for PBMS
records. There are no required forms. Example formats for certain
records are at: https://www.epa.gov/fuels-registration-reporting-and-compliance-help/compliance-performance-based-measurement-system.
    Form numbers: None.
    Respondents/affected entities: Laboratories that test gasoline and
diesel fuel.
    Respondent's obligation to respond: Mandatory.
    Estimated number of respondents: 1,000 (total).
    Frequency of response: On occasion, periodically (varies with test
method).
    Total estimated burden: 26,696 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $2,460,454 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in estimates: There is an increase of 17,198 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This increase is due to an incorrect estimate of 52
laboratories for the current approval while the actual number should
have been near 1,000.

    Dated: October 29, 2018.
Byron J. Bunker,
Director, Compliance Division, Office of Transportation and Air
Quality, Office of Air and Radiation.
[FR Doc. 2018-24159 Filed 11-2-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 195 (Wednesday, October 13, 2021)]
[Notices]
[Pages 56960-56963]
[FR Doc No: 2021-22108]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1106]

Alcohol-Based Hand Sanitizer Products; Withdrawal of Three
Temporary Guidance Documents Issued During the Public Health Emergency
of the Coronavirus Disease 2019

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the withdrawal of three guidance documents entitled

``Temporary Policy for Preparation of Certain Alcohol-Based Hand
Sanitizer Products During the Public Health Emergency (COVID-19),''
``Policy for Temporary Compounding of Certain Alcohol-Based Hand
Sanitizer Products During the Public Health Emergency,'' and
``Temporary Policy for Manufacture of Alcohol for Incorporation Into
Alcohol-Based Hand Sanitizer Products During the Public Health
Emergency (COVID-19),'' which were issued in March 2020 (and updated
March 27, 2020, April 15, 2020, June 1, 2020, August 7, 2020, and
February 10, 2021). FDA is withdrawing these three guidance documents
because current data indicate that consumers and healthcare personnel
are no longer experiencing difficulties accessing alcohol-based hand
sanitizer products, and these temporary policies are no longer needed
to help meet demand for alcohol-based hand sanitizer products or for
alcohol for use in alcohol-based hand sanitizer.

DATES: The withdrawal date for the three guidances is December 31,
2021. Firms manufacturing alcohol under the temporary policies for use
in alcohol-based hand sanitizers and firms preparing alcohol-based hand
sanitizers under the temporary policies must cease production of these
products by December 31, 2021. Firms must cease, by March 31, 2022,
distribution of any remaining hand sanitizer products that were
prepared under the temporary policies before or on December 31, 2021.
After March 31, 2022, FDA intends to cease its temporary policy of not
taking action with regard to distribution of hand sanitizers, or
alcohol for use in alcohol-based hand sanitizers, prepared consistent
with the circumstances described in the guidance documents.

FOR FURTHER INFORMATION CONTACT: Kimberly Thomas, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    As part of FDA's commitment to providing timely guidance to support
continuity and response efforts to the Coronavirus Disease 2019 (COVID-
19) \1\ pandemic, in March 2020, the Agency published three guidance
documents to provide regulatory flexibility to certain firms to help
meet the demand for alcohol-based hand sanitizer during the COVID-19
public health emergency (PHE).\2\ The guidance documents communicate
the Agency's temporary policies on the manufacture of alcohol for use
in alcohol-based hand sanitizers, or alcohol-based hand sanitizers for
consumer use and for use as healthcare personnel hand rubs \3\ for the
duration of the PHE declared by the Secretary of Health and Human
Services on January 31, 2020, and subsequently renewed. The following
is a brief description of each guidance:
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    \1\ The virus has been named ``SARS-CoV-2'' and the disease it
causes has been named ``Coronavirus Disease 2019'' (COVID-19).
    \2\ For example, as explained in the guidance entitled
``Temporary Policy for Preparation of Certain Alcohol-Based Hand
Sanitizer Products During the Public Health Emergency (COVID-19),''
provided that circumstances described in the guidance are present,
FDA does not intend to take action against firms, for the duration
of the public health emergency, for violations of sections 319(a)(2)
of the Public Health Service Act (42 U.S.C. 247d(a)(2)) or sections
501(a)(2)(B), 502(f)(1), 505, or 582 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B), 352(f)(1), 355, and
360eee-1), which include certain aspects of current good
manufacturing practice, certain labeling requirements, new drug
application requirements, and pharmaceutical distribution supply
chain requirements.
    \3\ FDA uses the term ``hand sanitizer'' throughout this Notice
of Withdrawal, and the referenced guidance documents, to refer to
OTC topical antiseptic rubs for use by consumers, as well as those
for use by healthcare personnel in hospital and healthcare settings.
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     The first guidance,\4\ ``Temporary Policy for Preparation
of Certain Alcohol-Based Hand Sanitizer Products During the Public
Health Emergency (COVID-19),'' communicates FDA's policy for the
temporary preparation of certain alcohol-based hand sanitizer products
by firms that register their establishment with FDA as a
nonprescription over-the-counter (OTC) drug manufacturer, re-packager,
or re-labeler, under the circumstances described in the guidance.
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    \4\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-policy-preparation-certain-alcohol-based-hand-sanitizer-products-during.
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     The second guidance,\5\ ``Policy for Temporary Compounding
of Certain Alcohol-Based Hand Sanitizer Products During the Public
Health Emergency,'' communicates FDA's policy for the temporary
compounding of certain alcohol-based hand sanitizer products by
pharmacists in State- or territory-licensed pharmacies or Federal
facilities and registered outsourcing facilities, under the
circumstances described in the guidance.
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    \5\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-temporary-compounding-certain-alcohol-based-hand-sanitizer-products-during-public-health.
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     The third guidance,\6\ ``Temporary Policy for Manufacture
of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products
During the Public Health Emergency (COVID-19),'' communicates FDA's
policy for the temporary manufacture of alcohol (i.e., ethanol or ethyl
alcohol) by firms for use as the active pharmaceutical ingredient in
alcohol-based hand sanitizers under the circumstances described in the
guidance.
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    \6\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-manufacture-alcohol-incorporation-alcohol-based-hand-sanitizer-products-during.
---------------------------------------------------------------------------

    We appreciate industry's willingness to help supply hand sanitizer
to the market in response to the COVID-19 PHE.
    As explained in these guidance documents, FDA has continually
assessed the needs and circumstances related to these temporary
policies, and as relevant needs and circumstances evolved, FDA made
updates and modifications to these temporary policies. The guidance
documents also state that this assessment includes withdrawing these
temporary policies as appropriate.
    Based on our review of currently available data, we have determined
that the needs and circumstances related to these temporary policies
have evolved such that the temporary policies are no longer needed and
the three guidance documents should be withdrawn.\7\ As explained in
this document, this determination is based on current data that show
that demand for alcohol-based hand sanitizer has decreased and the
supply of hand sanitizer from traditional manufacturers (i.e., firms
other than those that entered into the OTC drug industry for the first
time in order to supply hand sanitizers during the COVID-19 PHE) has
increased. Most consumers and healthcare personnel are no longer
experiencing difficulties accessing alcohol-based hand sanitizer
products.
---------------------------------------------------------------------------

    \7\ We note that withdrawal of these guidance documents will not
cause an assessment of fees on manufacturers of OTC hand sanitizers
under the Over-the-Counter Monograph Drug User Fee Program (OMUFA).
OMUFA fees are distinct from these guidance documents and are
addressed in FDA's Federal Register notice of March 26, 2021 (86 FR
16223), entitled ``Fee Rates Under the Over-the-Counter Monograph
Drug User Fee Program for Fiscal Year 2021.'' As this Federal
Register notice explains, ``FDA will not assess OMUFA facility fees
upon those firms that first registered with FDA on or after the
January 27, 2020 declaration of the COVID-19 Public Health Emergency
(PHE), solely for purposes of manufacturing hand sanitizer products
during the PHE'' (86 FR 16223 at 16225). Additional information is
available in this FDA Federal Register notice and the Health and
Human Services Federal Register notice of January 12, 2021 (86 FR
2420).
---------------------------------------------------------------------------

    During the course of the COVID-19 PHE, FDA has conducted several
surveys of hospital systems to monitor

the supply and sources of alcohol-based hand sanitizer products. Based
on the results of these surveys, current data show that the hand
sanitizer supply disruption in hospitals has decreased significantly
and that hand sanitizer from traditional manufacturers now comprise the
majority of these hospital systems' supply. Specifically, all the
hospital systems that responded to FDA's July 2021 survey on hand
sanitizer supply stated that they are not experiencing a current
disruption in their supply of hand sanitizer, and only 9 percent of
these hospital systems anticipated a future disruption in supply. In
addition, 94 percent of the hospital systems responding to the July
2021 survey reported that the majority of their current hand sanitizer
product is produced by traditional manufacturers. Recent reports also
indicate that there is now a surplus of hand sanitizer products on
retail shelves.\8\ Moreover, certain traditional hand sanitizer
manufacturers indicate that they are able to meet demand and fully
supply the marketplace with hand sanitizer products.\9\ A large
manufacturer of hand sanitizer products has expanded production
capacity and is producing and shipping 300 percent more hand sanitizer
product than in 2019.\10\
---------------------------------------------------------------------------

    \8\ See, e.g., the newspaper articles at https://www.wsj.com/articles/america-is-awash-in-hand-sanitizer-11621522829; https://www.washingtonpost.com/local/last-year-hand-sanitizer-was-a-precious-commodity-now-theyre-giving-it-away/2021/06/24/351f1278-d504-11eb-9f29-e9e6c9e843c6_story.html; https://www.usatoday.com/story/money/2021/04/08/hand-sanitizer-deals-donations-surplus-panic-buying-pandemic/7120815002/ (Refs. 1, 2, and 3).
    \9\ See April 28, 2021, letter from the American Cleaning
Institute/Consumer Healthcare Products Association to FDA, available
at https://www.regulations.gov/comment/FDA-2020-D-1106-0164 (Ref. 4)
(stating that their members ``have the capacity to fully supply the
marketplace'' and have ``increased production of cGMP-compliant
products to meet the demand for both consumer and healthcare
markets,'' at 3).
    \10\ See https://www.gojo.com/en/Newsroom/Press-Releases/2021/PURELL-Brand-Strongly-Positioned-to-Support-Safe-Reopening-of-Schools (Ref. 5).
---------------------------------------------------------------------------

    FDA published its temporary policies for alcohol-based hand
sanitizers in response to the increase in demand for alcohol-based hand
sanitizer products during the COVID-19 PHE and with the understanding
that some consumers and healthcare personnel were experiencing
difficulties accessing alcohol-based hand sanitizer products. Although
the PHE is still ongoing \11\ and there currently is an increase in
COVID-19 cases, the data indicate that: (1) Supply from traditional
manufacturers has increased; (2) the demand for alcohol-based hand
sanitizer that existed earlier in the pandemic has significantly
decreased; and (3) most consumers and healthcare personnel are no
longer having difficulty accessing alcohol-based hand sanitizer
products. Additionally, since declaration of the COVID-19 PHE,\12\ some
hand sanitizer products made by firms that entered the market during
the COVID-19 PHE have been recalled, placed on import alert, and/or
been the subject of compliance actions due to quality and other issues.
Accordingly, the needs and circumstances related to these temporary
policies have evolved such that the temporary policies are no longer
warranted and the guidance documents should be withdrawn.
---------------------------------------------------------------------------

    \11\ Secretary of Health and Human Services,'' Determination
that a Public Health Emergency Exists Nationwide as the Result of
the 2019 Novel Coronavirus'' (originally issued January 31, 2020,
and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx (Ref. 6).
    \12\ The HHS Declaration of a Public Health Emergency is
available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
---------------------------------------------------------------------------

    We note that the recently enacted Coronavirus Aid, Relief, and
Economic Security Act (Pub. L. 116-136) added section 505G to the FD&C
Act (21 U.S.C. 355g). Under section 505G(a)(3) of the FD&C Act, drugs
that were classified as category III \13\ in a tentative final
monograph (TFM) that is the most recently applicable proposal or
determination for such drugs issued under 21 CFR part 330--and that
were not classified in such a TFM as category II for safety or
effectiveness--are not required to have an approved application under
section 505 to be marketed, as long as they are in conformity with the
relevant conditions of use outlined in the applicable TFM and comply
with all other applicable requirements. This includes topical
antiseptic products marketed in conformity with the 1994 TFM for OTC
topical antiseptics (59 FR 31402, June 17, 1994) as further amended by
the 2016 Consumer Antiseptic Rub proposed rule (81 FR 42912, June 30,
2016) and the 2015 Health Care Antiseptics proposed rule (80 FR 25166,
May 1, 2015), as long as they also comply with other applicable
requirements.
---------------------------------------------------------------------------

    \13\ Under the OTC Drug Review, FDA classified drugs as category
III where FDA determined that the available data are insufficient to
classify the drug as generally recognized as safe and effective, and
further testing is required (see 21 CFR 330.10(a)(5)(iii) and
(a)(6)(iii)).
---------------------------------------------------------------------------

    Accordingly, although the temporary policies are being withdrawn as
described above, firms may continue to manufacture alcohol-based hand
sanitizer products without an approved application, provided they
comply with the applicable TFM and other applicable requirements,
including current good manufacturing practice (CGMP) requirements under
section 501(a)(2)(B) of the FD&C Act. Under CGMP, among other things,
drug product manufacturers are required \14\ to test their drug
products prior to release to assure that the drug products meet the
requirements for safety and have the identity and strength, and meet
the quality and purity characteristics, that the drug products purport
to possess. We remind distributors, re-packagers, and importers that
they are also responsible for the safety and quality of the drugs they
introduce into interstate commerce.
---------------------------------------------------------------------------

    \14\ See 21 CFR 211.165 Testing and release for distribution.
---------------------------------------------------------------------------

    Firms preparing alcohol-based hand sanitizer products under FDA's
temporary policies (other than compounding pharmacies) had to register
their facility and list these products in the FDA Drug Registration and
Listing System (DRLS, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/drug-registration-and-listing-system-drls-and-edrls).\15\ We remind firms that registered and submitted drug product
listing(s) for hand sanitizer(s) only but no longer manufacture such
product, or plan to cease manufacturing such product, to deregister and
delist their hand sanitizer product listing(s) by following the
instructions on the Electronic Drug Registration and Listing
Instructions page (https://www.fda.gov/drugs/electronic-drug-registration-and-listing-system-edrls/electronic-drug-registration-and-listing-instructions).
---------------------------------------------------------------------------

    \15\ Every person required to register with FDA must, at the
time of initial registration, list all drugs manufactured, prepared,
propagated, compounded, or processed for commercial distribution.
See section 510(j)(1) of the FD&C Act (21 U.S.C. 360(j)(1)); see
also 21 CFR 207.17 and 207.41. Firms that are required to register
their foreign establishment with FDA must list all known importers
in the United States in their registration in accordance with
section 510(i)(1)(A) of the FD&C Act. See also 21 CFR 207.25(h)(2).
---------------------------------------------------------------------------

    To deregister an establishment using CDER Direct:
     Log into your account and open the previously accepted
version of the registration submission.
     Click on CREATE NEW VERSION. This will create a copy of
the file, keeping the same SetID, but generate a new RootID, Version
Number, and Effective Date.
     For Document type, Select ESTABLISHMENT DE-REGISTRATION
from the drop-down list.
     Click SUBMIT SPL.

    To deregister an establishment from other software applications:
     Create an establishment deregistration SPL document.
     Fill in the SetID with the SetID from your previously
accepted version.
     Enter the appropriate effective date and version number
(generally, one number higher than the previous submission).
     Submit.
    To delist a product using CDER Direct:
     Log into your account and open the previously accepted
version of drug listing submission.
     Click on CREATE NEW VERSION. This will create a copy of
the file, keeping the same SetID, but generate a new RootID, Version
Number, and Effective date.
     Click on the product to edit the Product Data Elements.
Change the Marketing Status from ``ACTIVE'' to ``COMPLETED'' and enter
a Marketing End Date no later than March 31, 2022.
     Save changes and click SUBMIT SPL.
    To delist a product from other software applications:
     Open the previously accepted version of drug listing
submission.
     Create a new version with the same SetID from your
previous submission, but generate a new RootID.
     Enter the appropriate effective date and version number
(generally, one number higher than the previous submission).
     Edit the product data elements. Change the Marketing
Status from ``ACTIVE'' to ``COMPLETED'' and enter a Marketing End Date
no later than March 31, 2022.
     Save and Submit.
    To request additional assistance with deregistration and delisting,
please contact [email protected].

II. Withdrawal Date

    The withdrawal date for the three guidance documents discussed in
this document is December 31, 2021. Accordingly, firms manufacturing
alcohol under the temporary policies for use in alcohol-based hand
sanitizers and firms and compounders preparing alcohol-based hand
sanitizers under the temporary policies must cease production of these
products by December 31, 2021. In addition, firms must by March 31,
2022, cease distribution of any remaining hand sanitizer products that
were prepared under the temporary policies before or on December 31,
2021. After March 31, 2022, FDA intends to cease its temporary policy
of not taking action with regard to distribution of hand sanitizers or
alcohol for use in alcohol-based hand sanitizers prepared consistent
with the circumstances described in the withdrawn guidance documents.
The COVID-19 pandemic is a constantly evolving situation. FDA continues
to assess these circumstances and should the current data change to
indicate that hand sanitizer demand has again outstripped supply prior
to December 31, 2021, FDA may alter these dates. However, firms should
assume these dates will not change and prepare accordingly for
cessation of manufacture and distribution of these products.

III. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500, and are available for viewing by interested persons between 9
a.m. and 4 p.m., Monday through Friday; they are also available
electronically at http://www.regulations.gov. References in the Notice
without asterisks are not available electronically at https://www.regulations.gov because they have copyright restrictions, but they
are on display at the Dockets Management Staff and available for
viewing at the location and times noted above. Some may be available at
the website address, if any, listed with the reference or such website
may provide further information on obtaining copies. FDA has verified
the website addresses, as of the date this document publishes in the
Federal Register, but websites are subject to change over time.

1. Kang, J., ``Retailers Couldn't Stock Hand Sanitizer Fast Enough.
Now They Can't Give It Away,'' The Wall Street Journal, May 20,
2021, (available at https://www.wsj.com/articles/america-is-awash-in-hand-sanitizer-11621522829), accessed August 30, 2021.
2. Dvorak, P., ``Last Year, Hand Sanitizer Was a Precious Commodity.
Now They're Giving It Away,'' The Washington Post, June 24, 2021
(available at https://www.washingtonpost.com/local/last-year-hand-sanitizer-was-a-precious-commodity-now-theyre-giving-it-away/2021/06/24/351f1278-d504-11eb-9f29-e9e6c9e843c6_story.html), accessed
August 30, 2021.
3. Bomey, N., ``Panic Buying? Not Anymore. Suddenly There's a
Surplus of Hand Sanitizer,'' USA Today, April 8, 2021 (available at
https://www.usatoday.com/story/money/2021/04/08/hand-sanitizer-deals-donations-surplus-panic-buying-pandemic/7120815002/), accessed
August 30, 2021.
4. *Letter from James Kim and Barbara Kochanowski, ACI/CHPA, to
Theresa Michele, FDA, April 28, 2021 (available at https://www.regulations.gov/comment/FDA-2020-D-1106-0164), accessed August
30, 2021.
5. Gojo, ``PURELL Brand Strongly Positioned to Support Safe
Reopening of Schools,'' February 22, 2021 (available at https://www.gojo.com/en/Newsroom/Press-Releases/2021/PURELL-Brand-Strongly-Positioned-to-Support-Safe-Reopening-of-Schools), accessed August
30, 2021.
6. *Secretary of the Department of Health and Human Services,
``Determination that a Public Health Emergency Exists Nationwide as
the Result of the 2019 Novel Coronavirus,'' originally issued
January 31, 2020, and subsequently renewed (available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx),
accessed August 30, 2021.

    Dated: October 5, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22108 Filed 10-12-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 75 (Wednesday, April 21, 2021)]
[Notices]
[Page 20683]
[FR Doc No: 2021-08216]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Effectiveness of Exempt Wholesale Generator Status

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

------------------------------------------------------------------------
Lily Solar, LLC........................  EG21-64-000
Trent River Solar, LLC.................  EG21-65-000
PGR Lessee P, LLC......................  EG21-66-000
Aquamarine Westside, LLC...............  EG21-67-000
Aquamarine Lessee, LLC.................  EG21-68-000
Westlands Transmission, LLC............  EG21-69-000
Western Trail Wind, LLC................  EG21-70-000
Helena Wind, LLC.......................  EG21-71-000
Sparta Solar, LLC......................  EG21-72-000
Old 300 Solar Center, LLC..............  EG21-73-000
Silverstrand Grid, LLC.................  EG21-74-000
Ventura Energy Storage, LLC............  EG21-75-000
Chevron Power Holdings Inc.............  EG21-79-000
BRP Alvin BESS LLC.....................  EG21-80-000
Prospero II Master Tenant, LLC.........  EG21-81-000
Prospero Solar II, LLC.................  EG21-82-000
BRP Magnolia BESS LLC..................  EG21-83-000
BRP Odessa Southwest BESS LLC..........  EG21-84-000
BRP Angleton BESS LLC..................  EG21-85-000
BRP Heights BESS LLC...................  EG21-86-000
BRP Brazoria BESS LLC..................  EG21-87-000
------------------------------------------------------------------------

    Take notice that during the month of March 2021, the status of the
above-captioned entities as Exempt Wholesale Generators became
effective by operation of the Commission's regulations. 18 CFR 366.7(a)
(2020).

    Dated: April 15, 2021.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2021-08216 Filed 4-20-21; 8:45 am]
BILLING CODE 6717-01-P


Information Collection Request for

Performance Evaluation Studies of Wastewater Laboratories

June 2010

Prepared by:

U. S. Environmental Protection Agency

Office of Enforcement and Compliance Assurance

Office of Compliance

Agriculture Division

Agriculture Branch

1200 Pennsylvania Ave., NW

Washington, D.C.  20460TABLE OF CONTENTS

  TOC \h \z \t "H1,1,H2,2,TOC1,1"   HYPERLINK \l "_Toc262043121" 1
IDENTIFICATION OF THE INFORMATION COLLECTION	  PAGEREF _Toc262043121 \h
1

 HYPERLINK \l "_Toc262043122" 1(a)	Title and Number of the Information
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 HYPERLINK \l "_Toc262043123" 1(b)	Short Characterization	  PAGEREF
_Toc262043123 \h  1

 HYPERLINK \l "_Toc262043124" 2	NEED FOR AND USE OF THE COLLECTION
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 HYPERLINK \l "_Toc262043125" 2(a)	Need/Authority for the Collection
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 HYPERLINK \l "_Toc262043126" 2(b)	Practical Utility/Users of the Data
PAGEREF _Toc262043126 \h  2

 HYPERLINK \l "_Toc262043127" 3	NONDUPLICATION, CONSULTATIONS, AND OTHER
COLLECTION CRITERIA	  PAGEREF _Toc262043127 \h  3

 HYPERLINK \l "_Toc262043128" 3(a)	Non-duplication	  PAGEREF
_Toc262043128 \h  3

 HYPERLINK \l "_Toc262043129" 3(b)	Public Notice Required Prior to ICR
Submission to OMB	  PAGEREF _Toc262043129 \h  3

 HYPERLINK \l "_Toc262043130" 3(c)	Consultations	  PAGEREF _Toc262043130
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 HYPERLINK \l "_Toc262043131" 3(d)	Effects of Less Frequent Collection
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 HYPERLINK \l "_Toc262043133" 3(f)	Confidentiality	  PAGEREF
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 HYPERLINK \l "_Toc262043135" 4	THE RESPONDENTS AND THE INFORMATION
REQUESTED	  PAGEREF _Toc262043135 \h  5

 HYPERLINK \l "_Toc262043136" 4(a)	Respondents and NAICS/SIC Codes
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 HYPERLINK \l "_Toc262043137" 4(b)	Information Needed	  PAGEREF
_Toc262043137 \h  5

 HYPERLINK \l "_Toc262043138" 5	THE INFORMATION COLLECTED – AGENCY
ACTIVITIES, COLLECTION METHODOLOGY AND INFORMATION MANAGEMENT	  PAGEREF
_Toc262043138 \h  7

 HYPERLINK \l "_Toc262043139" 5(a)	Agency Activities	  PAGEREF
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  PAGEREF _Toc262043140 \h  7

 HYPERLINK \l "_Toc262043141" 5(c)	Small Entity Flexibility	  PAGEREF
_Toc262043141 \h  7

 HYPERLINK \l "_Toc262043142" 5(d)	Collection Schedule	  PAGEREF
_Toc262043142 \h  7

 HYPERLINK \l "_Toc262043143" 6	ESTIMATING THE BURDEN AND COST OF THE
COLLECTION	  PAGEREF _Toc262043143 \h  8

 HYPERLINK \l "_Toc262043144" 6(a)	Estimating Respondent Burden
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 HYPERLINK \l "_Toc262043145" 6(b)	Estimating Respondent Costs	  PAGEREF
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 HYPERLINK \l "_Toc262043146" 6(c)	Estimating Agency Burden and Costs
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 HYPERLINK \l "_Toc262043147" 6(d)	Estimating the Respondent Universe
and Total Burden and Costs	  PAGEREF _Toc262043147 \h  11

 HYPERLINK \l "_Toc262043148" 6(e)	Bottom Line Burden Hours and Cost
Tables	  PAGEREF _Toc262043148 \h  12

 HYPERLINK \l "_Toc262043149" 6(f)	Reasons for Change in Burden
PAGEREF _Toc262043149 \h  12

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_Toc262043150 \h  12

 HYPERLINK \l "_Toc262043151" APPENDIX A: LIST OF CHEMISTRY &
MICROBIOLOGY ANALYTES AND WET TEST METHODS	  PAGEREF _Toc262043151 \h
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 HYPERLINK \l "_Toc262043152" APPENDIX B: LIST OF TOP CHEMISTRY &
MICROBIOLOGY ANALYTES AND WET TEST METHODS AND TIMES FOR ANALYZING
PAGEREF _Toc262043152 \h  16

1	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a)	Title and Number of the Information Collection tc "1(a)	Title and
Number of the Information Collection" \f C \l 2

Performance Evaluation Studies of Wastewater Laboratories. OMB Control
No. 2080-0021, ICR No. 0234.10.

1(b)	Short Characterization tc "1(b)	Short Characterization" \f C \l 2

This is a request for a new Information Collection Request (ICR) to
support the collection of Proficiency Testing (PT) data to test the
performance of laboratories that conduct discharge analyses for the
Discharge Monitoring Report – Quality Assurance study program
(DMR-QA). This request will replace the expiring ICR (Performance
Evaluation Studies of Water and Wastewater Laboratories (OMB Control No.
2080-0021, EPA ICR No. 0234.09)).  This ICR refers only to DMR-QA.
Therefore, the figures for burdens only support DMR-QA.  EPA is
requesting a standard three-year clearance for this ICR.

Chemical monitoring data for drinking water and wastewater are submitted
from a variety of laboratories to the United States Environmental
Protection Agency (EPA) every year.  These results must be relied on by
EPA, as they form the primary basis for its regulatory decisions.  In
order to provide an objective demonstration that these laboratories are
submitting reliable information, the subject Performance Evaluation (PE)
studies were developed.  Participation in the Discharge Monitoring
Report - Quality Assurance (DMR-QA) studies is mandatory for major
wastewater dischargers and selected minor dischargers under the National
Pollutant Discharge Elimination System (NPDES) permit.  Major
dischargers are defined as facilities that discharge at least 1 million
gallons of waste water per day and also those facility(s) servicing at
least 10,000 homes.  Minor dischargers are selected to monitor the
analytes/toxics discharged by the facility.

EPA originally administered the preparation of test standards for the
program as part of the Agency’s mandate to assure the quality of
environmental monitoring data submitted by NPDES permit holders
(permittees). Currently, preparation, distribution and grading of the
test standards for have been privatized to lessen EPA(s burden in
carrying out this mandate.  Private sector companies, known as
Proficiency Testing (PT) providers, manufacture and distribute test
samples to the contract and in-house laboratories.  The laboratories
submit their analytical results to the PT providers for evaluation.  The
PT providers evaluate the submitted data and send the graded results
back to the laboratories.  These laboratories then forward copies of
their graded data to their permittee clients, who will review the
results and forward the data to their designated certifying/enforcement
authorities.  Providers also send electronic copies of the graded
results to the designated certifying/enforcement authorities and to EPA.
 These graded results include the names and addresses of the
laboratories, the analytes that were tested, the concentration of the
analyte, and the acceptance criteria and evaluations.

EPA is required to conduct this ICR analysis because more than nine
non-Federal entities will be asked to respond to these data requests.
Because state agencies use the resulting data for their own laboratory
certification/enforcement programs, and are not reporting any
information from the PT studies to EPA, they do not incur any burden
under this ICR.  In addition, cost and burden to PT Providers are not
considered in this ICR because the vendor costs associated with this
program are accounted for in the pricing of their standards (i.e., the
costs incurred by the Providers is factored into the cost of the PT
standards).

The total annual burden and labor costs incurred by the 6,589 permittees
associated with this ICR are estimated to be 41,511 hours and $2,461,426
per year over the 3-year ICR period (2011-13).  EPA estimates that it
takes 6.3 hours and costs $373.57 per year per respondent to comply with
this requirement.  Respondent labor costs are linked with the time it
takes to read and understand the annual DMR-QA announcement sent by EPA,
plan activities, analyze PT standards, report information to the PT
providers, and maintain records.  Respondent operation and maintenance
(O&M) costs are associated with purchasing the PT standards.  No costs
or burdens to PT Providers or state regulatory agencies are associated
with this ICR.

2	NEED FOR AND USE OF THE COLLECTION

2(a)	Need/Authority for the Collection tc "2(a)	Need/Authority for the
Collection" \f C \l 2

Laboratory Performance Evaluation (PE) studies are designed to fulfill
the need to monitor the quality of analytical data for select critical
analytes within major point-source discharge samples.  Results from the
PE studies over time have generally shown a slow but regular improvement
in average performance by the laboratories producing the monitored data.
 By helping laboratories identify and correct analytical problems, the
PE studies are also responsible for documented improvement in this data.

Public Law 92-500, the Federal Water Pollution Control Act Amendments of
1972, and the related regulations in 40 CFR part 136, required extensive
analysis of water and wastewater samples by EPA, state, local government
and private laboratories, to maintain ambient water quality and control
point-source discharges.  These monitoring requirements were continued
in the Clean Water Act of 1987 § 308(a) (Federal Water Pollution
Control Act, Public Law 100-4, 33 U.S.C. § 1318).  EPA bases many
important decisions upon this data.  The data quality depends heavily
upon the availability of capable laboratory analysis at all levels and
reliability must be ensured.

2(b)	Practical Utility/Users of the Data tc "2(b)	Practical
Utility/Users of the Data" \f C \l 2

States and laboratory personnel will use the results of these studies to
identify problems associated with laboratory analysis and substandard
facility discharges.  This will improve the quality of water data in
critical monitoring areas and the quality of facility discharge returned
to the environment.  These studies have demonstrated that problems exist
and arise periodically with all dischargers and water testing
laboratories; without future studies, many such problems will go
unrecognized and unresolved.  Results from the DMR-QA studies are used
to highlight NPDES facilities and laboratories with apparent analytical
problems that should be inspected on-site by state regulatory personnel.
 Results from the PT studies are used by State personnel as a major part
of the basis for certifying laboratories to produce required regulatory
data and as a base for potential regulatory enforcement.

3	NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

3(a)	Non-duplication tc "3(a)	Non-duplication" \f C \l 2

The DMR-QA accepts data and results from any of the other federally
sponsored water quality programs, such as the Water Pollution (WP)
program, as long as the laboratories meet the condition that they
perform the PE sample analyses between January 1st and the last day of
the DMR-QA study.  The DMR-QA study commences on or around March 15th,
and concludes on or around June 30th of each year.  EPA has granted
waivers to 5 states to use their state laboratory certification program
in lieu of their permittees participating in DMR-QA. Four of these
waivers have been granted since the last ICR was renewed in December
2007.

3(b)	Public Notice Required Prior to ICR Submission to OMB tc "3(b)
Public Notice Required Prior to ICR Submission to OMB" \f C \l 2

In compliance with the Paperwork Reduction Act, a notice of this
Information Collection Request ICR was published in the Federal Register
on June 16, 2010 (75 FR 34110),

3(c)	Consultations

The DMR-QA has been administered by the EPA for over 30 years.  The
Office of Research and Development initiated and administered the
program until the responsibility was assigned to Office of Enforcement
and Compliance Assurance (OECA).  OECA will consider any comments
received and make appropriate adjustments to the program.  The seven PT
providers are accredited by the American Association for Laboratory
Accreditation (A2LA).

A2LA is a nonprofit, non-governmental, public service, membership
society.  The mission of A2LA is to provide comprehensive services in
laboratory accreditation and laboratory-related training.

The list of PT providers is available at  HYPERLINK
"http://a2la.org/dirsearchnew/nelacptproviders.cfm"
http://a2la.org/dirsearchnew/nelacptproviders.cfm .

EPA also contacted the PT Providers; three responded, all wish to remain
anonymous.  The PT Providers were asked to give their input on the
estimate for time burdens as well as the fees which labs need to pay for
samples provided by the PT Providers.  The three PT Providers that
responded indicated that it cost on average $280 to $320 per laboratory
for samples.  An average was obtained of $300 per laboratory.  It must
be kept in mind that this is the cost that in-house and contract
laboratories pay, and this is passed onto the permittee.  Therefore, if
a lab is contracted by several permittees, then EPA considers that the
$300 will be distributed evenly among the permittees.  However, if a
permittee employs an in-house laboratory, the permittee is burdened with
the entire cost of obtaining samples ($300) as well as the labor costs
of the laboratory.  Since the ratio of in-house and contract
laboratories is unknown, an average was obtained for all laboratories
and a ratio of 0.633 permittee per laboratory was used.  This ratio is
the same as used in the 2007 ICR.  Therefore, the cost of obtaining
samples is estimated to be $190 per permittee, using the ratio of 0.633
laboratory per permittee.

3(d)	Effects of Less Frequent Collection tc "3(d)	Effects of Less
Frequent Collection" \f C \l 2

The current frequency for the DMR-QA is judged to be the minimum needed
to assess the accuracy of data production required by discharge permits.
 Under DMR-QA, laboratories producing data are expected to demonstrate
adequate analytical proficiency once each year for each analyte they
test routinely for their NPDES permittee clients.  Collecting water
quality data less than once per year to measure the accuracy of
laboratory work would potentially delay corrective actions required by
the permittee and therefore compromise discharge water quality.

3(e)	General Guidelines

This ICR was prepared in accordance with the October 2009 version of the
ICR Handbook developed by EPA's Office of Environmental Information,
Office of Information Collection, Collection Strategies Division.  The
ICR Handbook provides the most current instructions for ICR preparation
to ensure compliance with the 1995 Paperwork Reduction Act (PRA)
Amendments and OMB's implementing guidelines.

EPA believes participation in these studies is a reasonable requirement
for all laboratories routinely producing data for environmental water
regulation.  Any public health data on drinking waters, ambient waters
or effluents under regulation deserve the minimal quality assurance
check that these studies represent.

3(f)	Confidentiality tc "3(f)	Confidentiality" \f C \l 2

This information collection does not require respondents to disclose
confidential information.

3(g)	Sensitive Questions tc "3(g)	Sensitive Questions" \f C \l 2

No questions of a sensitive nature are included in any of the
information collection requirements outlined in this ICR.

4	THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a)	Respondents and NAICS/SIC Codes  tc "4(a)	Respondents and NAICS/SIC
Codes" \f C \l 2

Respondents in DMR-QA studies are NPDES permittees designated by the EPA
region or state with permitting responsibility and the laboratories
doing chemical/microbiological analysis and whole-effluent toxicity
testing for these major dischargers.  These respondents are most likely
from the following SIC Codes:

2011 - through 3999 - Manufacturers

4941 - Water supply systems

4952 - Sewerage systems

8734 - Water testing laboratories

4(b)	Information Needed

4(b)(i)   Data Items

In all laboratory PE studies, the data result from analyses of synthetic
samples that contain known amounts of specific compounds, usually
dissolved in reagent water.  In DMR-QA studies, the compounds are those
of primary interest with regard to the monitoring requirements in the
NPDES permits.  All studies also collect sufficient data to properly
identify and characterize the respondents.  Each respondent reports only
data for that portion of the study analytes for which they wish to be
certified or as directed by the responsible regulatory official.

4(b)(ii)  Respondent Activities tc "4(b)(ii)	Respondent Activities" \f C
\l 3

The primary burden involves analyzing and reporting results for relevant
study samples according to instructions. Based on the current DMR-QA
study, 6,589 respondents participate in certification studies.

The DMR-QA program requires 6,589 permittees to submit results annually.
 A percentage of these permittees do all the work onsite themselves,
using in-house laboratories. The remaining permittees contract at least
some of the analysis to a commercial laboratory(s).  The commercial
laboratory may do work for many permittees; the DMR-QA results would
then be sent to these permittees.  Therefore, there are fewer labs than
permittees.  However, EPA does not have data on how many in-house
laboratories and contract laboratories are used.  Furthermore, EPA does
not track how many laboratories participated in one or more studies or
how many permittees participated in only chemistry and microbiology and
those that also participated in WET testing.  EPA is estimating the
“maximum” impact of the DMR-QA program on the regulated community.
EPA will assume that all 6,589 permittees will fulfill requirements for
the top 10 chemistry & microbiology analytes and the top 10 WET test
methods.  EPA believes this ICR may overestimate the burden because not
all permittees do WET testing.  (See Appendix B for a list of the top 10
chemistry & microbiology analytes and the top 10 WET test methods).

To calculate the burden incurred on laboratories performing PE samples,
EPA used a ratio of 0.633 laboratories per NPDES permittee.  This ratio
was calculated based on data procured by 4 PT Providers in 2006.  EPA
assumes that the ratio of laboratories per permittee has not changed
significantly since the last ICR was approved.  Based on this ratio
(0.633 laboratories per NPDES permittee) and that there are 6,589
permittees participating in the DMR-QA, EPA estimates there are a total
of 4,171 laboratories performing PE studies under DMR-QA.   To provide
an estimate of respondent burden for the WET testing portion of DMR-QA,
EPA determined that an average of 4.77% of all laboratories
participating in DMR-QA perform WET PE tests, or 227 laboratories.  This
percentage is also based on the information from the 4 providers
received in 2006.

EPA is not estimating the burden for the PT Providers, because this
burden is internalized in the cost of obtaining PE samples from the PT
Providers.

Respondents (permittees) will participate in the following activities:

Read Instructions: Each of the 6,589 respondents will read the
instructions provided by EPA.

Plan Activities:  Each of the 6,589 respondents will incur burden to
plan activities associated with the PT studies.

Analyze Chemistry and Microbiology Analytes:  EPA assumes that all 6,589
respondents will participate in the PT studies for microbiology, trace
metals, demands, minerals, nutrients, and miscellaneous analytes as
required by respondents’ permits.  EPA assumes that 4,171 in-house and
contract laboratories will do the work for the 6,589 permittees.

Analyze WET:  EPA assumes that all 6,589 permittees will participate in
the PT studies for WET.  It is assumed that 227 in-house and contract
laboratories will do the work for the 6,589 permittees.

Report Results:  Each of the 6,589 respondents will incur burden to
report its study results to the PT provider.

Maintain Records:  Each of the 6,589 respondents will incur burden to
maintain records associated with the PT study.

5	THE INFORMATION COLLECTED – AGENCY ACTIVITIES, COLLECTION
METHODOLOGY AND INFORMATION MANAGEMENT

5(a)	Agency Activities tc "5(a)	Agency Activities" \f C \l 2

EPA has reduced its activity related to this information collection to
that of providing general guidance and oversight for the PT Providers
and the participating laboratories on an as needed basis.

5(b)	Collection Methodology and Management tc "5(b)	Collection
Methodology and Management" \f C \l 2

EPA will notify the permittee of their requirement to participate in the
relevant PE program annually.  The permittee’s in-house or contract
laboratory will then select an accredited private PT Provider to provide
them with the appropriate samples.  The testing facility will then send
the analysis data of these samples to the PT Provider.  The permittee
will use the form approved by OMB to report DMR-QA results.  This form
will be available in two formats: a hard copy that will be part of the
announcement which is mailed annually and an online PDF form, available
on the EPA website.  This PDF form can be filled out and then printed
for submission.  The PT Provider will send evaluations of the submitted
data back to the permittee and the designated certifying/enforcement
authority. PT Providers will also send summary data in electronic form
to EPA for archiving.

5(c)	Small Entity Flexibility tc "5(c)	Small Entity Flexibility" \f C \l
2

The major requirement under Small Business Regulatory Enforcement
Fairness Act (SBREFA) is a regulatory flexibility analysis of all rules
that have a "significant economic impact on a substantial number of
small entities."  Since this data request is not part of a rule, this
ICR is not subject to SBREFA.

5(d)	Collection Schedule tc "5(d)	Collection Schedule" \f C \l 2

EPA determines the requirements for the frequency that a permittee must
demonstrate proficiency by passing a PE study. The study typically
starts on or around March 15th and ends on or around June 30th. .The
participating permittees’ in-house/contract laboratories demonstrate
their proficiency by passing a PE study conducted by an accredited PT
Provider for a fee. The PT Provider must submit the results of each
study to the state and EPA regional coordinator, as well as the EPA
National Coordinator.

In summary: each participating in-house or contract laboratory must
report test results to the PT Provider once a year. The PT Provider must
electronically submit the results of all studies they conduct to
participating permittees and state and EPA regional coordinators.
Participating permittees must re-qualify for each analyte it reports one
year from the last certification that it received.

6	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

This section describes the estimated average annual burden and costs for
the information collection activities for PT studies that will be
conducted by laboratories.  For this data submission, PT providers and
state agencies and EPA have no burden and costs; this is discussed
further in Section 6(a).  The Agency's burden and cost estimates are
outlined in Section 6(c).

To estimate the costs, EPA made assumptions about the burden associated
with activities that would likely be needed to fulfill the request.  EPA
emphasizes that the per-respondent estimates represent the average
burden and cost over the 3-year period covered by this ICR (2011-2013).
Some respondents may incur higher costs and some will fall below the
average.  EPA made the assumption that all respondents perform all the
tests included in this analysis.  As a result, the time burden may be a
bit on the higher end.

Burden and costs are not distinguished by categorized entities, public
(federal, state and local government dischargers) and private
(commercial, industrial and others) sectors, because EPA currently does
not track this information.  EPA’s best estimate is that from the
total of 6,589 permittees, there are 3,148 state and local government
facilities and 3,441 commercial facilities

6(a)	Estimating Respondent Burden tc "6(a)	Estimating Respondent Burden"
\f C \l 2

The average annual respondent burden (in labor hours) for permittees is
shown in Table 6.1.  PT Providers conduct the studies, removing this
burden from EPA.  Participating laboratories receive samples from the PT
Provider, return test results to the PT Providers and the PT Providers
evaluate the data and send reports to the laboratories, the state
accrediting authorities and EPA.  The total burden on the laboratories
is 41,511 hours, with an average of 6.3 hours per respondent (41,511
total hours divided by 6,589 permittees). This estimate includes burden
for participating laboratories to read instructions, plan activities,
analyze samples, submit data to the PT vendors, and maintain records.

EPA assumes that the respondent burden will be divided among three labor
categories:  manager, chemist, and records clerk.  The labor associated
with each of the ICR activities are discussed in more detail below.

Read Instructions:  EPA assumes that each of the 6,589 respondents will
require 0.5 hour to read the instructions provided by EPA.  The burden
will be evenly divided between a manager and chemist.

Plan Activities:  EPA assumes that the manager of each laboratory will
require 0.5 hours to plan activities associated with the PT studies. The
burden will be divided between a manager and chemist.

Analyze Chemistry and Microbiology Analytes:  A total of 6,589
permittees are expected to use a total of 4,171 laboratories (a ratio of
0.633 laboratories for every permittee).  Analysis is assumed to require
approximately 1.8 hours to analyze PT standards for the top 10 analytes.
 All hours will be incurred by a chemist.  See Appendix B for these
tests and the estimated time for an analysis.  These estimates assume
that the laboratory is adding a DMR-QA sample to the normal processing
that occurs in the laboratory using an already calibrated
instrument/process.

Analyze WET:  A biologist or project manager constructs the test
chambers and records organism mortality (morbidity) of test organisms
while a chemist analyzes the water chemistry.  Biologists and chemists
are assumed to require 2.4 hours to analyze PT standards for WET.  It is
assumed that 227 laboratories do this work for all 6,589 permittees.
These estimates assume that the laboratory is adding a DMR-QA sample to
the normal processing that occurs in the laboratory using an already
calibrated instrument/process.

Report Results:  EPA assumes that each of the 6,589 respondents will
require 1.0 hours to report the results of the study to the PT Provider.
 The burden will be divided between a manager and records clerk.

Maintain Records:  EPA assumes that a records clerk in each of the 6,589
laboratories will require 0.1 hours to maintain the files from the PT
study.

6(b)	Estimating Respondent Costs tc "6(b)	Estimating Respondent Costs"
\f C \l 2

Table 6.2 shows the annual average costs for laboratories over the
3-year ICR period.  Average annual labor costs for all 6,589 permittees
are estimated to be $1,209,516.  Average annual O&M costs are estimated
to be $1,251,910.  EPA estimates each laboratory will incur an annual
average labor plus non-labor cost of $373.57 for this data collection
effort. (see Table 6.2).

6(b)(i)   Respondent Labor

The labor cost was arrived at by estimating the amount of labor required
to participate on an annual basis in the DMR-QA study.  Labor costs are
based on information provided by the U.S. Department of Labor
Statistics, May 2008, National Industry Specific Occupational Employment
and Wage Estimate. The labor categories include a manager at an hourly
rate of $51.23, a data entry clerical person at an hourly rate of
$13.25, and a skilled technician or chemist to conduct the measurements
at an hourly rate of $28.16.  These values were adjusted for inflation
using the U.S. Department of Labor Bureau of Labor Statistics’s CPI
calculator ( HYPERLINK "http://data.bls.gov/cgi-bin/cpicalc.pl"
http://data.bls.gov/cgi-bin/cpicalc.pl ).  Table 6.2 lists the estimated
burden and costs for labor related to each activity.  The annual
respondent labor cost, for all 6,589 respondents is estimated to be
$1,196,910 for 41,511 hours.

6(b)(ii)   Respondent Operation and Maintenance Costs

Operation and Maintenance (O&M) costs for laboratories include all costs
related to providing personnel with the space, equipment and materials
necessary to perform the tasks required by this ICR.  Since laboratories
are driven by their compliance monitoring requirements to purchase the
analytical instrumentation and computers and not by this ICR, no capital
costs are be considered associated with this ICR. Only the costs
associated with purchasing the PT standards is appropriate for
consideration in this category.

Permittees may participate in the PT studies for some or all of the
chemistry, microbiology analytes and WET test methods (refer to Appendix
A for a list of chemistry and microbiology analytes and WET test
methods).  The cost of the PE samples varies with the costs for the
analytes, microbiological and WET testing required for each calendar
year. This is complicated by the fact that the participants in any given
study need not analyze all of the samples available for that study, only
the ones that are required by their permits. EPA estimated a cost of
$300 per laboratory based on feedback from PT Providers who did an
analysis of the average cost of buying PE samples.

Because EPA does not have sufficient information to estimate how many
analytes are contained in the PT samples sent to each laboratory, EPA
assumes that a single PT sample contains standards for the top ten
analytes for chemistry and microbiology and the top 10 WET test methods,
based on information from the PT Providers.  Therefore, laboratories
participating in the chemistry and microbiology PT study are assumed to
receive and run analyses for 10 analytes.  Similarly, those
participating in the PT study for WET would receive samples for each of
10 WET test methods.  EPA estimates the costs of obtaining PT samples to
be $300 per laboratory and $190 per permittee (respondent).  Average
annual O&M costs (fees for PE samples) for the respondents is estimated
to be $1,251,910.

6(b)(iii)   Capital/Startup Operating and Maintenance (O&M) Costs

There are no Capital/Startup costs associated with this information
collection.  The annual Operating and Maintenance costs associated with
this ICR are estimated to be $190 per respondent.

6(c)	Estimating Agency Burden and Costs tc "6(c)	Estimating Agency
Burden and Costs" \f C \l 2

Since EPA’s role has been reduced to an advisory level only, there is
no longer any burden to the Agency, other than the time required to put
together the annual announcement and printing and mailing costs of the
annual announcement.  On average, 6,750 announcements are printed
annually, to send out to permittees, PT Providers, state and regional
coordinators as well as spare copies.  The annual burden is estimated
below:

Maintaining records of active participants in the program:  80 hours

Putting together the annual announcement and answering questions:  480
hours (40 hours/month)

Cost of printing 6,750announcements:  $5,000

Cost of mailing announcements:  $6,000

Total annual burden and cost to EPA:  560 hours and $11,000

6(d)	Estimating the Respondent Universe and Total Burden and Costs tc
"6(d)	Estimating the Respondent Universe and Total Burden and Costs" \f
C \l 2

The only respondents for this ICR are NPDES permittees.  They may use
contract laboratories to perform the work, but the burden is considered
to be upon the permittees, since they bear the costs of labor and
operations & maintenance.  As itemized in section 6(b), the annual
respondent burden is 6.3 hours and $373.57 per participant.  The total
annual respondent burden is 41,511 hours and $2,461,426 for 6,589
participants. Currently, there are 7 PT Providers.  PT Providers’
burdens are not assessed in this ICR because their cost burden for this
ICR is part of the estimated PE sample cost burden for the laboratories.
 Burden and costs to EPA is minimal, being limited to the drafting of
the annual announcement and printing/mailing costs, which come to a
total of 560 hours and $10,962.21 on an annual basis.

6(e)	Bottom Line Burden Hours and Cost Tables tc "6(e)	Bottom Line
Burden Hours and Cost Tables" \f C \l 2

The bottom line burden hours and costs for this ICR are shown in Table
6.3.  This includes the burden and costs to the 6,589 laboratories that
are affected by this ICR.

6(f)	Reasons for Change in Burden

Participation in the DMR-QA PE study has decreased from an estimated
average of 7,516 to 6,589 since the last renewal of this ICR.  This is
due to EPA granting a waiver to four additional states, allowing them to
employ their state laboratory certification program as an adequate
substitute for the federal DMR-QA program.

Labor and Operation & Maintenance costs were updated since the previous
renewal of this ICR.  Operation & Maintenance costs reflect the costs of
obtaining PE samples from the PT Providers.  The estimated average cost
of obtaining PE samples increased from $165 per respondent (permittee)
to $190 per respondent.

6(g)	Burden Statement

The average annual respondent burden for each permittee is estimated to
be 6.3 hours per response.  This estimate includes the total time,
effort, or financial resources expended by permittees to gather and
report information, and develop and maintain record.

Burden Statement:  The reporting burden for data collections included in
this ICR is detailed above.  The total annual respondent burden (for
years 2011 – 2013) imposed by these collections is estimated to be
47,351 hours, or 6.3 hours per respondent per year.  Estimates include
time for reading instructions, planning activities, analyzing standards,
reporting results, and maintaining records.

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-OECA-2010-0413, which is available for   SEQ CHAPTER \h \r 1
online viewing at  HYPERLINK "http://www.regulations.gov"
www.regulations.gov ,   SEQ CHAPTER \h \r 1 or in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC), EPA
West, Room 3334, 1301 Constitution Ave., NW, Washington, DC.  The EPA/DC
Public Reading Room   SEQ CHAPTER \h \r 1 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<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.

Use EPA’s electronic docket and comment system at  HYPERLINK
"http://www.regulations.gov" www.regulations.gov , to submit or view
public comments, access the index listing of the contents of the docket,
and to access those documents in the docket that are available
electronically.  Once in the system, select “docket search,” then
key in the docket ID number identified above.   Please note that EPA’s
policy is that public comments, whether submitted electronically or in
paper, will be made available for public viewing at  HYPERLINK
"http://www.regulations.gov" www.regulations.gov   as EPA receives them
and without change, unless the comment contains copyrighted material,
CBI, or other information whose public disclosure is restricted by
statute.    SEQ CHAPTER \h \r 1 For further information about the
electronic docket, go to  HYPERLINK "http://www.regulations.gov"
www.regulations.gov .  Also, you can send comments by mail 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-OECA-2010-0413 and OMB
control number 2080-0021 in any correspondence.

APPENDIX   SEQ APPENDIX \* ALPHABETIC  A : LIST OF CHEMISTRY &
MICROBIOLOGY ANALYTES AND WET TEST METHODS

APPENDIX B: LIST OF TOP CHEMISTRY & MICROBIOLOGY ANALYTES AND WET TEST
METHODS AND TIMES FOR ANALYZING

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