[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Notices]
[Pages 20070-20071]
[FR Doc No: 2018-09650]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2018-0192; FRL-9976-55]

Dinotefuran; Receipt of Applications for Emergency Exemptions,
Solicitation of Public Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received specific exemption requests from the Delaware
Department of Agriculture (DDA), the Maryland Department of Agriculture
(MDA), the Pennsylvania Department of Agriculture (PDA) and the
Virginia Department of Agriculture and Consumer Services (VDACS) to use
the insecticide dinotefuran (CAS No. 165252-70-0) to treat up to 58,118
acres of pome and stone fruits to control the brown marmorated
stinkbug. The applicants propose uses which are supported by the
Interregional Research Project Number 4 (IR-4) and have been requested
in 5 or more previous years, and petitions for tolerances have not yet
been submitted to the Agency. Therefore, EPA is soliciting public
comment before making the decision whether to grant the exemptions.

DATES: Comments must be received on or before May 22, 2018.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2018-0192, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).

     Pesticide manufacturing (NAICS code 32532).

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
www.regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the
pesticide(s) discussed in this document, compared to the general
population.

II. What action is the agency taking?

    Under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136p), at the discretion of the EPA
Administrator, a Federal or State agency may be exempted from any
provision of FIFRA if the EPA Administrator determines that emergency
conditions exist which require the exemption. The DDA, MDA, PDA and
VDACS have requested the EPA Administrator to issue specific exemptions
for the use of dinotefuran on pome and stone fruits to control the
brown marmorated stinkbug. Information in accordance with 40 CFR part
166 was submitted as part of the requests.
    As part of the requests, the applicants assert that the rapid
spread of large outbreaks of the brown marmorated stinkbug (a recent
invasive species) resulted in an urgent and non-routine pest control
situation that is expected to cause significant economic losses without
the requested uses. The Applicants propose to make no more than two
applications at a rate of 0.203 to 0.304 lb. (maximum of 0.608 lb.) of
dinotefuran per acre, on up to 58,118 acres of pome and stone fruit
grown in Delaware, Maryland, Pennsylvania and Virginia from April 1 to
October 15, 2018. A total of 35,335 lbs. of dinotefuran could be used
(maximum acreage at highest rate).
    This notice does not constitute a decision by EPA on the
applications themselves. The regulations governing FIFRA section 18 at
40 CFR 166.24(7), require publication of a notice of receipt of an
application for a specific exemption proposing a use which is supported
by the Interregional Research Project Number 4 (IR-4) and has been
requested in 5 or more previous years, and a petition for tolerance has
not yet been submitted to the Agency. The notice provides an
opportunity for public comment on the application. The Agency, will
review and consider all comments received during the comment period in
determining whether to issue the specific exemptions requested by the
DDA, MDA, PDA and VDACS.

    Authority: 7 U.S.C. 136 et seq.

    Dated: April 17, 2018.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2018-09650 Filed 5-4-18; 8:45 am]
 BILLING CODE 6560-50-P


Information Collection Request for:

2003 Report to Congress on Impacts and Control of Combined Sewer Overflows and Sanitary Sewer Overflows ICR Number: 2063.01 Prepared by: Limno Tech, Inc. Prepared for: Water Permits Division, Office of Wastewater Management Date Submitted: June 18, 2002 Table of Contents 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title Of The Information Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1( b) Short Characterization/ Abstract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2. NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 2( b) Practical Utility/ Users of the Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3. NONDUPLICATION, CONSULTATION, AND OTHER COLLECTION CRITERIA 3( a) Nonduplication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3( b) Public Notice Required Prior to ICR Submission to OMB . . . . . . . . . . . . . . . . . . . . 3 3( c) Consultations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( d) Effects Of Less Frequent Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 3( e) General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 3( f) Confidentiality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 3( g) Sensitive Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents/ SIC Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4( b) Information Requested . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 ( i) Data items, including recordkeeping requirements . . . . . . . . . . . . . . . . . . . . . 5 ( ii) Respondent Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Telephone Interviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 File Reviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Site Visits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 5. THE INFORMATION COLLECTED  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 5( b) Collection Methodology and Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 5( c) Small Entity Flexibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 5( d) Collection Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 State Collection Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Municipalities Collection Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 6( a) Estimating the Respondent Burden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 6( b) Estimating Respondent Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 ( i) Estimating Labor Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Table 6 1: State Burden Hours and Costs . . . . . . . . . . . . . . . . . . . . . . . . 9 Table 6 2: Municipal Burden Hours and Costs . . . . . . . . . . . . . . . . . . . . 9 ( ii) Estimating Capital and Operations and Maintenance Costs . . . . . . . . . . . . . 10 6( c) Estimating Agency Burden and Cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Table 6 3: Agency Burden Hours And Costs . . . . . . . . . . . . . . . . . . . . . . . . . . 10 6( d) Estimating the Respondent Universe and Total Burden and Costs . . . . . . . . . . . . . 11 6( e) Bottom Line Burden Hours and Cost Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 ( i) Respondent Tally . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Table 6 4: Total Respondent Burden . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 ( ii) Agency Tally . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Table 6 5: Total Estimated Federal Burden . . . . . . . . . . . . . . . . . . . . . . 11 6( f) Reasons For Change in Burden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 6( g) Burden Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Page 1 of 12 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title Of The Information Collection 2003 Report to Congress on Impacts and Control of Combined Sewer Overflows and Sanitary Sewer Overflows 1( b) Short Characterization/ Abstract The 2003 Report to Congress on Impacts and Control of Combined Sewer Overflows and Sanitary Sewer Overflows is being developed to meet a requirement included in the Consolidated Appropriations Act for Fiscal Year 2001, P. L. 106 554. The U. S. Environmental Protection Agency ( EPA) Office of Wastewater Management ( OWM) will use data from federal sources, state environmental agencies, state and local health departments, and municipalities to determine, summarize, and report the extent of human health and environmental impacts caused by municipal combined sewer overflows ( CSOs) and sanitary sewer overflows ( SSOs). This Report will also include information on resources spent to address these impacts and an evaluation of the technologies used by municipalities to address these impacts. In addition, this Report will support EPA's SSO Notice of Proposed Rulemaking effort and data integration efforts for the National Pollutant Discharge Elimination System ( NPDES) program.

OWM's method for collecting and analyzing the data for CSOs and SSOs from state environmental agencies, state and local health departments, and municipalities is as follows:

° Site visits ° Interviews ° File review ° Phone calls to a subset of publicly owned treatment works ( POTWs) and health departments nationwide The data collected and analyzed for this Report will include the frequency, cause, and location of permitted and unpermitted wastewater discharges, the volume of pollutants discharged, and the constituents discharged; environmental and public health impacts of discharges; the resources spent to address these impacts; and an evaluation of the technologies used to address these impacts.

All data will be stored in a data management system developed by OWM. The data will be used as a cornerstone of the 2003 Report to Congress, giving federal offices, states, municipalities, and the public full access to the data collected both in print and through OWM's website.

The burden for EPA, states, and municipalities to provide, analyze, and review data submitted is a total of 8,245 hours and a cost of $ 1,331,233. This burden will occur once, and the collection of information should be completed one year from the effective date of the ICR. Of the total Page 2 of 12 portion, the municipal burden is 2,565 hours and $ 121,986. The states burden is 3,735 hours and $ 185,506. The federal government burden is 1,945 hours and $ 1,023,741. Included in the total federal labor cost is contractor support. Contractor support is not included in the federal burden hours. A detailed cost breakdown of federal, state, and municipal burden, including agency and respondent activities, is included in this ICR ( Sections 6b, Part i and 6c).

2. NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection OWM needs to obtain data from states and municipalities regarding the human health and environmental impacts from CSOs and SSOs as well as the technologies used to prevent such impacts. As required by the Consolidated Appropriations Act for Fiscal Year 2001, P. L. 106 554, EPA is producing this Report to be submitted to Congress no later than December 15, 2003.

Through the data collection and analysis, EPA, with the assistance of a contractor, will summarize and report on the location of discharges causing such impacts, the volume of pollutants discharged, and the constituents discharged; the resources spent to address these impacts; and the technologies used by municipalities to address these impacts. In addition, this Report will aid OWM's goal of developing better data to support the implementation of the NPDES program.

2( b) Practical Utility/ Users of the Data Information collected during this effort will be used by EPA, states, municipalities, and the general public. EPA program offices will use the data to characterize the extent of human health and environmental impacts caused by sewer overflows, the resources spent to address these impacts, and to evaluate technologies used to control these overflows. EPA program offices will use the data as an indicator of program performance at state and regional levels. States and municipalities will be able to obtain information on current technologies and costs associated with controlling CSOs and SSOs and view efforts being made around the country. The public can use the data to become more knowledgeable about the challenges their communities are facing in controlling sewer overflows and the steps taken to control overflow events.

3. NONDUPLICATION, CONSULTATION, AND OTHER COLLECTION CRITERIA 3( a) Nonduplication The information requested from the respondents is necessary to respond to Congress and is not available from other sources. In order to make this determination, EPA reviewed the existing ICR for the CSO program and found that it did not cover the types of information requested by Congress in P. L. 106 554. There is no current ICR for the collection of information related to SSOs. EPA has also made every reasonable attempt to ensure that the data and information is not currently available through less burdensome mechanisms. Page 3 of 12 3( b) Public Notice Required Prior to ICR Submission to OMB The first notice for the 2003 Report to Congress on Impacts and Control of Combined Sewer Overflows and Sanitary Sewer Overflows data collection was published on May 2, 2002, in Federal Register 67 pages 22077 22078 ( see attached). In this notice, a 60 day public comment period was solicited.

A second notice will be published in the Federal Register no sooner than July 1, 2002. A 30 day public comment period will be solicited in the second notice.

3( c) Consultations EPA conducted meetings with representatives of several organizations knowledgeable about the issues being explored in the 2003 Report to Congress. The Association of Metropolitan Sewerage Agencies ( AMSA), Water Environment Foundation ( WEF), Natural Resources Defense Council ( NRDC), and CSO Partnership have all made substantial contributions to the focus and scope of this project. Meetings with these organizations have contributed to EPA's determination that the necessary data does exist, and assisted in developing the methodology that will be used to collect this information. Contact persons from the organizations mentioned are as follows:

AMSA Greg Schaner, Manager of Government Affairs 1816 Jefferson Place, NW Washington, DC 20036 Phone: ( 202) 296 9836; Fax: ( 202) 833 4657 WEF Nancy Wheatley, Government Affairs Committee Chair George Martin, Collection Systems Committee Chair 601 Wythe Street Alexandria, VA 22314 Phone: ( 703) 684 2400; Fax: ( 703) 684 2492 NRDC Nancy Stoner, Senior Attorney 1200 New York Avenue, NW Suite 400 Washington, DC 20005 Phone: ( 202) 289 2394; Fax ( 202) 289 1060 Page 4 of 12 CSO Partnership Mark Poland P. O. Box 51 Richmond, VA 23218 Phone: ( 804) 775 7736 Other organizations will be invited to submit comments via publication of notices in the Federal Register.

3( d) Effects Of Less Frequent Collection EPA is requesting the information only once during the data collection period effort to support the development of the Report.

3( e) General Guidelines Data collection for the 2003 Report to Congress on Impacts and Control of Combined Sewer Overflows and Sanitary Sewer Overflows will be in accordance to Paperwork Reduction Act ( 5 CFR 1320.5 ( d)( 2)) and adhere to OMB guidelines for data collection.

3( f) Confidentiality Measures to ensure confidentiality of the data collected ( including human health and environmental impacts, locations of discharges, volume of pollutants discharged, and resources spent) are unnecessary. The information submitted voluntarily by regional, state, and municipal respondents is public information.

3( g) Sensitive Questions Respondents will not be subjected to any sensitive questions ( i. e., race, sex, and/ or religion) as a result of this ICR.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents/ SIC Codes Private industries will not be contacted to obtain data for the Report; therefore, SIC codes will not be needed. All information will be provided voluntarily by states and municipalities. Page 5 of 12 4( b) Information Requested ( i) Data items, including recordkeeping requirements EPA plans to collect data from state environmental agencies, state and local health departments, and municipalities to support the development of the 2003 Report to Congress. Entities will be requested to report previously collected public data on:

° Frequency, cause, and locations of sewer overflows ° Volume and constituents of pollutants discharged ° Resources spent to address impacts ° Technologies used to address impacts ° Documented human health and environmental impacts from sewer overflows The data being requested may be found in documents which are over three years old, yet all information is expected to be readily available, if previously collected.

No recordkeeping items will be requested for this Report.

( ii) Respondent Activities The state and municipal role in assisting this effort will request them to participate in the following:

° Telephone interviews ° File reviews ° Site visits All information that is being requested is voluntary. Details of their involvement is summarized below.

1) Telephone Interviews A contractor will contact selected agencies and request to schedule a telephone interview. Interviews typically last from five to thirty minutes. During this time, the respondent may be asked to provide certain documents or additional information at a later date. Information being requested is readily available and requires a minimal effort on the part of the respondent. After the interview, the respondent may be asked to review or verify a summary of the data collected.

2) File Reviews A team of contractors will visit selected states and municipalities nationwide to gather information requiring a more extensive amount of research or study than possible during a phone interview. The respondent would be asked to arrange access to the documents of interest and assist with any questions that might arise. A minimal amount of effort is required on the part of the respondent. After the review, the respondent may be asked to review or verify an abbreviated summary of the Page 6 of 12 data collected.

3) Site Visits A general site visit will consist of several interviews/ discussions between EPA staff, a contractor team, and selected respondents at the site as well as file reviews. The interviews are longer than a telephone interview, possibly lasting several hours, and file reviews will be the same as described above. A time commitment of several hours may be required by one or more of the respondents. After the interview, a designated contact may be asked to review or verify a summary of the data collected.

5. THE INFORMATION COLLECTED  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities EPA will develop the 2003 Report to Congress on Impacts and Control of Combined Sewer Overflows and Sanitary Sewer Overflows based on the data obtained from states and municipalities. As part of this effort, EPA will undertake the following activities:

° Set up a data management system ° Answer respondent questions ° Compile and analyze data ° Reformat and distribute the data ° Store the data 5( b) Collection Methodology and Management OWM plans to collect data from state environmental agencies, state and local health departments, and municipalities to support the development of this Report. Information collection activities will include: telephone interviews, file review, and site visits, as well as telephone calls to a sample of POTWs and health departments nationwide. Responses to the collection of information is voluntary.

OWM will develop a master data management system populated with information collected from telephone interviews, file reviews, and site visits to selected entities. Information from interviews and file reviews will be initially recorded on paper and stored in files for each state. The data will then be entered and checked for quality assurance by contractor staff, which includes reviewing original documents for clarity and consistency and developing automated database queries to expose inconsistent/ questionable data. A crucial step of the QA/ QC process includes providing data summaries to the state or municipality from which information was collected for review and comment. The data management system will be maintained in Microsoft ACCESS, but selections will be queried and re formatted as necessary for each state's review. Once the 2003 Report to Congress is published, a queriable version of the data management system will be posted on Page 7 of 12 OWM's website ( www. epa. gov/ npdes) for public access.

5( c) Small Entity Flexibility In an effort to minimize the data that will need to be collected from small entities, EPA is requesting that states provide any information that has already been entered into a data management system or can be reviewed during contractor site visits. EPA will also provide contractor support to small entities in compiling and analyzing any data.

5( d) Collection Schedule The collection schedule for the 2003 Report to Congress on Impacts and Control of Combined Sewer Overflows and Sanitary Sewer Overflows will be from May 2002 through one year from the effective date of this ICR. During this time, EPA and its contractor will conduct site visits to states and municipalities as well as meetings of experts and stakeholders. Throughout the data collection, the contractor will utilize EPA, state, and municipal officials to review the information written for this Report including case studies. Following is an in depth collection schedule for this Report:

State Collection Schedule Beginning in May 2002 and concluding one year from the effective date of this ICR, state site visits will be conducted. Each site visit will be approximately three days in length. Permit information from the state's will be collected during the site visits as well as any existing reports or studies detailing the occurrence of CSOs and SSOs and their impacts.

Municipalities Collection Schedule To collect data from municipalities for the Report, site visits will be conducted beginning in May 2002 and are scheduled to be completed one year from the effective date of this ICR. Each municipal site visit will be approximately two days in length. Municipal data collection will also include interviews with local health department officials that have collected data related to the human health impacts that are attributable to SSOs and CSOs.

The data collection on the resources municipalities have spent and available plans for future spending will also be completed one year from the effective date of this ICR. During the telephone interviews and site visits with states and municipalities, the contractor will collect information on the resources involved in controlling CSOs and SSOs. The data collection will seek only information on resources spent or documented plans for future expenditure.

The collected data will be presented in the 2003 Report to Congress on Impacts and Control of Combined Sewer Overflows and Sanitary Sewer Overflows. The public will have access to the Report after it has been delivered to Congress. In addition, this Report will also be accessible via the Internet at www. epa. gov/ npdes in the winter/ spring of 2004. Page 8 of 12 6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 6( a) Estimating the Respondent Burden The estimated respondent burden associated with documenting the impacts of sewer overflows has been itemized into the following categories: federal, state, and municipal.

The total estimated burden for the information collection is 6,300 hours and a total labor cost of $ 307,492. This cost will only be incurred once by all entities and information obtained will be reported by December 15, 2003. The total burden for municipalities is 2,565 hours and $ 121,986. State burden is 3,725 hours and $ 185,506. Agency burden is 1,945 hours and $ 1,023,741. The federal labor costs associated with this Report includes substantial contractor support. Contractor burden hours are not included in this ICR.

Municipal burden include telephone interviews and site visits to collect data on the human health and environmental impacts associated with CSOs and SSOs, along with information related to cost and effectiveness of various controls technologies. Burden incurred by state governments and the Agency also includes telephone interviews and site visits with officials to support the data collection effort, and time spent reviewing draft case studies and the Report sections prepared by contractor.

Burden hour estimates are based on trends observed during previous meetings and file reviews that EPA has conducted for similar reports. States and municipalities will be asked to participate in interviews, facilitate file review by a contractor team, and review summary documents. The agency estimates that a state or municipal representative would spend an average of two to ten hours in meetings/ interviews, one to three hours facilitating on site file reviews, and approximately two hours reviewing summary documents or case studies. Tables 6 1 through Table 6 3, located on page 9 and 10 of this ICR, provide a complete breakdown of burden hours and costs estimates for the states, municipalities and the Agency.

6( b) Estimating Respondent Costs The total labor cost to collect and provide information for the 2003 Report to Congress on Impacts and Control of Combined Sewer Overflows and Sanitary Sewer Overflows over one year is $ 307,492.

( i) Estimating Labor Costs To develop estimated labor costs, EPA used information from the Bureau of Labor Statistics on the average annual salaries for state and municipal personnel involved in " air, water or waste management." The annual salaries were divided by 2,080 hours to obtain an average hourly wage. An overhead rate of 1.6% was applied to both managerial and administrative salaries to obtain loaded hourly rates. Page 9 of 12 Hours and Costs Per Respondent Total State Hours and Cost Technical Hours Clerical Hours Respondent Hours Per Year Labor Cost Per Year Number of Respondent Total Hours Per Year Total Cost Per Year INFORMATION COLLECTION ACTIVITY 54.52 $ 37.58 $

History & Background on Issues Related to the Control of CSOs and SSOs 4.0 0.0 4.0 218.08 $ 10 40.0 2,180.80 $ Characterization of the SSO Problem 25.0 14.0 39.0 1,889.12 $ 75 2,925 141,684.00 $ Characterization of the CSO Problem 1.0 0.0 1.0 54.52 $ 100 100.0 5,452.00 $ Evaluation of Human Health Impacts Attributable to SSOs and CSOs 8.0 0.0 8.0 436.16 $ 20 160.0 8,723.20 $ Evaluation of Environmental Impact Attributable to SSOs and CSOs 8.0 0.0 8.0 436.16 $ 20 160.0 8,723.20 $ Evaluation of Actions to Control CSOs 4.0 1.0 5.0 255.66 $ 10 50.0 2,556.60 $ Assessment of Resources Spent and Planned for CSO Control 8.0 0.0 8.0 436.16 $ 10 80.0 4,361.60 $ Evaluation of Actions to Control SSOs 4.0 1.0 5.0 255.66 $ 10 50.0 2,556.60 $ Assessment of Resources Spent and Planned for SSO Control 8.0 0.0 8.0 436.16 $ 20 160.0 8,723.20 $ Assessment of Benefits for Wet Weather Control Technologies 2.0 0.0 2.0 109.04 $ 5 10.0 545.20 $

SUBTOTAL Varies Varies Varies 4,526.72 $ 280 3,735 185,506.40 $

Hours and Costs Per Respondent Total Municipal Hours and Cost Technical Hours Clerical Hours Respondent Hours Per Year Labor Cost Per Year Number of Respondent Total Hours Per Year Total Cost Per Year INFORMATION COLLECTION ACTIVITY 50.95 $ 35.13 $

History & Background on Issues Related to the Control of CSOs and SSOs 2.0 0.0 2.0 101.90 $ 10 20.0 1,019.00 $ Characterization of the SSO Problem 9.0 6.0 15.0 669.33 $ 50 750.0 33,466.50 $ Characterization of the CSO Problem 8.0 2.0 10.0 477.86 $ 100 1,000 47,786.00 $ Evaluation of Human Health Impacts Attributable to SSOs and CSOs 8.0 0.0 8.0 407.60 $ 20 160.0 8,152.00 $ Evaluation of Environmental Impact Attributable to SSOs and CSOs 8.0 0.0 8.0 407.60 $ 20 160.0 8,152.00 $ Evaluation of Actions to Control CSOs 8.0 2.0 10.0 477.86 $ 10 100.0 4,778.60 $ Assessment of Resources Spent and Planned for CSO Control 8.0 0.0 8.0 407.60 $ 10 80.0 4,076.00 $ Evaluation of Actions to Control SSOs 8.0 2.0 10.0 477.86 $ 10 100.0 4,778.60 $ Assessment of Resources Spent and Planned for SSO Control 8.0 0.0 8.0 407.60 $ 20 160.0 8,152.00 $ Assessment of Benefits for Wet Weather Control Technologies 5.0 2.0 7.0 325.01 $ 5 35.0 1,625.05 $

SUBTOTAL Varies Varies Varies 4,160.22 $ 255 2,565 121,985.75 $ Tables 6 1 and 6 2 show the total labor hours and costs associated with administrative and management burden for states and municipalities in gathering CSO and SSO information for the one time collection.

TABLE 6 1: STATE BURDEN HOURS AND COSTS TABLE 6 2: MUNICIPAL BURDEN HOURS AND COSTS Page 10 of 12 Hours and Costs Per Respondent Other Costs Total Costs Technical Hours Clerical Hours Total Hours Per Year Labor Cost Per Year Contractor Cost Per Year Total Cost Per Year INFORMATION COLLECTION ACTIVITY 78.91 $ 54.41 $

History & Background on Issues Related to the Control of CSOs and SSOs 10.0 0.0 10.0 789.10 $ 16,351.40 $ 17,140.50 $ Characterization of the SSO Problem 675.0 150.0 825.0 61,425.75 $ 286,313.65 $ 347,739.40 $ Characterization of the CSO Problem 300.0 0.0 300.0 23,673.00 $ 198,497.20 $ 222,170.20 $ Evaluation of Human Health Impacts Attributable to SSOs and CSOs 255.0 112.5 337.5 26,243.18 $ 79,315.20 $ 105,558.38 $ Evaluation of Environmental Impact Attributable to SSOs and CSOs 180.0 90.0 270.0 19,100.70 $ 69,046.00 $ 88,146.70 $ Evaluation of Actions to Control CSOs 40.0 40.0 80.0 5,332.80 $ 54,802.80 $ 60,135.60 $ Assessment of Resources Spent and Planned for CSO Control 10.0 5.0 15.0 1,061.15 $ 25,305.80 $ 26,366.95 $ Evaluation of Actions to Control SSOs 40.0 40.0 80.0 5,332.80 $ 82,201.60 $ 87,534.40 $ Assessment of Resources Spent and Planned for SSO Control 5.0 2.5 7.5 530.58 $ 41,849.60 $ 42,380.18 $ Assessment of Benefits for Wet Weather Control Technologies 20.0 0.0 20.0 1,578.20 $ 24,990.80 $ 26,569.00 $

SUBTOTAL Varies Varies Varies 145,067.25 $ 878,674.05 $ 1,023,741.30 $ ( ii) Estimating Capital and Operations and Maintenance Costs Non labor costs are not associated with this data collection; therefore, EPA estimates that operations and maintenance costs for this ICR to be zero.

6( c) Estimating Agency Burden and Cost The development of the Report will require EPA to devote time and resources to data collection and the review of materials prepared by the contractor. The total estimated Agency burden for this effort is 1,945 hours and labor cost is $ 1,023,741. The Agency labor cost associated with this Report includes substantial contractor support. Contractor burden hours are not included in this ICR.

To develop labor costs, EPA multiplied the number of hours that will be required to assist in the compilation and collection of data by specific GS rates to generate a cost estimate. Since labor rates vary, EPA used an average hourly rate of $ 30.35 ( GS 12, step 5) for managerial and an average hourly rate of $ 20.93 ( GS 9, step 5) for administrative staff. Cost estimates for the Agency were based on the GS pay level for 2001. An overhead rate of 1.6% was applied to both the managerial and administrative salaries to obtain loaded rates of $ 78.91 and $ 54.41 respectively.

Table 6 3 provides a description of the various activities the Agency is expected to perform as part of the data collection. The table includes the Agency's hours and labor cost per activity.

TABLE 6 3: AGENCY BURDEN HOURS AND COSTS Page 11 of 12 6( d) Estimating the Respondent Universe and Total Burden and Costs EPA estimates that 535 respondents will be needed nationwide to collect the necessary data to develop the 2003 Report to Congress. This estimate includes 280 state respondents and 255 municipal respondents. EPA expects that the total burden to states will be 3,735 hours and total labor cost is $ 185,506. Further, EPA expects that the total burden to municipalities will be 2,565 hours at a labor cost of $ 121,986.

6( e) Bottom Line Burden Hours and Cost Tables ( i) Respondent Tally Respondent labor hours will vary according to task; however, EPA is relying on each respondent to support the data collection gathering both administratively and managerially as outlined in Table 6 4. In summary, the breakdown of the state and municipal total labor hours, which is 6,300 is as follows: 3,735 for states and 2,565 for municipalities. The estimated total labor cost for states and municipalities is $ 307,492 with states incurring $ 185,506 and municipalities incurring $ 121,986.

TABLE 6 4: TOTAL RESPONDENT BURDEN Number of Respondents Total Hours Per Year Total Labor Cost Per Year State 280 3,735 $ 185,506.40 Municipal 255 2,565 $ 121,985.75 TOTAL 535 6,300 $ 307,492.15 ( ii) Agency Tally The total administrative and managerial labor burden that the Agency will incur is 1,945. The estimated total Agency labor cost is $ 1,023,741. Included in the total labor cost is contractor support. Contractor support is not included in the Agency burden hours. The total Agency burden is summarized in Table 6 5.

TABLE 6 5: TOTAL ESTIMATED AGENCY BURDEN Total Agency Hours Per Year Total Agency Labor Cost Per Year Total Contractor Labor Cost Per Year Total Labor Cost To Agency Per Year TOTAL 1,945 $ 145,067.25 $ 878,674.05 $ 1,023,741.30 Page 12 of 12 6( f) Reasons For Change in Burden There is no reason for change in burden at this time.

6( g) Burden Statement The total cost for EPA to obtain data for the 2003 Report to Congress on Impacts and Control of Combined Sewer Overflows and Sanitary Sewer Overflows is estimated to be 6,300 labor hours and an estimated cost is $ 307,492. The estimate includes labor costs to the state and municipalities. The states and municipalities should not incur any operations and maintenance costs for the data being requested. 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.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822T), 1200 Pennsylvania Avenue, NW, Washington, D. C. 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D. C. 20503, Attention: Desk Officer for EPA. Include the EPA ICR number 2063.01 in any correspondence.


2 1 September 19, 2005 CHAPTER TWO METHODOLOGY For the proposed Phase 2 burden reduction rule, EPA must estimate the burden and cost savings, as well as other impacts associated with the options considered. This chapter presents the methodologies used to estimate: 1) the unit time and cost savings experienced by TRI reporters as a result of the proposed rule, 2) the number of facilities and forms that would be able to take advantage of each option separately and combined, and 3) the impacts on small entities. Total reporting burden and cost savings are presented in Chapter Three. The benefits of the proposed rule are discussed in Chapter Four. The impacts of the proposed rule on reporting are discussed in Chapter 5 As explained in more detail in Chapter One, EPA is proposing two options that it believes may reduce reporting burden for TRI facilities. The New Eligibility for Form A: PBT Chemicals Option allows a facility reporting on PBT chemicals ( except for dioxin and dioxin like compounds) with no disposal or other releases to use Form A, provided they meet the 1,000,000 pound alternate reporting threshold and have no more than 500 pounds in Sections 8.2 through 8.8 and do not include any releases or disposal in their Section 8.8 quantities. The Expanded Eligibility for Form A: Non PBT Chemicals Option extends the existing Form A eligibility criteria and allows a facility reporting on Non PBT chemicals with an annual reportable amount ( sections 8.1   8.7) of 5,000 lbs or less to use Form A, provided they meet the 1,000,000 pound alternate reporting threshold.

Some facilities may qualify for both options, however, for different chemicals. Although these options could be proposed separately, EPA is combining the options in the proposed rule.

Industry burden and cost savings were calculated using the following four step procedure:

Step 1: Estimate the typical total number of hours of managerial, technical, and clerical labor needed to complete each task for each type of form.

Step 2: Calculate the hours saved by each labor category for each task due to filing a less burdensome form. Based on typical labor rates, calculate the average unit savings in the first year of compliance as staff becomes familiar with the regulations and in subsequent years, when less time is needed because staff is more familiar with the regulations.

Step 3: Estimate the universe of affected forms and facilities that would qualify for each of the burden reduction options.

Step 4: For each task, multiply the unit savings by the number of facilities and/ or forms, and then sum the results to calculate the total industry savings. 2 2 September 19, 2005 2.1 UNIT BURDEN SAVINGS ESTIMATES The proposed rule will result in burden savings by reducing reporting requirements for forms that meet certain criteria. The tasks associated with TRI reporting under the proposed rule include:

Report Completion: Facilities must gather data and perform calculations to provide the information required on Form R or Form A.

Mailing and Recordkeeping: Facilities must maintain recordkeeping systems and mail their reports to EPA and the State.

To estimate the burden savings, EPA calculated the unit burden savings as the difference between the facility's current activity ( i. e., filing a Form R) and the post regulation activity ( i. e., filing a Form A).

2.1.1 Form R and Form A Unit Burden Estimates The current burden estimates for form completion estimates, which are approved by the Office of Management and Budget ( OMB), reflect the total time required by facilities to complete either a Form R or a Form A. The OMB approved reporting burden estimates are presented in Table 2 1. The estimate of total burden savings due to the proposed rule is developed by combining the estimated unit burden savings under each option with the number of potentially affected forms under each option. Unit burden savings are calculated by subtracting the unit reporting burden associated with filling out a Form A from the unit reporting burden associated with filing a Form R. In the analysis associated with the New Eligibility for Form A: PBT Chemicals Option, Form A calculations and report completion burden is assumed to be 17.6 hours for non PBT chemicals and 31.6 hours for PBT chemicals. The 17.6 hours is based on the current OMB approved burden estimate. Since there is no approved estimate for using Form A for PBT chemicals, the 17.6 hours was adjusted proportionately to the difference between the OMB approved burden estimates for Form R calculations and report completion for non PBT chemical and PBT chemicals ( i. e., 25.2 hours and 47.1 hours respectively). This resulted in a 64% adjustment of the current 17.6 hours for Form A for non PBT chemicals to 31.6 hours for Form A for PBT chemicals.

2.1.2 Hourly Labor Rate Estimate Each cost savings estimate has two components: the unit time savings estimates ( i. e., number of labor hours saved by each type of personnel), and the hourly wage rate of each level of personnel. There are three categories of hourly wage rates: managerial, technical, and clerical. EPA developed updated 2004 hourly wage rates, including fringe benefits and overhead, for each of these categories. Average wage data for these categories were taken from the Employer Costs for Employee Compensation ( ECEC) report by the Bureau of Labor Statistics ( BLS) for all goods producing, private industries. 3 The managerial labor rate is defined as the average hourly 3 Employer Costs for Employee Compensation, Private industry workers, Goods producing industries, white collar occupations, as published by the U. S. Department of Labor, Bureau of Labor Statistics. The December 2004 values for these series are listed in Table 11 of the Employer Costs for Employee Compensation Summary, released March 16, 2005. 2 3 September 19, 2005 wages and salaries for the " Management, business, and financial" occupational category. The technical labor rate is defined as the average hourly wages and salaries for the " Professional and related" occupational category. The clerical labor rate is defined as the average hourly wages and salaries for the " Office and administrative support" occupational category.

The additional cost of benefits, such as paid leave and insurance, is also derived from the ECEC data. Loading factors for benefits are calculated separately for managerial, technical, and clerical labor by dividing the benefits percentage of total compensation by the wage percentage of total compensation ( e. g., 0.29/ 0.71 = 0.4085).

An additional loading factor of 17 percent is applied for general overhead. This loading factor is added to the benefits loading factor, then applied to the base wage ( e. g., $ 33.61/ hr x [ 1 + ( 0.4085 + 0.17)] = $ 53.05/ hr). The total loading for indirect costs is within the range of 50 to 70 percent suggested in EPA guidance. 4 The results of this method are shown in Table 2 2.

4 U. S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth Edition, EPA 452 02 001, January 2002, pg. 2 34. 2 4 September 19, 2005 TABLE 2 1 OMB APPROVED FORM R AND FORM A UNIT BURDEN ESTIMATES Unit Time Estimates ( hours) ( per form)

Activity Managerial Technical Clerical Total Time Form R Subsequent Years Calculations and Report Completion  PBT Chemicals 14.3 30.8 2 47.1 Calculations and Report Completion  Non PBT Chemicals 7.7 16.4 1.1 25.2 Recordkeeping/ Submission 0 4 1 5 Form A Subsequent Years Calculations and Report Completion  PBT Chemicals 11.2 18.9 1.5 31.6 Recordkeeping/ Submission   PBT Chemicals 0 2.4 0.6 3 Calculations and Report Completion   Non PBT Chemicals 6.05 10.7 0.85 17.6 Recordkeeping/ Submission   Non PBT Chemicals 0 2.4 0.6 3 Note: Due to rounding, the total may not equal the sum of the row.

Source: Rice, Cody. Memo: Terms of Clearance for TRI ICR Renewal. Jan 20, 2004.

EPA, 2000 Form A Information Collection Request. 2 5 September 19, 2005 TABLE 2 2 DERIVATION OF LOADED HOURLY RATES FOR TRI FORM COMPLETION Labor Category 2004 Average Wages 2004 Benefits and Overhead Loading Factor 2004 Loaded Hourly Rate Managerial $ 33.61 1.578 $ 53.05 Technical $ 28.52 1.571 $ 44.79 Clerical $ 14.70 1.607 $ 23.62 Source: Employer Costs for Employee Compensation ( ECEC) report by the Bureau of Labor Statistics ( BLS).

Total cost savings are presented in Chapter Three.

2.1.3 Summary of Unit Burden Savings As discussed in Section 2.1, the unit burden savings are calculated as the difference between the facility's current activity ( i. e., filing a Form R) and the post regulation activity ( i. e., filing a Form A). Because facilities are already familiar with Form A, there will be no difference between the average burden they incur in the first year of the proposed rule and all subsequent years of the rule. Furthermore, since these facilities are already reporting to TRI, they are not expected to incur any rule familiarization burden. The unit burden savings in the two options differs because the Form R and Form A form completion estimates are higher for PBT chemicals than Non PBT chemicals. Table 2 3 summarizes the unit burden savings associated with the proposed options.

TABLE 2 3 UNIT BURDEN AND COST SAVINGS FOR ACTIVITIES PERFORMED BY INDUSTRY Unit Time Estimates ( hours) ( per form) Activity Managerial Technical Clerical Total Unit Cost ( 2004 Dollars)

Average Annual Burden and Cost Savings in the First and Subsequent Years Form Completion   Non PBT Chemicals 1.7 5.7 0.3 7.6 $ 348.74 Form Completion   PBT Chemicals 3.1 11.9 0.5 15.5 $ 709.27 Recordkeeping/ Mailing 0.0 1.6 0.4 2.0 $ 81.11 Note: Because facilities are already familiar with Form A, there is no rule familiarization cost.

Due to rounding, the total may not equal the sum of the row.

2.2 ESTIMATES OF FORMS AND FACILITIES BY OPTION Because the proposed rule primarily affects facilities that are already reporting to TRI, it was possible to query the most current frozen TRI data ( RY2002 at the time of this analysis) to determine the number of forms and facilities meeting the eligibility criteria for the two proposed 2 6 September 19, 2005 options. 6 For the New Eligibility for Form A: PBT Chemicals Option, EPA estimated that 2,703 forms filed by 2,064 facilities would qualify for this option. 7 For the Expanded Eligibility for Form A: Non PBT Chemicals Option, EPA estimated that 12,201 forms filed by 6,461 facilities would qualify for this option.

Table 2 4 summarizes the number of affected facilities and forms when the options are analyzed separately and combined.

TABLE 2 4: UNIVERSE OF AFFECTED FACILITIES AND FORMS BY OPTION New Eligibility for Form A: PBT Chemicals Option Expanded Eligibility for Form A: Non PBT Chemicals Optiona Combined Options Total Number of Affected Facilities 2,064 6,461 7,958 Total Number of Affected Forms 2,703 12,201 14,904 a The number of affected non PBT forms in this analysis does not include the non PBT forms that are currently likely eligible for Form A based on an ARA of less than or equal to 500 pounds.

Note: In this analysis, all TRI data are summed at the facility chemical level.

Source: Frozen RY2002 TRI data.

Total burden savings are presented in Chapter Three.

2.3 ESTIMATION OF IMPACTS OF THE PROPOSED RULE ON REPORTING To evaluate the impacts of the proposed rule on reporting, EPA looked at both the total release pounds and total production related waste pounds on a chemical by chemical basis that would not be reported if Form As were substituted for Form Rs for chemical submissions. The EPA also conducted an analysis of zip codes affected by new and expanded Form A eligibility.

6 Note that there may be new facilities filing to TRI for the first time that may experience burden reduction due to the proposed rule. Without information on their reportable chemicals and amounts, however, it is not possible to determine the option for which they would qualify and they are thus not accounted for in this analysis.

7 Any positive values reported in Section 8.8 are assumed to be a release or disposal quantity if a positive value was also reported in Section 5, Section 6.1 when the chemical is a metal, Section 6.2 for disposal M codes, or Section 6.2 for M40 ( Solidification/ Stabilization) and M61 ( Wastewater treatment ( Excluding POTW)) when the chemical is a metal.


[Federal Register Volume 86, Number 211 (Thursday, November 4, 2021)]
[Notices]
[Pages 60834-60835]
[FR Doc No: 2021-24073]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6784]

Manufacture of Blood Components Using a Pathogen Reduction Device
in Blood Establishments: Questions and Answers; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Manufacture of Blood
Components Using a Pathogen Reduction Device in Blood Establishments:
Questions and Answers; Guidance for Industry.'' The guidance document
provides blood establishments that collect or process blood and blood
components with recommendations for implementing a pathogen reduction
device for the manufacture of pathogen-reduced blood components. The
guidance, in a question-and-answer format, addresses the most
frequently asked questions concerning implementation of the
INTERCEPT[supreg] Blood System for Platelets and Plasma. The guidance
also provides recommendations to licensed manufacturers on reporting
the manufacturing changes associated with implementation of a pathogen
reduction device. The guidance announced in this notice finalizes the
draft document entitled ``Implementation of Pathogen Reduction
Technology in the Manufacture of Blood Components in Blood
Establishments: Questions and Answers; Draft Guidance for Industry,''
dated December 2017.

DATES: The announcement of the guidance is published in the Federal
Register on November 4, 2021.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-6784 for ``Manufacture of Blood Components using a Pathogen
Reduction Device in Blood Establishments: Questions and Answers;
Guidance for Industry.'' 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, 240-
402-7500.
     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)).
    Submit written requests for single copies of the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,

Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist the office in processing your requests. The guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled
``Manufacture of Blood Components Using a Pathogen Reduction Device in
Blood Establishments: Questions and Answers; Guidance for Industry.''
The guidance document provides blood establishments that collect or
process blood and blood components with recommendations for
implementing a pathogen reduction device for the manufacture of
pathogen-reduced blood components. The guidance, in a question-and-
answer format, addresses the most frequently asked questions on this
topic. The guidance also provides recommendations to licensed
manufacturers on reporting the manufacturing changes associated with
implementation of a pathogen reduction device under 21 CFR 601.12.
    The recommendations in the guidance apply to blood establishments
that intend to manufacture pathogen-reduced platelet and plasma
products using an FDA approved pathogen reduction device. Currently,
the INTERCEPT[supreg] Blood System has been approved for the
manufacture of certain pathogen-reduced platelet and plasma products.
If the product platforms for this FDA approved device change, or FDA
approves another pathogen reduction device with a similar intended use
in the future, the Agency will consider providing additional
recommendations to blood establishments.
    In the Federal Register of December 27, 2017 (82 FR 61304), FDA
announced the availability of the draft document entitled
``Implementation of Pathogen Reduction Technology in the Manufacture of
Blood Components in Blood Establishments: Questions and Answers; Draft
Guidance for Industry.'' FDA received a few comments on the draft
guidance. The comments addressed various issues, including the
indications for use of the INTERCEPT[supreg] Blood System for Platelets
and Plasma; sampling plans for quality control and validation of the
manufacturing process in blood establishments; labeling of pathogen
reduced blood components; submissions to FDA for changes to an approved
application; and requirements for licensure of pathogen reduced blood
components. One comment raised a concern that the guidance addresses a
single product. FDA made changes to the guidance to reflect revised
labeling for the INTERCEPT[supreg] Blood System, and to improve clarity
of the recommendations, including those related to quality control and
submissions to FDA. Additionally, FDA changed the title of the guidance
to clarify that the purpose of the guidance is to provide
recommendations for implementing a pathogen reduction device in blood
establishments, as opposed to providing recommendations regarding the
clinical use of products. However, FDA did not make substantive changes
to the guidance in response to the public comments. The guidance
announced in this notice finalizes the draft guidance dated December
2017.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on the manufacture of blood components using a
pathogen reduction device in blood establishments. 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

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338; the collections of information in 21 CFR
parts 606 and 630 have been approved under OMB control number 0910-
0116.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 29, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24073 Filed 11-3-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 192 (Thursday, October 3, 2019)]
[Notices]
[Pages 52881-52882]
[FR Doc No: 2019-21494]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP19-19-000]

Magnolia LNG, LLC; Notice of Availability of the Draft
Environmental Impact Statement for the Proposed Magnolia LNG Production
Capacity Amendment

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared a draft supplemental environmental impact
statement (EIS) for the Production Capacity Amendment, proposed by
Magnolia LNG, LLC (Magnolia LNG) in the above-referenced docket.
Magnolia LNG requests authorization to increase the liquefied natural
gas (LNG) production capacity of the previously authorized Magnolia LNG
Project in Calcasieu Parish, Louisiana (Docket No. CP14-347-000) from 8
million metric tonnes per annum (MTPA) to 8.8 MTPA. The increased LNG
production capacity would be achieved through the optimization of
Magnolia LNG's final design for the terminal, including additional and
modified process equipment.
    The draft supplemental EIS assesses the potential changes to the
air and noise emissions, and our reliability and safety engineering
analyses associated with the construction and operation of the
Production Capacity Amendment from what was presented in the final EIS
in Docket No. CP14-347-000 for the Magnolia LNG Project. The FERC staff
concludes that the proposed modifications, with the additional
mitigation measures recommended in the supplemental EIS, would continue
to avoid or reduce impacts to less than significant levels.
    The U.S. Department of Transportation's Pipeline and Hazardous
Materials Safety Administration, the U.S. Coast Guard, and the U.S.
Department of Energy participated as cooperating agencies in the
preparation of the supplemental EIS. Cooperating agencies have
jurisdiction by law or special expertise with respect to resources
potentially affected by the proposal and participate in the analysis
conducted under the National Environmental Policy Act.
    The Commission mailed a copy of the Notice of Availability to
federal, state, and local government representatives and agencies;
elected officials; environmental and public interest groups; Native
American tribes; potentially affected landowners and other interested
individuals and groups; and newspapers and libraries in the project
area. The draft supplemental EIS is only available in electronic
format. It may be viewed and downloaded from the FERC's website
(www.ferc.gov), on the Environmental Documents page (https://www.ferc.gov/industries/gas/enviro/eis.asp). In addition, the draft
supplemental EIS may be accessed by using the eLibrary link on the
FERC's website. Click on the eLibrary link (https://www.ferc.gov/docs-filing/elibrary.asp), click on General Search, and enter the docket
number in the ``Docket Number'' field, excluding the last three digits
(i.e., CP19-19). Be sure you have selected an appropriate date range.
For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.
    Any person wishing to comment on the draft supplemental EIS may do
so. Your comments should focus on draft supplemental EIS's disclosure
and discussion of potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts. To
ensure consideration of your comments on the proposal in the final
supplemental EIS, it is important that the Commission receive your
comments on or before 5:00 p.m. Eastern Time on November 18, 2019.
    For your convenience, there are three methods you can use to submit
your comments to the Commission. The Commission encourages electronic
filing of comments and has staff available to assist you at (866) 208-
3676 or<EMAIL_ADDRESS>Please carefully follow these
instructions so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature on the Commission's website (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for submitting brief,
text-only comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature on the Commission's website (www.ferc.gov) under the link to
Documents and Filings. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
eRegister. If you are filing a comment on a particular project, please
select ``Comment on a Filing'' as the filing type; or
    (3) You can file a paper copy of your comments by mailing them to
the following address. Be sure to reference the project docket number
(CP19-19-000) with your submission: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE, Room 1A,
Washington, DC 20426.
    Any person seeking to become a party to the proceeding must file a
motion to intervene pursuant to Rule 214 of the Commission's Rules of
Practice and Procedures (18 CFR part 385.214). Motions to intervene are
more fully described at http://www.ferc.gov/resources/guides/how-to/intervene.asp. Only intervenors have the right to seek rehearing or
judicial review of the Commission's decision. The Commission grants
affected landowners and others with environmental concerns intervenor
status upon showing good

cause by stating that they have a clear and direct interest in this
proceeding which no other party can adequately represent. Simply filing
environmental comments will not give you intervenor status, but you do
not need intervenor status to have your comments considered.
    Questions?
    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website (www.ferc.gov) using the eLibrary link. The eLibrary link
also provides access to the texts of all formal documents issued by the
Commission, such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription that allows you to keep track of all formal issuances and
submittals in specific dockets. This can reduce the amount of time you
spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: September 27, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-21494 Filed 10-2-19; 8:45 am]
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[Federal Register Volume 81, Number 116 (Thursday, June 16, 2016)]
[Notices]
[Pages 39274-39275]
[FR Doc No: 2016-14212]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Pediatric Oncology
Subcommittee of the Oncologic Drugs Advisory Committee. The general
function of the committee is to provide advice and recommendations to
the Agency on FDA's regulatory issues. The meeting will be open to the
public.

DATES: The meeting will be held on June 28, 2016, from 8 a.m. to 3:15
p.m., and June 29, 2016, from 8 a.m. to 4:15 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Lauren D. Tesh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: On June 28, 2016, information will be presented to gauge
investigator interest in exploring potential pediatric development
plans for four products in various stages of development for adult
cancer indications. The subcommittee will consider and discuss issues
concerning diseases to be studied, patient populations to be included,
and possible study designs in the development of these products for
pediatric use. The discussion will also provide information to the
Agency pertinent to the formulation of written requests for pediatric
studies, if appropriate. The products under consideration are: (1)
VENETOCLAX, application sponsored by AbbVie, Inc.; (2) TAZEMETOSTAT,
application sponsored by Epizyme, Inc.; and (3) ATEZOLIZUMAB,
application sponsored by Roche/Genentech.
    On June 29, 2016, during the morning session, information will be
presented to gauge investigator interest in exploring potential
pediatric development plans for two products in various stages of
development for adult cancer indications. The subcommittee will
consider and discuss issues concerning diseases to be studied, patient
populations to be included, and possible study designs in the
development of these products for pediatric use. The discussion will
also provide information to the Agency pertinent to the formulation of
written requests for pediatric studies, if appropriate. The products
under consideration are: (1) LOXO-101, application sponsored by Loxo
Oncology, Inc.; and (2) ENTRECTINIB, application sponsored by Ignyta,
Inc.
    During the afternoon session, information will be presented on the
current unmet clinical need in the nearly uniformly fatal brain tumor,
diffuse intrinsic pontine glioma (DIPG), which occurs predominantly in
the pediatric age group. The diagnosis of DIPG is typically based on
characteristic radiographic and clinical features in lieu of brain
biopsy, and histological confirmation. Recent data has demonstrated
that the biology and pathophysiology of these tumors differ. There are
no approved drugs for this disease. Clinical investigators seek to
exploit precision medicine approaches to DIPG and use potentially
predictive information from the genomic signature of tumors at either
diagnosis or relapse. This information can be used to select specific
molecularly targeted drugs based on the genetic aberrations of an
individual patient's tumor. The Agency will seek the input of the
subcommittee, including an assessment of benefit/risk given the
potential for an adverse event associated with a surgical intervention
in the brainstem.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views,

orally or in writing, on issues pending before the subcommittee.
Written submissions may be made to the contact person on or before June
21, 2016. Oral presentations from the public will be scheduled between
approximately 8:50 a.m. and 9:10 a.m., 11 a.m. and 11:20 a.m., 1:55
p.m. and 2:15 p.m., and 3:50 p.m. and 4:05 p.m. on June 28, 2016, and
between approximately 8:50 a.m. and 9:10 a.m., 10:55 a.m. and 11:15
a.m., and 3 p.m. and 3:20 p.m. on June 29, 2016. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before June 16, 2016. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by June 17, 2016.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Lauren D. Tesh at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: June 10, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-14212 Filed 6-15-16; 8:45 am]
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