SF-83 SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

NESHAP for Reinforced Plastic Composites Production (40 CFR part 63, subpart WWWW)

1.  Identification of the Information Collection

1(a)  Title of the Information Collection

NESHAP for Reinforced Plastic Composites Production (40 CFR part 63, subpart WWWW) (Renewal)

1(b)  Short Characterization/Abstract

The National Emission Standards for Hazardous Air Pollutants (NESHAP) for reinforced plastic composites (RPC) production operations and processes, published at 40 CFR part 63, subpart WWWW, were proposed on August 2, 2001 (66 FR 40323), and promulgated on April 21, 2003 (68 FR 19375).  These standards regulate fugitive emissions from reinforced plastic composites (RPC) production operations and processes resulting from hazardous air pollutants (HAPs) evaporating from the resins, gel coats, and cleaning solvents.  The owner or operator of a RPC manufacturing facility must control HAPs emissions by either limiting the HAP content of materials used and using non-atomized spray application in the manufacturing processes or by using an enclosure and add-on control device.  This information is being collected to assure compliance with 40 CFR part 63, subpart WWWW.

Owners and operators of affected sources are subject to the monitoring, recordkeeping and reporting requirements of 40 CFR part 63, subpart A, the General Provisions, unless specified otherwise in the regulation.  This rule requires sources to submit initial notifications, conduct performance tests if source is using an add-on control device, and submit periodic compliance reports.  In addition, sources are required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation if using an add-on control device; any period during which the monitoring system is inoperative; parametric monitoring data; system maintenance and calibration; and work practices to demonstrate initial and ongoing compliance with the regulation.

In the development of this Information Collection Request (ICR), we reviewed the Office of Management and Budget (OMB) Terms of Clearance (TOC) section on the active ICR.  There were no comments in the TOC section.

We have determined that there is approximately an average of 504 respondents (i.e., 488 existing and 16 new RPC manufacturing facilities) subject to NESHAP, subpart WWWW.  This information was confirmed with the rule lead addressing this source category at the Office of Air Quality Planning and Standards, information available in the active ICR, and existing background industry information gathered during the development of the rule and on EPA databases.

2.  Need for and Use of the Collection

2(a)  Need/Authority for the Collection

The Clean Air Act (ACT) provides authority to the Agency to establish standards to control air pollution and to ensure compliance with promulgated regulations through adequate recordkeeping and reporting by the affected industries (i.e., respondents).  The regulations include: the New Source Performance Standards (NSPS) under section 111 of the Act; the National Emission Standards for Hazardous Air Pollutants (NESHAP) which includes the original NESHAP standards and the more recent Maximum Achievable Control Technology (MACT) or NESHAP-MACT standards under section 112 of the Act; and the emission guidelines for the designated types of incinerators under section 129 of the Act.

2(b)  Practical Utility/Users of the Data

The recordkeeping and reporting requirements in the standard(s) are used by regulatory agencies, the public and the regulated community for a variety of reasons including the determination of the respondent’s compliance status, analytical studies to demonstrate compliance trends, and evaluations regarding the efficacy of the promulgated regulations.

The required recordkeeping and reporting are also used to: 1) certify compliance with the regulations; 2) determine the respondent’s compliance with the designated emission limitation(s); 3) notify regulatory agencies when a standard is violated; 4) evaluate continuous compliance through the use of emission or operational parameter monitors; and 5) ensure that plant personnel are following the required procedures and are periodically trained as indicated.

3.  Nonduplication, Consultations, and Other Collection Criteria

3(a)  Nonduplication

The standards do not require the duplication in the collection and reporting of information.  If the subject standards have not been delegated, the information is sent directly to the appropriate Environmental Protection Agency (EPA) regional office.  Otherwise, the information is sent directly to the delegated state or local agency.  If a state or local agency has adopted its own similar standards to implement the Federal standards, a copy of the report submitted to the state or local agency can be sent to the Administrator in lieu of the report required by the Federal standards.

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

An announcement of a public comment period for the renewal of this ICR was published in the Federal Register (70 FR 24020) on May 6, 2005.  No comments were received on the burden published in the Federal Register.

3(c)  Consultations

The estimated number of sources and assumptions for each category were based on a review of the standard, information available in the active ICR, existing industry information gathered during the development of the rule and on EPA databases, and consultation with Keith Barnett, the rule lead addressing this source category at the Office of Air Quality Planning and Standards (OAQPS).

Any pertinent comments received since the last ICR renewal including those submitted in response to the first federal register notice announcing the renewal of this ICR, have been reviewed.  In this case, no comments were received.  It has been determined that no further consultations with industry are necessary to calculate the burden for this renewal.  It should be noted that the Agency involved RPC manufacturers, including 17 small firms, and their trade association in the development of this NESHAP and the associated recordkeeping and reporting requirements.

3(d)  Effects of Less Frequent Collection

The effect of less frequent collection would be a decrease in the margin of assurance that facilities are achieving the emission reductions mandated by the Clean Air Act through the promulgation of the applicable regulations.  In addition, the likelihood of detecting the poor operation and maintenance of control equipment decreases and the detection of noncompliance becomes problematic.

3(e)  General Guidelines

The reporting and the recordkeeping requirements do not violate the regulations established by Office of Management and Budget (OMB) at 5 CFR part 1320, section 1320.5.  However, most NESHAP standards and a few NSPS standards require records to be kept more than three years.  In general, these standards require the respondents to maintain all records, including reports and notifications, for five years.  The five-year record retention requirement is consistent with the permit program at 40 CFR part 70, and the five-year statute of limitations on which the permit program is based.

The retention of records for five years allows EPA to establish the compliance history of the respondent for purposes of determining the appropriate level of enforcement action.  Historically, EPA notes that the most flagrant violations have extended beyond a five-year period.  If records are retained for less than five years, EPA would be deterred from pursuing the most flagrant violations due to the destruction of records documenting noncompliance.

3(f)  Confidentiality

Any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, chapter 1, part 2, Subpart B - Confidentiality of Business Information (see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3(g)  Sensitive Questions

The recordkeeping and reporting requirements do not contain sensitive questions.

4.  The Respondents and the Information Requested

4(a)  Respondents/SIC Codes

Respondents are owners or operators of RPC manufacturing facilities.  The following processes and operations constitute RPC manufacturing: closed mold and open mold fiberglass manufacturing; resin and gel coat mixing; resin and gel coat application equipment cleaning; and resin and gel coat storage.  The Standard Industrial Classification (SIC) code(s) and corresponding North American Industry Classification System (NAICS) for the respondents are listed below.

Category	SIC

code	NAICS code	Examples of regulated entities

Industry

	3087

3084

3089

3088

3089

3999

3281

3713

3716

3792	325991

326122

326191

326199

327991

336211

336213

336214	Reinforced plastic composites production facilities that manufacture and/or repair intermediate and/or final products using HAP containing thermoset resins and gel coats.

Federal Government

	Federally owned facilities that manufacture and/or repair intermediate and/or final products using HAP containing thermoset resins and gel

coats.

 	This table is not meant to be exhaustive, but rather provides a guide for readers regarding the entities likely to be regulated by this standard.  To determine whether the standard applies to a particular entity, review the applicability provisions in the standard.

4(b)  Information Requested

(i)  Data Items

All data in this ICR that are recorded and/or reported are required by NESHAP for Wet-Formed Fiberglass Mat Production (40 CFR part 63, subpart WWWW).

	A source must make the following reports:

Notification Reports

Initial notification requirements	63.9(b)(1)

Notification of compliance status when a source becomes subject to the standard	63.9(h), 63.5755(a)

Notification that source is subject to special compliance requirements, if applicable	63.9(d)

Notification of performance test   SEQ CHAPTER \h \r 1 	63.7(b), 63.5755(a)

Rescheduled of performance test	63.7(b)(2)

Demonstration of continuous monitoring system	63.9(g), 63.5755(a)

Change in information already provided	63.9(j)

Request for an extension of compliance with relevant standard	63.9(c)

Reports

Application for approval of the construction or reconstruction of a new major affected source, or reconstruction of a major affected source 63.5(6)(d)

Performance test results	63.10(d)(2),

63.5755

Startup, shutdown and malfunction plan	63.6(e)(3), 63.5758(d)

Periodic startup, shutdown and malfunction reports	63.10(d)(5)(i), 63.5758

Progress reports for compliance extension (if applicable)	63.6(i)  SEQ CHAPTER \h \r 1

Semiannual compliance reports 	63.5758(b-c)

	A source must keep the following records:

Recordkeeping

Startup, shutdown and malfunction plan	63.6(e)(3)

All reports and notifications	63.10(b)(1)

Records of startup, shutdown, and malfunction of process equipment 63.10(b)(2)(i), (iv), (v)

Records of malfunctions of air pollution control equipment 63.10(b)(2)(ii)

Any applicability determination that demonstrates why owner or operator believes source is unaffected	63.10(b)(3)

Records of maintenance of air pollution control equipment 63.10(b)(2)(iii)

Records of flow monitoring system performance evaluations, malfunctions, calibrations, and adjustments	63.10(b)(2)(vi), (vii), (viii), (ix), (x), (xi), 63.10(c)

Documentation required for waiver of recordkeeping or reporting requirements (if applicable)	63.10(b)(2)(xii)

Documentation of initial notifications	63.10(b)(2)(xiv)

Five-year retention of records	63.10(b)(1),   SEQ CHAPTER \h \r 1

63.5764(b)

	Electronic Reporting

At the present, many respondents to Clean Air Act standards use monitoring equipment that automatically records parameter data.  Although personnel at the affected facility must evaluate the data, this internal automation has significantly reduced the burden associated with monitoring and recordkeeping at the plant site.

Also, regulatory agencies, in cooperation with the respondents, continue to create reporting systems to transmit data electronically.  However, electronic reporting systems are still not widely used.  At this time, it is estimated that approximately 10 percent of the respondents use electronic reporting.

(ii)  Respondent Activities

Respondent Activities

Read instructions.

Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports developing, acquiring, installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the purpose of 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.

Transmit, or otherwise disclose the information.

Regulatory agencies, to the extent possible, are relying more on automated techniques such as electronic submissions of reports, and are improving their tracking systems and database systems to enhance the use of these techniques.  However, electronic reporting systems are still

not widely used.  At this time, it is estimated that approximately 10 percent of the respondents use electronic reporting.

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

5(a)  Agency Activities

EPA conducts one or more of the following activities in connection with the acquisition, analysis, storage, and distribution of the required information.

Agency Activities

Observe initial performance tests and repeat performance tests if necessary.

Review notifications and reports, including performance test reports, and excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the AIRS Facility Subsystem (AFS).

5(b)  Collection Methodology and Management

The required data and reports can be evaluated on-site by conducting a partial compliance evaluation, full compliance evaluation or inspection, or through an off-site review of compliance monitoring records and reports.  Evaluation reports and inspection results are maintained by the Agency or delegated authority.

The results of these evaluations are entered into the AIRS Facility Subsystem (AFS) which is operated and maintained by EPA's Office of Compliance.  AFS is EPA(s database for the collection, maintenance, and retrieval of compliance data for approximately 125,000 industrial and government-owned facilities.  EPA uses the AFS for tracking air pollution compliance and enforcement by local and state regulatory agencies, EPA regional offices and EPA headquarters.  EPA and delegated authorities can retrieve and analyze the data.

5(c)  Small Entity Flexibility

The majority of the existing facilities subject to this NESHAP are classified as small businesses under the Small Business Administration definition (750 or fewer company employees.)  However, the impact on small businesses was accounted for in the development of the regulation.  In the final rule, EPA has provided the maximum degree of flexibility to minimize impacts on small businesses by providing several different compliance options, several of which require a minimum amount of recordkeeping and reporting requirements.  Small entities that would be subject to the regulation would not be systematically impacted more than larger entities.  Although the recordkeeping requirements are the same for small and large businesses, EPA considers these requirements the minimum needed to ensure compliance and, therefore, cannot reduce them further for small businesses.  Thus, EPA does not expect that any affected

source, including small businesses, will experience adverse impacts due to the reporting and recordkeeping requirements of this rule.

5(d)  Collection Schedule

The specific frequency for each information collection activity within this request is shown in Table 1, attached.

6.  Estimating the Burden and Cost of the Collection

Table 1 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry.  The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act.  Where appropriate, specific tasks and major assumptions have been identified.  Responses to this information collection are mandatory.

The 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.

6(a)  Estimating Respondent Burden

The respondent burden is shown in Table 1.  The labor hours in Table 1 are based on Agency studies and background documents from the development of the regulation, Agency knowledge and experience with the NESHAP program, the previously approved ICR, and any comments received.

6(b)  Estimating Respondent Costs

(i)  Estimating Labor Costs

This ICR uses the following labor rates:

Managerial	$97.46   ($46.41 + 110%)

Technical	$83.71   ($39.86 + 110%)

Clerical	$42.55   ($20.26 + 110%)

These rates are from the United States Department of Labor, Bureau of Labor Statistics, March 19, 2005, Table 2. Civilian Workers, by occupational and industry group.  The rates are from column 1, Total compensation. The rates have been increased by 110% to account for the benefit packages available to those employed by private industry.

(ii)  Estimating Capital/Startup and Operation and Maintenance Costs

The only costs to the regulated industry resulting from information collection activity required by the subject standard are operating and maintenance and  labor costs.  There are no capital/startup  costs.  The capital/startup costs are one-time costs when a facility becomes subject to the regulation.  This is based on the assumption that all existing sources are in compliance with initial rule requirements and the assumption that the monitoring devices are integral parts of the control devices necessary to determine whether these are operating properly.  The annual operation and maintenance costs are the ongoing costs to maintain the continuous emission monitors and other costs such as file storage, photocopying and postage.

(iii  Capital/Startup vs. Operation and Maintenance (O&M) Costs

The total annualized operation and maintenance cost to industry over the three-year period of this ICR is $22,000 (rounded).  Based on the assumptions discussed above, the only costs to industry result from other types of operation and maintenance costs, not related to operation of the monitoring equipment, which include file storage, photocopying and postage.  We have estimated that file storage and photocopying costs per response are estimated at $12.50 per hour of clerical labor.  First class postage is estimated at $7.63 per response for mailing to regulatory agencies.  The estimated operation, maintenance, and purchase of services costs averaged over the first 3 years are expected to be $22,000 (rounded) based on 1,077 responses and an average of one hour of clerical work per response for storage and photocopying.

There is no capital/startup cost associated with continuous monitoring equipment.  This is shown on the OMB 83-I form in section 14 as follows: block 4(a), Total annualized capital/startup costs; block 14(b), Total annual costs (O&M); block 14(c), Total annualized cost requested.  The numbers in block 14 of the OMB 83-I form are rounded to show the cost in thousands of dollars.

6(c)  Estimating Agency Burden and Costs

The only costs to the Agency are those associated with analysis of the reported information.  EPA's overall compliance and enforcement program includes activities such as the examination of records maintained by the respondents and the publication and distribution of collected information.

The average annual Agency cost during the three years of the ICR is estimated to be $125,414 (rounded).  This cost is based on the average hourly labor rate as follows:

Managerial	$56.02   (GS-13, Step 5, $35.01 x 1.6)

Technical	$41.57   (GS-12, Step 1, $25.98 x 1.6)

Clerical	$22.50   (GS-6, Step 3, $14.06 x 1.6)

These rates are from the Office of Personnel Management (OPM) “2005 General Schedule” which excludes locality rates of pay.  Details upon which this estimate is based appear in Table 2: Annual Burden and Cost to The Federal Government:  NESHAP for Reinforced Plastic Composites Production (40 CFR Part 63, Subpart WWWW).

6(d)  Estimating the Respondent Universe and Total Burden and Costs

The number of respondents is calculated using the following table which addresses the three years covered by this ICR.

Number of Respondents

	Respondents That Submit Reports	Respondents That Do Not Submit Any Reports

	Year	(A)

Number of New Respondents 1	(B)

Number of Existing Respondents	(C)

Number of Existing Respondents That Keep Records but Do Not Submit Reports	(D)

Number of Existing Respondents That Are Also New Respondents	(E)

Number of Respondents

(E=A+B+C-D)

1	16	488	0	0	488

2	16	504	0	0	504

3	16	520	0	0	520

Average	16	504	0	0	504

1 New respondents include sources with constructed, reconstructed and modified affected facilities.

To avoid double-counting respondents column D is subtracted.  As shown above, the average Number of Respondents over the three-year period of this ICR is 504.  This number appears on the OMB 83-I form in block 13(a), Number of respondents.

The total number of annual responses per year is calculated using the following table:

Total Annual Responses

(A)

Information Collection Activity	(B)

Number of Respondents	(C)

Number of Responses	(D)

Number of Existing Respondents That Keep Records But Do Not Submit Reports	(E)

Total Annual Responses

E=(BxC)+D

Notification of compliance status	16	1	0	16

Notification/application of construction	16	1	0	16

Notification of actual startup 	16	1	0	16

Notification of performance test and test plan	2	1.2	0	2.4

Report of performance test results 	2	1.2	0	2.4

Report of exceedances	100.8	2	0	201.6

Report of no exceedances	403.2	2	0	806.4

Report of startup, shutdown, malfunction 	16	1	0	16

Total

1,076.8

The number of Total Annual Responses, 1,077 (rounded), is shown in column E.  This number is shown on the OMB 83-I form in block 13(b), Total annual responses.

The Total Hours Requested is shown on the OMB 83-I form in block 13(c).  The total annual labor hours are 17,740 (rounded).  The total annual labor cost may be found in Table 1. Annual Respondent Burden and Cost: NESHAP for Reinforced Plastic Composites Production (40 CFR Part 63, Subpart WWWW).

The average annual Agency burden and cost over next three years is shown in Table 2. Annual Burden and Cost to the Federal/State Government: NESHAP for Reinforced Plastic Composites Production (40 CFR Part 63, Subpart WWWW).

6(e)  Bottom Line Burden Hours Burden Hours and Cost Tables

The detailed bottom line burden hours and cost calculations for the respondents and the Agency are shown in Tables 1 and 2, respectively.

(i) Respondent Tally

The Total Hours Requested is shown on the OMB 83-I form in block 13(c).  The annual labor costs are not shown on the OMB 83-I form.  The total annual labor costs are $1,432,143 (rounded).  Details regarding these estimates may be found in Table 1.  Furthermore, the annual public reporting and recordkeeping burden for this collection of information is estimated to average 17 hours per response.

The total annual capital/startup and O&M costs to the regulated entity are shown on the OMB 83-I form in block 14(c), Total annualized cost requested.  The cost calculations are detailed in Section 6(b)(iii), Capital/Startup vs. Operation and Maintenance (O&M) Cost.

(ii) The Agency Tally

The average annual Agency burden hours and cost over next three years is shown in Table 2.

6(f)  Reasons for Change in Burden

The increase in labor burden to industry from the most recently approved ICR from 13,785 hours to 17,740 is due to adjustments.  The increase in burden from the most recently approved ICR is primarily due to an increase from 435 to 488 on the number of existing sources and the assumptions that all existing sources are complying in full compliance with the rule requirements.  We have estimated that there would be an average of 16 new respondents each year over the three-year period of this ICR subject to this standard.

The total annualized capital and operations and maintenance (O&M) costs increase from $15,807 to $21,680 due to an increase in the number of respondents.  This is based on the two assumptions: 1) there are no startup capital costs since monitors are an integral part of the control equipment necessary to determine if it is operating properly, and costs cannot be attributed to the rule; 2) the O&M costs are a result of other costs, not related to operation of the monitoring equipment, such as costs for clerical support for filing, storage, photocopying, and postage, therefore, such costs would increase with an increase on the number of respondents.

	The Federal government burden decreased from 3,707 to 3,074 hours due to the deletion of burden and costs associated with inspection and enforcement activities that are exempt under the Paperwork Reduction Act.

6(g)  Burden Statement

The annual public reporting and recordkeeping burden for this collection of information is estimated to average 16 hours per response.  Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose, or provide information to or for a Federal agency.  This includes the time needed to review instructions; to 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; to adjust the existing ways to comply with any previously applicable instructions and requirements; to train personnel to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to 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 valid OMB Control Number.  The OMB Control Numbers for EPA’s regulations are listed at 40 CFR part 9 and 48 CFR chapter 15.

	To comment on the Agency’s need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques,  EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OECA-2005-0049, which is available for online viewing at  www.regulations.gov,  or in person viewing at the Enforcement and Compliance  Docket and  Information Center in the EPA Docket Center (EPA/DC),  EPA West, Room B102, 1301 Constitution Avenue, NW, Washington, DC  The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.  The telephone number for the Reading  Room is<PHONE_NUMBER>, and the telephone number for the Enforcement and Compliance Docket and Information Center is<PHONE_NUMBER>.  An electronic version of the public docket is available through EPA Dockets www.regulations.gov.  This site can be used to submit or view public comments, access the index listing of the contents of the public docket and to access those documents in the public docket that are available electronically.  When in the system, select “search,” then key in the Docket ID number identified above.  You can also send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention Desk Officer for EPA.  Please include the EPA Docket Number:  EPA-HQ OECA-2005-0049, and OMB Control Number 2060-0509 in any correspondence.

Part B of the Supporting Statement

This part is not applicable because no statistical methods were used in collecting this information.

Table 1.  Annual Respondent Burden and Cost:  NESHAP for Reinforced Plastic Composites Production

(40 CFR Part 63, Subpart WWWW)

Burden item

(A)

Person-

hours per

occurrence

(B)

No.  of

occurrences

per respondent

per year

(C)

Person-

hours per

respondent

per year

(C=AxB)

(D)

Respondents

per year  a

(E)

Technical

person-

hours per

year

(E=CxD)

(F)

Management

person-hours

per year

(Ex0.05)

(G)

Clerical

person-

hours per 	year

(Ex0.1)

(H)

Cost, $  b

1.  Applications

N/A

2.  Survey and Studies

N/A

3.  Acquisition, Installation,         and Utilization of  Technology and  Systems

/A

4.  Reporting Requirements

  A.  Read instructions:

     i.  Facilities with 4 groups of           operations

12

1

12

14.9

178.8

8.94

17.9

$16,600.29

     ii.  Facilities with 5 groups of          operations

13

1

13

1.1

14.3

0.72

1.43

1,328.05

   B.  Required activities:

   Sources with add-on controls

     i.  Initial performance test  c

320

1

320

2

640.0

32.0

64.0

59,416.32

     ii.  Repeat of performance test

320

1

320

0.4

128.0

6.4

12.8

11,883.26

     iii.  Operation, maintenance,          monitoring plan

40

1

40

2

80.0

4.0

8.0

7,427.04

     iv.  Startup, shutdown,                   malfunction plan

20

1

20

2

40.0

2.0

4.0

$3,713.52

     v.  Monitoring of operating            parameters and equipment:  d

Included in 5E

  C.  Gather Existing Information

Included in 5D, 5E

  D.  Write report  a, c

     i.  Notification of compliance        status

4

1

4

16

64.0

3.2

6.4

$5,941.63

     ii.  Notification of                          construction/ reconstruction  a

2

1

2

16

32.0

1.6

3.2

$2,970.82

     iii.  Notification of actual               startup

2

1

2

16

32.0

1.6

3.2

$2,970.82

     iv.  Notification of                         performance test

2

1

2

2

4

0.2

0.4

$371.35

     v.  Reports of performance            test results

Included in 4B

     vii.  Report of exceedances  f

16

2

32

100.8

3,225.6

161.3

322.6

$299,461.90

     viii.  Report of no exceedances

8

2

16

403.2

6,451.2

322.6

645.1

$598,919.55

     ix.  Startup, shutdown,

     malfunction report  g

2

1

2

16

32.0

1.6

3.2

$2,970.82

5.  Recordkeeping Requirements

  A.  Read instructions

Included in 4A

  B.  Plan activities

Included in 4B

  C.  Implement activities

Included in 4B

  D.  Develop record system                (spreadsheets):  h

     i.  System for low HAP resin	4	1

4

14

56.0

2.8

5.6

$5,198.93

     ii.  System for work practices	1	1

1

16

16.0

0.8

1.6

$1,485.41

     iii.  System for add-on control       devices	2	1

2

2

4.0

0.2

0.4

$371.35

  E.  Time to enter and transmit all   information into record system  h

     i.  Enter information on low           HAP resin

10

1

10

396

3,960

198.0

396.0

$367,638.48

     ii.  Enter information on work        practices and operating                  parameters

N/A

  F.  Develop operator training         course and keep records of            operators taken it

10

1

10

16

160

8.0

16.0

$14,854.08

  G.  Time to train personnel:

     i.  Small facilities (less than           100 employees)

2

1

2

13.1

26.2

1.3

2.6

$2,430.53

0.4

1

0.4

413.3

165.3

8.3

16.6

$15,348.26

     ii.  Medium facilities (100-250      employees)

4

1

4

1.8

7.2

0.4

0.7

$671.48

0.8

1

0.8

55.4

44.32

2.2

4.4

$4,109.98

     iii.  Large facilities (more than       250 employees)

8

1

8

1.1

8.8

0.4

0.8

$813.93

1.6

1

1.6

35.3

56.5

2.8

5.7

$5,245.04

  H. Time for audits

N/A

TOTAL LABOR  BURDEN AND COST

15,426.2

771.3

1,542.6

$1,432,142.83

TOTAL LABOR HOURS (Rounded)

17,740

$1,432,143

Assumptions:

a  There is an average of 488 existing reinforced plastic composites facilities (or RPC) subject to NESHAP subpart WWWW.  We have assumed that there will be an average of 16 new RPC facilities each year over the three year period of this ICR of which 93 percent (ir 14.9) will consist of facilities with 4 groups of operations and 7 percent of facilities with 5 groups of  operations.  There is an average of 504  existing respondents per year over the next three year period of this ICR.

b  This ICR uses the following labor rates: $97.46 per hour for Executive, Administrative, and Managerial labor; $83.71 per hour for Technical labor, and $42.55 per hour for Clerical labor.  These rates are from the United States Department of Labor, Bureau of Labor Statistics, March 19, 2005, (Table 2. Civilian Workers, by occupational and industry group.(  The rates are from column 1, (Total compensation.(  The rates have been increased by 110% to account for the benefit packages available to those employed by private industry.

c    SEQ CHAPTER \h \r 1 New respondents have to comply with the initial rule requirements including notifications and performance tests.  We have assumed that two new respondents per year will install add-on controls equipment and therefore, will be require to conduct an initial performance test.  We have assumed that performance tests are repeated by 20 percent of the respondents.

d Monitoring and recordkeeping of operations for respondents with enclosures and add-on control devices include: 1) specific operating parameters for each control device established during the performance test, 2) start-up, shutdown, and malfunctions of equipment,  and 3) work practices.

e Monitoring and recordkeeping of operations for respondents that comply by limiting the HAP content of their raw materials include: 1) monitoring and recording in a spreadsheet the monthly consumption of material and the weighted-average HAP content over the past 12 months, and 2) work practices.  However, if all the materials in an operation meet the HAP content limit, then each respondent would need only to record HAP content and would not need to track monthly consumption or record the computations.    SEQ CHAPTER \h \r 1 For open molding and centrifugal casting operations, respondents would also have the option of averaging among thirteen different processes (open molding) and two different processes (centrifugal casting to calculate the monthly average of the actual and allowable emissions for the combined open molding and centrifugal casting operations.

f  We have assumed that approximately 80 percent of the 504 existing respondents (403.2) will report no excess emissions twice a year and approximately 20 percent (100.8) will report no excess emissions twice a year.

g  We have assumed that  all RPC facilities with add-on controls (12 existing and 2 new each year or an average of 16) will have at least one startup, shutdown or malfunction (SSM) that is not managed according to the SSM plan.

h    New respondents (16) have to develop a record system.  In addition, existing RPC facilities have to record operational data.  In general, the following monitoring is required:  1) facilities with open molding and/or centrifugal casting operations (354 existing and 14 new each year or an average of 396 per year) would have to record for low HAP resins; 2) facilities with add-on controls (12 existing and 2 new or an average of 16 RPCs per year) would have to record add-on control devices operating parameters; and 3) all facilities (504) need to keep records of its work practices.  Since operating parameters for control equipment and standard work practices are already monitored by industry for other purposes, we are not attributing these burdens to the rule.

i    We have assumed that he amount of time it takes a respondent to train its employees would vary with the number of employees at its facility.  We have also   SEQ CHAPTER \h \r 1 assumed that the distribution in size of the new respondents would be identical to that of the existing PRC universe.  Therefore, we have assumed that 82 percent of the respondents would be small business (i.e., 413.3 RPCs existing and 13.1 new RPC per year), 11 percent (ie., 55.4 existing RPCs and 1.8 new RPCs per year), would be medium business, and 7 percent (i.e., 35.3 existing RPCs and 1.1 new RPCs) are large business.  Furthermore, we have assumed that respondents will be providing full training to new employees only.  Therefore, it will take existing respondents to train its new employees 20 percent of the time it takes new respondents to train all employees, assuming the same size business.

  Table 2 .  Annual Burden and Cost for The Federal Government:

NESHAP for Reinforced Plastic Composites Production (40 CFR Part 63, Subpart WWWW)

	Activity

(A)

EPA person-

hours per

occurrence

(B)

No. of

occurrences

per plant

per year

(C)

EPA person-

hours per

plant per

year

(C=AxB)

(D)

Plants

per

year  a

(E)

Technical

person-hours

per year

(E=CxD)

(F)

Management

person-hours

per year

(Ex0.05)

(G)

Clerical

person-

hours per

year

(Ex0.1)

(H)

Cost, $ b

Notification of  applicability  a

2

1

2

2

4.0

0.2

0.4

$186.48

Notification of intent to construct a major source and review application

12

1

12

16

32.0

10.2

3.2

$2,300.04

Notification of start of construction

2

1

2

16

32.0

1.6

3.2

$1,491.87

Notification of actual startup

2

1

2

16

32.0

1.6

3.2

$1,491.87

Notification of initial performance test and test plan

12

1.2

14.4

2

28.8

1.4

2.8

$1,343.14

Report of performance test results including operating parameters

12

1.2

14.4

2

28.8

1.4

2.8

$1,343.14

Notification of compliance status

2

1

2

16

32.0

1.6

3.2

$1,491.87

Review reports of excess emissions  c

4

2

8

100.8

806.4

40.3

80.6

                     $37,593.15

Review reports of no excess

emissions  c

2

2

4

403.2

1,612.8

80.6

161.3

$75,188.56

Review of startup, shutdown, malfunction report  d

4

1

4

16.0

64.0

3.2

6.4

$2,983.74

Subtotal Burden and Cost

2,672.8

133.64

267.3

$125,413.86

TOTAL ANNUAL BURDEN AND COST (rounded)

3,074

$125,414

Assumptions:

a   There is an average of 488 existing reinforced plastic composites facilities (or RPC) subject to NESHAP subpart WWWW.  We have assumed that there will be an average of 16 new RPC facilities each year over the three year period of this ICR.  Therefore, there is an average of 504  existing respondents per year over the next three year period of this ICR.  We have assumed that 82 percent (or 413.3) of the existing RPC facilities are small business, 11 percent (or 55.4) are medium size facilities and 7 percent (or 35.3) are  large facilities.  Furthermore, we have assumed that 93 percent (or 14.9) of the new RPC facilities will consist of an average of four groups of operations and 7 percent (or 1.1) will consist of five groups of operations.

b   This cost is based on the following labor rates which incorporates a 1.6 benefits multiplication factor to account for government overhead expenses:  Managerial rate of $56.02 (GS-13, Step 5, $35.01 x 1.6), Technical rate of $41.57 (GS-12, Step 1, $25.98 x 1.6), and Clerical rate of $22.50 (GS-6, Step 3, $14.06 x 1.6).  These rates are from the Office of Personnel Management (OPM) (2005 General Schedule( which excludes locality rates of pay.

c   We have assumed that approximately 80 percent of the 505 respondents (or 404) will report no excess emissions twice a year and approximately 20 percent (or 101) will report no excess emissions twice a year.

d   We have assumed that all RPC facilities with add-on controls (12 existing and 2 new each year or an average of 16) will have at least one startup, shutdown, or malfunction occurrence that is not managed according to the plan.

 PAGE  19


[Federal Register: October 4, 2007 (Volume 72, Number 192)]
[Notices]
[Page 56732-56733]
[DOCID:fr04oc07-44]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR07-19-000]

National Fuel Gas Distribution Corporation; Notice of Petition
for Rate Approval

September 27, 2007.
    Take notice that on September 20, 2007, National Fuel Gas
Distribution Corporation (Distribution) filed a petition for NGPA
section 311 to amend the transportation rate currently in effect,
pursuant to section 284.123(b)(2) of the Commission's regulations.
Distribution requests that the Commission approve: (1) The reduction in
maximum transportation rate for transportation provided in New York
from currently effective $0.6725 per Mcf to $0.5784 per Mcf; (2) the
reduction in maximum transportation rate, for transportation provided
in Pennsylvania, from currently effective $0.4655 per Mcf to $0.3590
per Mcf; and (3) the same currently effective minimum transportation
rate of $0.10 per Mcf for transportation provided in New York and
Pennsylvania, pursuant to NGPA section 311.
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in

determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Any person wishing to
become a party must file a notice of intervention or motion to
intervene, as appropriate. Such notices, motions, or protests must be
filed on or before the date as indicated below. Anyone filing an
intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time Monday, October 15, 2007.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-19587 Filed 10-3-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 5 (Wednesday, January 8, 2014)]
[Notices]
[Pages 1426-1427]
[FR Doc No: 2014-00060]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket Number NHTSA-2013-0138]

Reports, Forms, and Record Keeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA), U.S.
Department of Transportation.

ACTION: Request for public comment on extension of a currently approved
collection of information.

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

SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of

information, including extensions and reinstatement of previously
approved collections.
    This document describes a collection of information for which NHTSA
intends to seek OMB approval.

DATES: Comments must be received on or before March 10, 2014.

ADDRESSES: You may submit comments identified by DOT Docket No. NHTSA-
2013-0138 by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays. Telephone: 1-800-647-
5527.
     Fax:<PHONE_NUMBER>.
    Instructions: All submissions must include the agency name and
docket number for this proposed collection of information. Note that
all comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://DocketInfo.dot.gov.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov. or the street
address listed above. Follow the online instructions for accessing the
dockets.

FOR FURTHER INFORMATION CONTACT: Alex Ansley, Recall Management
Division (NVS-215), Room W46-412, NHTSA, 1200 New Jersey Ave.,
Washington, DC 20590. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulation, see 5 CFR
1320.8(d), an agency must ask for public comment on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (iii) how to enhance the quality, utility, and clarity of the
information to be collected; and
    (iv) how to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g. permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following collection of information:
    Title: Names and Addresses of First Purchasers of Motor Vehicles.
    Type of Request: Extension of a currently approved information
collection.
    OMB Control Number: 2127-0044.
    Affected Public: Businesses or others for profit.
    Abstract: Pursuant to 49 U.S.C. 30117(b), a manufacturer of a motor
vehicle or tire (except a retread tire) must maintain a record of the
name and address of the first purchasers of each vehicle or tire it
produces and, to the extent prescribed by regulation of the Secretary,
must maintain a record of the name and address of the first purchaser
of replacement equipment (except a tire) that the manufacturer
produces.
    Vehicle manufacturers presently collect and maintain purchaser
information for business reasons, such as for warranty claims
processing and marketing, and experience with this statutory
requirement has shown that manufacturers have retained this information
in a manner sufficient to enable them to expeditiously notify vehicle
purchasers in the case of a safety recall. Based on industry custom and
this experience, NHTSA therefore determined that the regulation
mentioned in 49 U.S.C. 30117(b) was unnecessary as to vehicle
manufacturers. As an aside, the requirement for maintaining tire
purchaser information are contained in 49 CFR part 574, Tire
Identification and Recordkeeping, and the burden of that information
collection is not part of this information collection.
    Estimated annual burden: Zero. As a practical matter, vehicle
manufacturers are presently collecting from their dealers and then
maintaining first purchaser information for their own commercial
reasons. Therefore, the statutory requirement does not impose any
additional burden.
    Number of respondents: We estimate that there are roughly 1,000
manufacturers of motor vehicles that collect and keep first purchaser
information.

    Issued on: January 2, 2014.
Jennifer T. Timian,
Chief, Recall Management Division, NHTSA.
[FR Doc. 2014-00060 Filed 1-7-14; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 84, Number 196 (Wednesday, October 9, 2019)]
[Rules and Regulations]
[Pages 54032-54033]
[FR Doc No: 2019-21764]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2019-0744]

Safety Zone; 2019 Fleet Week Fireworks Display, San Francisco
Bay, San Francisco, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the safety zone for the 2019
Fleet Week Fireworks Display in the Captain of the Port, San Francisco
area of responsibility during the dates and times noted below. This
action is necessary to protect life and property of the maritime public
from the hazards associated with the fireworks display. During the
enforcement period, unauthorized persons or vessels are prohibited from
entering into, transiting through, or anchoring in the safety zone,
unless authorized by the Patrol

Commander (PATCOM) or other federal, state, or local law enforcement
agencies on scene to assist the Coast Guard in enforcing the regulated
area.

DATES: The regulation in 33 CFR 165.1191, Table 1, Item number 21, will
be enforced from 11 a.m. on October 12, 2019 through 9:40 p.m. on
October 12, 2019, or as announced via Broadcast Notice to Mariners.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Lieutenant Jennae Cotton, Waterways Management, U.S.
Coast Guard Sector San Francisco; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
established in 33 CFR 165.1191 Table 1, Item number 21 for the 2019
Fleet Week Fireworks Display from 11 a.m. on October 12, 2019 until
9:40 p.m. on October 12, 2019, or as announced via Broadcast Notice to
Mariners. The 2019 Fleet Week Fireworks Display will commence at
approximately 9 p.m. on October 12, 2019. This notice is issued under
authority of 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-6, and
160.5; Department of Homeland Security Delegation No. 0170.1.
    The safety zone will extend to all navigable waters of the San
Francisco Bay, from surface to bottom, within a circle formed by
connecting all points 100 feet out from the fireworks barge during the
loading, transit, and arrival of the fireworks barge from the loading
location to the display location and until the start of the fireworks
display. From 11 a.m. on October 12, 2019 until 5 p.m. on October 12,
2019, the fireworks barge will be loading pyrotechnics from Pier 50 in
San Francisco, CA. The fireworks barge will remain at the loading
location until its transit to the display location. From 7:30 p.m. to 8
p.m. on October 12, 2019 the loaded fireworks barge will transit from
Pier 50 to the launch site near Pier 3 in approximate position
37[deg]48'01'' N, 122[deg]23'27'' W (NAD 83) where it will remain until
the conclusion of the fireworks display. Upon the commencement of the
10-minute fireworks display, scheduled to begin at approximately 9 p.m.
on October 12, 2019, the safety zone will increase in size and
encompass all navigable waters of San Francisco Bay, from surface to
bottom, within a circle formed by connecting all points 1,000 feet out
from the fireworks barge near Pier 3 in approximate position
37[deg]48'01'' N, 122[deg]23'27'' W (NAD 83). This safety zone will
terminate at 9:40 p.m. on October 12, 2019, or as announced via
Broadcast Notice to Mariners.
    In addition to this notice in the Federal Register, the Coast Guard
plans to provide notification of the safety zone and its enforcement
period via the Local Notice to Mariners.
    Under the provisions of 33 CFR 165.1191, unauthorized persons or
vessels are prohibited from entering into, transiting through, or
anchoring in the safety zone during all applicable effective dates and
times, unless authorized to do so by the PATCOM or other Official
Patrol, which is defined as a federal, state, or local law enforcement
agency on scene to assist the Coast Guard in enforcing the regulated
area. Additionally, each person who receives notice of a lawful order
or direction issued by the PATCOM or Official Patrol shall obey the
order or direction. The PATCOM or Official Patrol may, upon request,
allow the transit of commercial vessels through regulated areas when it
is safe to do so.
    If the Captain of the Port determines that the regulated area need
not be enforced for the full duration stated in this notice, a
Broadcast Notice to Mariners may be used to grant general permission to
enter the regulated area.

    Dated: September 30, 2019.
Howard H. Wright,
Captain, U.S. Coast Guard, Alternate Captain of the Port, San
Francisco.
[FR Doc. 2019-21764 Filed 10-8-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 156 (Tuesday, August 15, 2017)]
[Notices]
[Pages 38695-38696]
[FR Doc No: 2017-17206]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1197]

The Food and Drug Administration's Proposed Method for Adjusting
Data on Antimicrobials Sold or Distributed for Use in Food-Producing
Animals Using a Biomass Denominator; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability for public comment of a proposed method for applying a
food animal biomass denominator to annual data on antimicrobials sold
and distributed for use in food animals in the United States. This
method will allow us to obtain a corrected estimate of antimicrobial
drug sales relative to the animal population potentially being treated
with those drugs, thereby lending further context to the antimicrobial
sales data we are collecting and analyzing.

DATES: Submit either electronic or written comments on the proposed
method by November 13, 2017.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 13, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 13, 2017. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-1197 for ``FDA's Proposed Method for Adjusting Data on
Antimicrobials Sold or Distributed for Use in Food-Producing Animals
Using a Biomass Denominator.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/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.
    Submit written requests for single copies of the proposed method to
the Policy and Regulations Staff (HFV-6), Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your requests. Persons with access to the Internet may
obtain the proposed method at either https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeAct

ADUFA/ucm042896.htm or in this docket at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Animal drug sponsors are required to report
annually to FDA the amount of antimicrobials sold or distributed for
use in food-producing animals and provide species-specific estimates of
the percentage of their drug product sales for use in any of the four
major food-producing species (cattle, swine, chickens, and turkeys)
identified on the approved product label (21 CFR 514.87(c)). FDA is
announcing the availability of a proposed method for using a biomass
denominator to adjust these sales data. The proposed method will
provide estimates of annual antimicrobial drug sales adjusted for the
size of the animal population (the animal biomass of each such species)
potentially being treated with those drugs. The adjusted estimates will
provide insight into broad shifts in the amount of antimicrobials sold
for use in food-producing animals and give the Agency a more nuanced
view of why sales increase or decrease over time in a manner that is
specific to U.S. animal production. Such analysis will also support our
ongoing efforts to encourage the judicious use of antimicrobials in
food-producing animals to help ensure the continued availability of
safe and effective antimicrobials for animals and humans.
    Application of a biomass denominator to normalize antimicrobial
sales data has been used internationally. In developing this proposal
for applying a biomass denominator to antimicrobial sales data in the
United States, FDA has considered methods being utilized and discussed
in other countries. FDA's intent in publishing the proposed method is
to initiate discussion with stakeholders on the biomass correction
method FDA is considering, and to seek comment on the methodology and
the utility of this type of data analysis.

    Dated: August 10, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-17206 Filed 8-14-17; 8:45 am]
 BILLING CODE 4164-01-P