[Federal Register Volume 87, Number 23 (Thursday, February 3, 2022)]
[Notices]
[Pages 6170-6171]
[FR Doc No: 2022-02169]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-2008-0719; FRL-9526-01-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; National Pollutant Discharge Elimination
System Program (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), ``Information Collection Request
(ICR) Supporting Statement for The National Pollutant Discharge
Elimination System Program (Renewal)'' (EPA ICR Number 0229.25, OMB
Control Number 2040-0004) to the Office of Management and Budget (OMB)
for review and approval in accordance with the Paperwork Reduction Act.
This is a proposed extension of the ICR, which is currently approved
through March 31, 2022. Public comments were previously requested via
the Federal Register on July 29, 2021 during a 60-day comment period.
This notice allows for an additional 30 days for public comments. A
fuller description of the ICR is given below, including its estimated
burden and cost to the public. An agency may not conduct or sponsor and
a person is not required to respond to a collection of information
unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before March 7, 2022.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
2008-0719, t online using www.regulations.gov (our preferred method) 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.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Joshua Baehr, National Program Branch,
Water Permits Division, OWM Mail Code: 4203M, Environmental Protection
Agency, 1201 Constitution Ave. NW, Washington, DC 20460; telephone
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 202-566-
1744. For additional information about EPA's public docket, visit
http://www.epa.gov/dockets.
    Abstract: This Information Collection Request (ICR) renews the
National Pollutant Discharge Elimination System (NPDES) Program ICR and
consolidates the information collection burden and costs associated
with activities previously reported in 18 of the NPDES program or
NPDES-related ICRs. It calculates the information collection burden and
costs associated with the NPDES program, identifies the types of
activities regulated under the NPDES program, describes the roles and
responsibilities of state governments and the Agency, and presents the
program areas that address the various types of regulated activities.
This renewal documents the addition of the burden and costs for the
four existing NPDES ICRs listed below. Once this renewal ICR is
approved, the following ICRs will be discontinued: Public Notification
Requirements for Combined Sewer Overflows (CSOs) in the Great Lakes
Basin (OMB control no. 2040-0293, EPA ICR 2562.03, expiration date 04/
30/24); Effluent Limitation Guidelines and Standards for the Dental
Category (OMB control no. 2040-0287, EPA ICR no. 2514.03, expiration
11/30/23); 2020 NPDES Multi-Sector General Permit (MSGP) for Industrial
Stormwater Discharges (OMB control no. 2040-0300, EPA ICR no. 2612.02,
expiration 03/31/24); and NPDES Electronic Reporting Rule--Phase 2
Extension (OMB Control No.: 2020-0037, EPA ICR No. 2617.02, expiration
12/31/2023).
    The Clean Water Act (CWA) provides that NPDES permits are required
for the discharge of pollutants to waters of the United States. The CWA
requires EPA to develop and implement the NPDES permit program. CWA
section 402(b) allows states to acquire authority to administer the
NPDES program, enabling them to issue NPDES permits for discharges
within the state. At present, 47 states and the U.S. Virgin Islands are
authorized to administer the NPDES permit program. In states that do
not have authority for these programs, the Agency administers the
program and issues NPDES permits. Because some permit applications are
processed by states and some by EPA, this ICR calculates government
burden and cost for both authorized states and EPA. See Appendix F.1
for a copy of the authorizing regulation.
    Form Numbers: EPA Form 3510-1; EPA Form 3510-2A; EPA Form 3510-2B;
EPA Form 3510-2C; EPA Form 3510-2D; EPA Form 3510-2E; EPA Form 3510-2F;
EPA Form 3510-2S.
    Respondents/affected entities: Any point source discharger of
pollutants, publicly owned and privately owned treatment works (POTWs
and PrOTWs), industrial dischargers to POTWs and PrOTWs, industrial and
commercial dischargers to water of the United States, sewage sludge
management and disposal operations, large vessels, dischargers of
stormwater, construction sites, municipalities, pesticide applicators,
local and state governments.
    Respondent's obligation to respond: Mandatory, sections 301, 302,
304, 306, 307, 308, 316(b), 401, 402, 403, 405, and 510 of the CWA; the
1987 Water Quality Act (WQA) revisions to CWA section 402(p); 40 CFR
parts 122, 123, 124, and 125 (and parts 501 and 503 for Biosolids); and
the Great Lakes Critical Programs Act (CPA).
    Estimated number of respondents: 827,180 (total). (Includes 637
States/Tribes/Territories).
    Frequency of response: Varies depending on the specific response
activity and can range from ongoing and monthly to once every five
years.
    Total estimated burden: 31,143,503 hours (per year). Burden is
defined at 5 CFR 1320.03(b).
    Total estimated cost: $1,732,287,018 (per year), includes
$22,999,181 annualized capital or operation & maintenance costs.
    Changes in the estimates: The majority of the burden hour increase
occurred as a result of an increase in EPA's estimates of permittee
respondents, which is largely attributed to improvements in the NPDES
Integrated Compliance Information System (ICIS-NPDES) database,
implementation of the Electronic Reporting Rule Phase 1, and refined
estimates. This ICR eliminates the initial permit application and
compliance activities for existing Cooling Water Intake Structure
(CWIS) facilities, as these actions have been completed by all existing
CWIS facilities. The compliance and administration of small vessels
general permit (sVGP) has been removed, which lowered the number of
vessel respondents significantly.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2022-02169 Filed 2-2-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Notices]
[Pages 67168-67169]
[FR Doc No: 2013-26855]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Sixth Annual Sentinel Initiative; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing the following
public workshop entitled ``Sixth Annual Sentinel Initiative.'' Convened
by the Engelberg Center for Health Care Reform at the Brookings
Institution and supported by a cooperative agreement with FDA, this 1-
day workshop will bring the stakeholder community together to discuss a
variety of topics on active medical product surveillance. Topics will
include an overview of the status of FDA's Sentinel Initiative and
future plans, highlights from key Mini-Sentinel and related activities,
and an update on active surveillance collaborations and program
extensions. In addition, this workshop will engage stakeholders to
discuss current and emerging Sentinel projects and facilitate
stakeholder feedback and input on Sentinel projects that would be
appropriate to determine the feasibility of using Sentinel to evaluate
drug safety issues that may require regulatory action (e.g., labeling
changes, postmarketing requirements (PMRs), or postmarketing
commitments (PMCs)). This workshop satisfies an FDA commitment that is
part of the fifth authorization of the Prescription Drug User Fee Act
(PDUFA V).
    Date and Time: The public workshop will be held on January 14,
2014, from 9 a.m. to 4 p.m.
    Location: The public workshop will be held at the Washington
Marriott at Metro Center, 775 12th Street NW., Washington, DC 20001.
For additional travel and hotel information, please refer to http://www.cvent.com/d/jcqhyy. (FDA has verified the Web site addresses
throughout this notice, but FDA is not responsible for subsequent
changes to the Web sites after this document publishes in the Federal
Register).
    Contact Person: Carlos Bell, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6358, Silver Spring, MD 20993,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
email<EMAIL_ADDRESS>    Registration: To attend the public workshop, you must register
before January 14, 2014, by visiting http://www.cvent.com/d/jcqhyy.
Early registration is recommended. There will be no onsite
registration. When registering, please provide the following
information: Your name, title, company or organization (if applicable),
postal address, telephone number, and email address. There is no
registration fee for the public workshop; but because seating is
limited, registration will be on a first-come, first-served basis. A 1-
hour lunch break is scheduled; however, food will not be provided.
There are multiple restaurants within walking distance of the hotel.
    If you need special accommodations due to a disability, please
contact Joanna Klatzman at the Brookings Institution (email:
<EMAIL_ADDRESS>at least 7 days in advance.
    Meeting Materials: All event materials will be available to
registered attendees via email prior to the workshop and will be posted
after the event on the

Brookings Institution event Web site at http://www.brookings.edu//health/events.
    Transcripts: Please be advised that transcripts will not be
available.

SUPPLEMENTARY INFORMATION: On July 9, 2012, the President signed into
law the Food and Drug Administration Safety and Innovation Act (FDASIA)
(Pub. L. 112-144). Title I of FDASIA reauthorizes PDUFA and provides
FDA with the user fee resources necessary to maintain an efficient
review process for human drug and biological products. The
reauthorization of PDUFA includes performance goals and procedures for
the Agency that represent FDA's commitments during fiscal years 2013-
2017 (PDUFA V). These commitments are fully described in the document
entitled ``PDUFA Reauthorization Performance Goals and Procedures
Fiscal Years 2013 Through 2017'' (PDUFA Goals Letter), available on
FDA's Web site at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf. Section XI of the PDUFA Goals
Letter, entitled ``Enhancement and Modernization of the FDA Drug Safety
System,'' includes Sentinel as a tool for evaluating drug safety issues
that may require regulatory action. As part of this enhancement, FDA
committed to hold a public meeting to engage stakeholders in a
discussion of current and emerging Sentinel projects and facilitate
stakeholder feedback and input to determine the feasibility of using
Sentinel to evaluate drug safety issues that may require regulatory
action, e.g., labeling changes, PMRs, or PMCs. The public workshop
announced by this notice will fulfill this commitment.

    Dated: November 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26855 Filed 11-7-13; 8:45 am]
BILLING CODE 4160-01-P


	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

	WASHINGTON, D.C.  20460

                                                    OFFICE OF
PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

May 7, 2009

MEMORANDUM

SUBJECT:	Updated Review of Fluazinam Incident Reports

FROM:	Monica Hawkins, M.P.H., Environmental Health Scientist

		Toxicology and Epidemiology Branch

		Health Effects Division (7509P)

		Jessie Cordova, Information Technology Specialist

		Toxicology and Epidemiology Branch

		Health Effect Division (7509P)

THRU:	Mary Manibusan, Branch Chief

		Toxicology and Epidemiology Branch

		Health Effects Division (7509P)

TO:		Rosanna Louie, CRM

		Special Review and Reregistration Division (7508P)

BACKGROUND

The OPP Incident Data System (IDS) was consulted for poisoning incident
data on the active ingredient fluazinam.  The purpose of the database
search is to identify potential patterns on the extent and severity of
the health effects attributed to fluazinam exposure.  The IDS includes
reports of incidents from various sources, including mandatory Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6 (a) (2)
reports from registrants, other federal and state health and
environmental agencies and individual consumers.  The following
databases were not searched for poisoning incident data:  the American
Association of Poison Control Centers Toxic Exposure Surveillance System
(TESS), the California Pesticide Illness Surveillance Program, and the
National Institute of Occupational Safety and Health’s Sentinel Event
Notification System for Occupational Risks (NIOSH SENSOR).  The EPA is
supplying the following incident report to fulfill our requirement to
docket summaries of incident data that were reported to the Agency.
This report represents 1 incidents occurring in the United States from
2002 to the present for the single chemical only.

.

Reports of adverse health effects allegedly due to a specific pesticide
exposure (an “incident”) are largely self-reported and therefore,
generally speaking, neither exposure to a pesticide or reported symptom
(or the connection between the two) is validated.  However, incident
information can be an important feedback loop to the Agency –
incidents of severe outcome, or a suggested pattern or trend among less
severe incidents can signal the Agency to further investigate a
particular chemical or product.

The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section
6(a)(2) includes reports of alleged human health incidents from various
sources, including mandatory reports from registrants, other federal and
state health and environmental agencies and individual consumers.  Since
1992, OPP compiles these reports in an Incident Data System (IDS).
Reports submitted to the IDS represent anecdotal reports or allegations
only, unless otherwise stated in this report.  Typically, OPP does not
draw firm conclusions implicating the pesticide is causally associated
with the reported health effects.  Nevertheless, in some instances if
enough cases and/or documentation of exposure and health effect or
suggested patterns of exposure and response are indicative of a strong
relationship, risk mitigation measures may be suggested.

The evaluation of incident data for fluazinam chemicals has reported
(relatively low volume of incident , no moderate or severe health
effects that are plausibly related to the pesticide in question, based
on toxicological data, sporadic incidents of an undefined or
non-specific nature such as that clear trends or patterns cannot be
discerned) only 1number of incidents, symptoms appear generic and not
confirmed to be related to exposure, there is no clear evidence of a
trend or exposure pattern. Therefore, at this time, there are no
remarkable case reports which suggest a plausible association between a
moderate or severe health outcome and exposure to pesticide fluazinam
nor can we discern any suggestion of a trend or pattern regarding the
health effects due to the alleged exposure to pesticide fluazinam.  The
current review of the incident data does not warrant further
investigations at this time.

IDS Report

5/7/2009

	Chemical: Fluazinam

129098	Human Incidents

Incident Number	Incident Date	Product Name	Registration Number	City
State	Exposure Type*	Incident Description

015485	006	25-Aug-04	OMEGA 50 DF<PHONE_NUMBER>1 000100	LA GRANDE	OR	HC
Unknown Adult (18-64 years old) Male was exposed to the product at work.
He poured it into a big mixer and then injected it into potatoes. The
man wears rubber gloves and protective clothing. He has had an
intermittent Rash during the past 3 weeks.