SF-83 SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators

1.  Identification of the Information Collection

1(a)  Title of the Information Collection

State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60, subpart Ce and 40 CFR part 62, subpart HHH) (Renewal)

1(b)  Short Characterization/Abstract

This supporting statement addresses information collection activities imposed by the Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (Emission Guidelines), 40 CFR part 60, subpart Ce and 40 CFR part 62, subpart HHH.  Subpart Ce, promulgated on September 15, 1997, requires states or tribes to develop plans to implement the Emission Guidelines.  If approvable state or tribal plans were not developed, EPA was required to develop a Federal plan to implement the Emission Guidelines in such states or tribes.  The Federal plan, subpart HHH was promulgated on September 14, 2000.  For the purpose of this Information Collection Request (ICR), subparts Ce and HHH will be referred to as "the Emission Guidelines."  States and tribes may choose to impose more stringent requirements.  However, the burden estimates provided in this ICR assume that the state and tribal plans mirror the Emission Guidelines.

The Emission Guidelines require initial notifications, performance tests, and annual and semiannual reporting.  Owners or operators are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative.  These notifications reports, and records are essential in determining compliance.  Any owner or operator subject to the provisions of this part shall maintain a file of these measurements, and retain the file for at least five years following the date of such measurements, maintenance reports, and records.  All reports are sent to the state or tribal authority with an approved plan.  In the event that there is no such approved plan, the reports are sent directly to the EPA regional office.

The reporting and recordkeeping requirements differ for Hospital/Medical/Infectious Waste Incinerators (HMIWI) burning hospital waste and/or medical/infectious waste; for combustors co-firing hospital waste and/or medical/infectious waste with other fuels; and for incinerators burning only pathological, low-level radioactive, and/or chemotherapeutic waste.  For this reason, reporting and recordkeeping requirements are described separately for each of these three facility types.  This information is being collected to assure compliance with 40 CFR part 60, subpart Ce and 40 CFR part 63, subpart HHH.

Based on an EPA Office of Air Quality Planning and Standards (OAQPS) facility and emissions indexing effort for HMIWI, we have determined that there are 72 existing HMIWI located at 66 different facilities.  This standard regulates only existing sources, therefore, no new respondent will become subject to the regulation over the next three years.

Terms of Clearance

OMB requested that when EPA resubmits the ICR for renewal, the Agency should re-evaluate its assumption that no new sources would become subject to the reporting and recordkeeping requirements.  In addition, the agency should include a more detailed description of the estimates used to derive the annual operation and maintenance costs.

In response to OMB’s request, we reviewed the analysis conducted as part of the previous ICR that found that no new sources would become subject to the standards.  The Emission Guidelines only apply to existing sources.  New sources are subject to the Standards of Performance for Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60, subpart Ce). Therefore, no new sources are subject to this standard.  A more detailed description of the estimates used to derive the annual operation and maintenance costs is provided in section 6(b).

2.  Need for and Use of the Collection

2(a)  Need/Authority for the Collection

The EPA is charged under section 111(d)(1) of the Clean Air Act (CAA), as amended, to:

. . . prescribe regulations which shall establish a procedure similar to that provided by section 110 under which each State shall submit to the Administrator a plan which (A) establishes standards of performance for any existing source for any air pollutant (i) for which air quality criteria have not been issued or which is not included on a list published under section 108(a) . . . but (ii) to which a standard of performance under this section would apply if such existing source were a new source, and (B) provides for the implementation and enforcement of such standards of performance.

The EPA is required under section 129 of the Act, to establish guidelines for existing stationary sources that reflect the maximum achievable control technology (MACT) for achieving continuous emission reductions:

Section 129(a)(1)(A) states:

The Administrator shall establish performance standards and other requirements pursuant to section 111 and this section for each category of solid waste incineration units.  Such standards shall include emissions limitations and other requirements applicable to new units and guidelines (under section 111(d) and this section) and other requirements applicable to existing units.

Section 129(a)(2) states:

Standards applicable to solid waste incineration units promulgated under section 111 and this section shall reflect the maximum degree of reduction in emissions of air pollutants listed under section (a)(4) that the Administrator, taking into consideration the cost of achieving such emission reduction, and any non-air quality health and environmental impacts and energy requirements, determines is achievable for new or existing units in each category.

Section 129(b)(1) states:

Performance standards under this section and section 111 for solid waste incineration units shall include guidelines promulgated pursuant to section 111(d) and this section applicable to existing units.  Such guidelines shall include, as provided in this section, each of the elements required by subsection (a) (emissions limitations, notwithstanding any restriction in section 111(d) regarding issuance of such limitations), subsection (c) (monitoring), subsection (d) (operator training), subsection (e) (permits), and subsection (h)(4) (residual risk).

Subpart B of 40 CFR part 60 requires State plans to include monitoring, recordkeeping, and reporting provisions consistent with the emission guidelines.  In addition, section 114(a)(1) states that:

The Administrator may require any person who owns or operates any emission source, who manufactures emission control equipment or process equipment, who the Administrator believes may have information necessary for the purposes set forth in this subsection, or who is subject to any requirement of this Act (other than a manufacturer subject to the provisions of section 206(c) or 208 with respect to a provision of title II) on a one-time, periodic or continuous basis to:

(A) establish and maintain such records; (B) make such reports; (C) install, use, and maintain such monitoring equipment, and use such audit procedures, or methods; (D) sample such emissions (in accordance with such procedures or methods, at such locations, at such intervals, during such periods and in such manner as the Administer shall prescribe); (E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical; (F) submit compliance certifications in accordance with section 114(a)(3); and (G) provide such other information, as the Administrator may reasonably require; . . . .

In the Administrator's judgment, particulate matter (PM), carbon monoxide (CO), dioxins/furans (D/F), hydrogen chloride (HCl), sulfur dioxide (SO2), nitrogen oxides (NOx), lead (Pb), cadmium (Cd), and mercury (Hg) emissions from hospital, medical, or infectious waste incinerators contribute to air pollution that may reasonably be anticipated to endanger public health or welfare.  Therefore, the state and federal emission guidelines were promulgated for this source category at 40 CFR part 60, subpart Ce and 40 CFR part 62, subpart HHH.

2(b)  Practical Utility/Users of the Data

	The control of emissions of PM, CO, D/F, HCl, SO2, NOx, Pb, Cd, and Hg from HMIWIs requires not only the installation of properly designed equipment, but also the operation and maintenance of that equipment.  Emissions of these pollutants from HMIWIs are the result of operation of the facilities affected by the Emission Guidelines.  The subject standards are achieved by the capture and/or reduction of these pollutants using good combustion practices and appropriate filter and scrubber technology.

	The notifications required in the applicable regulations are used to inform the Designated Agency that a source is subject to the requirements of the regulations.  The reviewing authority may then inspect the source to check if the pollution control devices are properly installed and operated and the regulations are being met.  Performance test reports are needed as these provide a record of a source’s initial capability to comply with the emission standard, and serve as a record of the operating conditions under which compliance was achieved.  Operating conditions monitored include the highest maximum and lowest minimum operating parameters and exceedances of emission rates or operating parameters.  Annual and semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.  The information generated by the monitoring, recordkeeping, and reporting requirements described in this ICR is used by the Agency to ensure that facilities affected by the Emission Guidelines continue to operate the control equipment and achieve compliance with the regulation.  Adequate monitoring, recordkeeping, and reporting are necessary to ensure compliance with the applicable regulations, as required by the Emission Guidelines.  The information collected from recordkeeping and reporting requirements is also used for targeting inspections, and is of sufficient quality to be used as evidence in court.

3.  Nonduplication, Consultations, and Other Collection Criteria

The requested recordkeeping and reporting are required under 40 CFR part 60 subpart Ce, and 40 CFR part 62, subpart HHH.

3(a)  Nonduplication

 If the subject standards have not been delegated, the information is sent directly to the appropriate 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.  Therefore, no duplication exists.

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 Office of Air Quality Planning and Standards (OAQPS) is currently in the process of reviewing the Emission Guidelines as required by Section 129(a(5) of the Clean Air Act.  As part of the review, OAQPS, in consultation with industry, developed a HWIWI facility and emissions index for sources subject to these standards.  As a result, we were able to rely on the information from the facility and emissions index (dated March 2006) to obtain recent information on the universe of sources subject to the standard in order to estimate the burden of the Emission Guidelines on industry.

3(d)  Effects of Less Frequent Collection

Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the standards.  Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met.  If the information required by these standards was collected less frequently, the proper operation and maintenance of control equipment and the possibility of detecting violations would be less likely.

3(e)  General Guidelines

These reporting or recordkeeping requirements do not violate any of the regulations promulgated by OMB under 5 CFR part 1320, section 1320.5.  These standards require the respondents to maintain all records, including reports and notifications for at least five years.  This is consistent with the General Provisions as applied to the standards.  EPA believes that the five year records retention requirement is consistent the Part 70 permit program 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 a source, any pattern of non-compliance and to determine the appropriate level of enforcement action.  EPA has found that the most flagrant violators have violations extending beyond five years.  In addition, EPA would be prevented from pursuing the violators due to the destruction or nonexistence of essential records.

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 (CBI) (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 reporting or recordkeeping requirements in the standard do not include sensitive questions.

4.  The Respondents and the Information Requested

	4(a)  Respondents/SIC Codes

	The respondents to the recordkeeping and reporting requirements are owners or operators of hospital, medical, or infectious waste incinerators.  The United States Standard Industrial Classification (SIC) codes and corresponding North American Industry Classification System (NAICS) classifications for the respondents are listed in the table below.

40 CFR part 60, subpart Ce Source Categories	SIC Codes	NAICS Codes

Hospitals 	806	622110

Refuse Systems	4953	562213

Commercial Physical and Biological Research	8731	541740

Nursing and Personal Care Facilities	805	623110 and 623111

Veterinary Services	074	542940

	4(b)  Information Requested

(i)  Data Items

	In this ICR, all the data that is recorded or reported is required by State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60, subpart Ce and 40 CFR part 62, subpart HHH).

A source must make the following reports:

State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60, subpart Ce and 40 CFR part 62, subpart HHH).	Regulation Reference

Installation of CMS	60.37e, 60.56c, 60.57c, 62.14454

Initial and repeat performance specification tests for CMS	60.37e, 60.56c, 60.57c, 62.14454(f)

Initial equipment inspection (small rural HMIWI)	60.37e(b), 60.56c, 60.57c, 62.14440

Increments of progress for HMIWI that will comply with regulation 60.39e(c)

Request for extension to shut down late	60.39e(d)

Waste management plan	60.35e(a), 60.55c(c), 60.58c(c), 62.14430

Notification of HMIWI capacity	60.58c(a)

Notification of initial CMS demonstration	60.38e(a), 60.7

Report of initial CMS demonstration	60.38e(a), 60.7(c)

Notification of exemption claim for combustors burning pathological, low-level radioactive, and/or chemotherapeutic waste	60.32e(b)

Annual report containing information from annual equipment inspection, required maintenance, and repairs not completed during established time frame	60.38e(b)

Notification of exemption claim for co-fired combustors	60.32e(c)

Notification of relative weight of hospital waste, medical/infectious waste, and other fuels and/or wastes to be combusted at co-fired combustor	60.32e(c)

Notification of initial performance tests (PM, CO, fugitive emissions, stack opacity, dioxins/furans, HCl, Cd, Pb, Hg)	60.38e(a), 60.8(d)

Report on initial performance test data (PM, CO, fugitive emissions, stack opacity, dioxins/furans, HCl, Cd, Pb, Hg)	60.38e(a), 60.58c(c), 60.8(a), 62.14463(a)

Values for site-specific operating parameters	60.38e(a), 60.58c(c), 62.14463(b)

Annual report of values for site-specific operating parameters 60.38e(a), 60.58c(d), 62.14463(f)

Annual report of the highest maximum and lowest minimum operating parameters (covering the last two years)	60.38e(a), 60.58c(d), 62.14463(d)

Annual report of emissions or operating parameter exceedances, malfunctions, and periods for which data on emissions/operating parameters were not obtained (covering the last two years)	60.38e(a), 60.58c(d), 60.7(c), 62.14463(g)

Annual report containing results of annual performance test	60.38e(b), 60.58c(d), 62.14464(b)

If no excess emissions, malfunctions, or operating parameter exceedances, annual report stating so	60.38e(a) 60.58c(d), 62.14463(i)

Any use of the bypass stack, duration, reason for malfunction, and corrective action taken 	60.38e(a) 60.58c(d), 62.14463(j)

Semiannual report of emissions or operating parameter exceedances, malfunctions, and periods for which data on emissions/operating parameters were not obtained	60.38e(a) 60.58c(e), 60.7(c), 60.7(d), 62.14464(c)

Annual update of operating information	60.34(e), 60.53c(i), 62.14423(c)

Annual review of operating information with each operator	60.34(e), 60.53c(h), 62.14425(a)

A source must keep the following records:

State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60, subpart Ce and 40 CFR part 62, Subpart HHH)	Regulation Reference

5-year retention of records, related to emissions	60.38e(a), 60.58c(b), 60.58c(f), 62.14461

Records of startup, shutdown, or malfunction	60.38e(a), 60.57c, 60.7(b), 62.14460(d)

Records of initial performance test	60.37e, 60.57c, 62.14460(a)

Records of CMS operation and maintenance	60.38e(a), 60.57c, 60.7(f), 62.14460(a)

Records of annual equipment inspections, required maintenance, and repairs not completed during established timeframe	60.38e(b), 62.14460(a)

Records on a quarterly basis of periods of time when only pathological, low-level radioactive, and/or chemotherapeutical waste is burned 60.32e(b), 62.14400

Records on quarterly basis of weight of hospital waste and medical/infectious waste combusted, and weight of all other fuels and waste combusted at co-fired combustors	60.32e(c), 62.14400

Records for which data on emissions/operating parameters were not obtained	60.38e(a), 60.58c(b), 60.8(f), 62.14460(c)

Records related to malfunctions	60.38e(a), 60.58c(b), 60.8(f), 62.14460(d)

Records of emissions or operating parameter exceedances	60.38e(a), 60.58c(b), 60.8(f), 62.14460(e)

Records of initial, annual, and any subsequent performance tests 60.38e(a), 60.58c(b), 60.8(f), 62.14460(f)

Records of persons completing reviews of HMIWI operating manual (initial and annual)	60.38e(a), 60.58c(b), 62.14460(g)

Records of operators completing operator training course and qualification requirements	60.38e(a), 60.58c(b), 62.14460(h)

Records of operators who have met the qualification requirements 60.38e(a), 60.58c(b), 62.14460(i)

Records of calibration of any monitoring devices	60.38e(a), 60.58c(b), 62.14460(j)

Records of emissions, process, and control device operating parameters 60.38e(a), 60.58c(b), 60.8(f), 62.14460(a)

Electronic Reporting

	Some of the respondents are using monitoring equipment that automatically records parameter data.  Although personnel at the affected facility must still evaluate the data, internal automation has significantly reduced the burden associated with monitoring and recordkeeping at a 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

Install, calibrate, maintain, and operate CMS or continuous emission monitoring systems for continuously measuring and recording the emissions of pollutants from an affected facility

Perform initial performance test and repeat performance tests if necessary.  Use applicable reference test method.

Write the notifications and reports listed above

Develop site-specific operating parameters

Develop waste management plan

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

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

	5(a)  Agency Activities

EPA conducts 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 Air Facility System (AFS).

5(b)  Collection Methodology and Management

Following notification of startup, the reviewing authority could inspect the source to determine whether the pollution control devices are properly installed and operated.  Performance test reports are used by the Agency to discern a source(s) initial capability to comply with the emission standard.  Data and records maintained by the respondents are tabulated and published for use in compliance and enforcement programs.  The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.

Information contained in the reports is entered into the 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 its delegated Authorities can edit, store, retrieve and analyze the data.

The records required by this regulation must be retained by the owner/operator for five years.

5(c)  Small Entity Flexibility

	The majority of affected facilities are not small entities or small businesses.  However, when promulgated, the Emission Guidelines were designed to address the needs of small entities and small businesses.

	The Emission Guidelines standards and reporting requirements for co-fired combustors and for incinerators burning only pathological, low-level radioactive, and/or chemotherapeutical waste are less restrictive than those for HMIWIs.  For example, co-fired combustors and incinerators burning only pathological, low-level radioactive, and/or chemotherapeutical waste are not required to conduct performance tests.  The Emission Guidelines standards and reporting requirements for small rural HMIWI are less restrictive than those for other HMIWI.  For example, small rural HMIWI are not required to conduct an initial performance test for HCl and are required to conduct annual performance tests for opacity only.  Monitoring requirements for small rural HMIWI are also less restrictive.  Additionally, small non-rural, medium, and large HMIWI are allowed to skip annual tests and reports for PM, CO, and HCl for 2-year periods if they have demonstrated compliance for three annual tests in a row.  All of these provisions will reduce the burden on HMIWI.  The other reporting requirements have been critically reviewed and determined to be necessary for ascertaining compliance with the standards.

5(d)  Collection Schedule

The specific frequency for each information collection activity within this request is shown in Table 1: Annual Respondent Burden and Cost of the Reporting and Recordkeeping Requirements for State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60, subpart Ce and 40 CFR part 62, subpart HHH).

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 for the subparts included in this ICR.  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 average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated to be 69,067 hours (Total Labor Hours from Table 1).  These hours are based on Agency studies and background documents from the development of the regulation, Agency knowledge and experience with the part 60 and 62 regulations, 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 type of industry costs associated with the information collection activities in the subject standard(s) are both labor costs which are addressed elsewhere in this ICR and the costs associated with continuous monitoring.  The capital/startup costs are one time costs when a facility becomes subject to the regulation.  The annual operation and maintenance costs are the ongoing costs to maintain the monitor(s) and other costs such as photocopying and postage.

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

Use the following table and subsequent paragraphs only if you have capital/startup and O&M costs.

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

(A)

Continuous Monitoring Device	(B)

Capital/Startup Cost for One Respondent	(C)

Number of New Respondentsa	(D)

Total Capital/Startup Cost,

(B X C)	(E)

Annual O&M Costs for One Respondent	(F)

Number of Respondents with O&M	(G)

Total O&M,

(E X F)

Temperature, pressure, flow rate, charge rate, voltage, and pH monitors n/a	0	0	$1,800	72	$129,600

a Based on the data collected by OAQPS as part of the facility and emissions index (March 2006), the average HMIWI operates approximately 6 continuous monitoring devices.  The average cost per monitoring device is $300 per year.  Therefore, the estimate O&M cost per respondent is estimated to be $1,800.

As noted in Section 1(b), no new sources are subject to this subpart to the Emission Guidelines.  Therefore, there are no capital/startup costs for this ICR.  These costs are shown on the OMB 83-I form in block 14(a), Total annualized capital/startup costs.

The total operation and maintenance (O&M) costs for this ICR are $130,000 (Rounded).  This is the total of column G.  These costs are shown on the OMB 83-I form in block 14(b), Total annual costs (O&M).

	The total respondent costs in block 14 have been calculated as the addition of the capital/startup costs, and the annual operation and maintenance costs.  The average annual cost for capital/startup and operation and maintenance costs to industry over the next three years of the ICR is estimated to be $130,000 (Rounded).  This cost is shown on the OMB 83-I form in 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 Cost

The only costs to the Agency are those costs 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, periodic inspection of sources of emissions, and the publication and distribution of collected information.

The average annual Agency cost during the three years of the ICR is estimated to be $137,181.  This cost is based on the average hourly labor rate as follows:

	Managerial	$57.20  (GS-13, Step 5, $35.75 x 1.6)

	Technical	$42.45  (GS-12, Step 1, $26.53 x 1.6)

	Clerical	$22.96  (GS-6, Step 3, $14.35 x 1.6)

These rates are from the Office of Personnel Management (OPM) 2006 General Schedule which excludes locality rates of pay.  Details upon which this estimate is based appear in Table 2:  Average Annual EPA Resource Requirement for State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60, subpart Ce and 40 CFR part 62, subpart HHH), attached.

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

Based on our research for this ICR, on average over the next three years, approximately 72 existing respondents will be subject to the standard.  It is estimated that no new respondents per year will become subject.  The overall average number of respondents, as shown in the table below is 72 per year.  The number of respondents is calculated using the following table that 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 	(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	0	72	0	0	72

2	0	72	0	0	72

3	0	72	0	0	72

Average

	72

As shown above, the average Number of Respondents over the three year period of this ICR is 72.  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

Annual Reports	72	1	0	72

Semi-Annual Reports of Emissions/Parameter Exceedances	72	2	0	144

	Total	216

The number of Total Annual Responses is 216.  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 costs are $5,575,702.  The annual labor costs are not shown on the OMB 83-I form. Details regarding these estimates may be found in Table 1: Annual Respondent Burden and Cost of the Reporting and Recordkeeping Requirements for State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60, subpart Ce and 40 CFR part 62, subpart HHH), attached.

The total annual capital/startup and O&M costs to the regulated entities are $130,000 (Rounded).  This number is 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) Costs.

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 the attached Tables 1 and 2, respectively.

(i) Respondent Tally

The Total Hours Requested is estimated to be 69,067.  This estimate is shown on the OMB 83-I form in block 13(c).  The total annual labor costs associated with the hours requested are $5,575,702.  The annual labor costs are not shown on the OMB 83-I form.  Details regarding these estimates may be found in Table 1: Annual Respondent Burden and Cost of the Reporting and Recordkeeping Requirements for State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60, subpart Ce and 40 CFR part 62, subpart HHH).  Furthermore, the annual public reporting and recordkeeping burden for this collection of information is estimated to average 320 hours per response.

The total annual capital/startup and O&M costs to the regulated entities are estimated to be $130,000 (Rounded).  This number is 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) Costs.

(ii) The Agency Tally

The average annual Agency burden and cost over next three years is estimated to be 3,314 labor hours at a cost of $137,181.  See Table 2: Average Annual EPA Resource Requirement for State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60, subpart Ce and 40 CFR part 62, subpart HHH), attached.

6(f)  Reasons for Change in Burden

The decrease in burden from the most recently approved ICR is due to an adjustment.  The decrease in burden from the most recently approved ICR is due to a decrease in the number of sources.  Our estimate is based on a facility and emissions index of HMIWI sources developed by OAQPS.  The data in the index was collected directly from industry and updated March 2006.

The previous estimate of 189 respondents was derived from approximated state agency data.  In addition, the standard applies only to facilities which commenced construction on or before June 20, 1996.  As described above, the current estimate of 72 sources represents a source-by-source count and takes into account those sources which have shutdown.  Therefore, we have adjusted the number of respondents from 189 to 72.  The decrease in cost from $295,407 to $130,000 is due to the decrease in the number of affected sources.

6(g)  Burden Statement

The annual public reporting and recordkeeping burden for this collection of information is estimated to average 320 hours per response.  Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency.  This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; 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 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-2005-0036, 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-2005-0036, and OMB Control Number 2060-0422 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 of the Reporting and Recordkeeping Requirements for State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60, subpart Ce and 40 CFR part 62, subpart HHH)

(C)

(E)	(F)	(G)

	Person-

Technical	Management	Admin	(H)	(I)

	(A)	(B)	hours per

person-	person-	person-	Total	Total

	Person-	Number of	respondent	(D)	hours	hours	hours	hours per	Labor

	hours per	occurrences	per year	Respondents	per year	per year	per year year 	Cost,

	Burden item	occurrence	per year	(D = A x C)	per year	(F = D x E)	(G = F x 0.05)	(H = F x 0.1)	(I = E+F+G)	$

	 1.	Applications	N/A

	 2.	Surveys and studies	N/A

	 3.	Reporting requirements (HMIWI)

	A.	Read and understand rule requirements	40 	1	40 	0 	0 	0 	0 	0 	$0

B.	Required activities

--Installation of CMS	15 	1	15 	0 	0 	0 	0 	0 	$0

	--Perf. spec. tests (certif.) for CMS	8 	1	8 	0 	0 	0 	0 	0 	$0

	--Repeat perf. spec. tests (certif.) for CMS	8 	1	8 	0 	0 	0 	0 	0 	$0

	--Initial equipment inspection (small rural HMIWI)	8 	1	8 	0 	0 	0 	0  0 	$0

	--Annual update of operating information	20	1	20 	72 	1,440 	72.0	144.0 1,656.0	$133,686.72

	--Review operating information with each operator	8	2	16 	72 	1,152  57.6	115.2	1,324.8	$106,949.38

	--Annual equipment inspection (small rural HMIWI)	8 	1	8 	6 	48 	2.4 4.8	55.2	$4,456.22

C.	Create information	Incl. in 3.B.

	--Development of operating information	160	1	160 	0 	0 	0 	0 	0 	$0

D.	Gather existing information	Incl. in 3.B.

E.	Write report (HMIWI)

--Increments of progress for HMIWI that will comply

	-Control plan	24 	1	24 	0 	0 	0 	0 	0 	$0

-Notificaton of construction contracts	2 	1	2 	0 	0 	0 	0 	0 	$0

-Notification of construction commencement	2 	1	2 	0 	0 	0 	0 	0 	$0

-Notification of construction completion	2 	1	2 	0 	0 	0 	0 	0 	$0

-Notification of control plan completion	2 	1	2 	0 	0 	0 	0 	0 	$0

	--Request for extension to shut down late	12 	1	12 	0 	0 	0 	0 	0 	$0

	--Notification of initial performance test	2 	1	2 	0 	0 	0 	0 	0 	$0

	--Notification of initial CMS demonstration	2 	1	2 	0 	0 	0 	0 	0 	$0

	--Waste management plan	160	1	160 	0 	0 	0 	0 	0 	$0

	--Report of initial performance test for PM, CO, Hg,	560 	1	560 	0 	0  0 	0 	0 	$0

	dioxins/furans, & stack opacity (small rural HMIWI)

	--Report of initial performance test for PM, CO, HCl,	640 	1	640 	0 	0  0 	0 	0 	$0

	dioxins/furans, metals, & stack opacity

 (small non-rural, medium, and large HMIWI)

--Report of initial CMS demonstration	Incl. in 3.B.

	--Annual report (small non-rural, medium, and large HMIWI)

--CMS operating parameters	15 	1	15 	66 	990 	49.5	99.0	1,138.5 $91,909.62

--Emissions/parameter exceedances and periods	64 	1	64 	13.2 	844.8  42.2	84.5	971.5	$78,429.54

when emission/parameter data not obtained

	--Report of annual performance test	280 	1	280 	53 	14,840 	742.0 1,484.0	17,066.0	$1,377,715.92

--Report of no exceedances	32 	1	32 	53 	1,696 	84.8	169.6	1,950.4 $157,453.25

	--Annual report (small rural HMIWI)

	--CMS operating parameters 	15 	1	15 	6 	90 	4.5	9.0	103.5	$8,355.42

--Emissions/parameter exceedances and periods	16 	1	16 	1.2 	19.2 	1.0 1.9	22.1	$1,782.49

when emission/parameter data not obtained

	--Report of annual performance test	20 	1	20 	6 	120 	6.0	12.0	138.0 $11,140.56

--Report of no exceedances	8 	1	8 	4.8 	38.4 	1.9	3.8	44.2	$3,564.98

--Report of annual equipment inspection	Incl. in 3.B.

	--Semiannual report of emissions/parameter exceedances	32 	2	64 	13.2  845 	42.2	84.5	971.5	$78,429.54

	and periods when emission/parameter data not obtained

	(small non-rural, medium, and large HMIWI)

--Semiannual report of emissions/parameter exceedances	8 	2	16 	1.2  19.2 	1.0	1.9	22.1	$1,782.49

	and periods when emission/parameter data not obtained

	(small rural HMIWI)

(C)

(E)	(F)	(G)

	Person-

Technical	Management	Admin	(H)	(I)

	(A)	(B)	hours per

person-	person-	person-	Total	Total

	Person-	Number of	respondent	(D)	hours	hours	hours	hours per	Labor

	hours per	occurrences	per year	Respondents	per year	per year	per year year 	Cost,

	Burden item	occurrence	per year	(D = A x C)	per year	(F = D x E)	(G = F x 0.05)	(H = F x 0.1)	(I = E+F+G)	$

	 4.	Reporting requirements (co-fired combustors and pathological/

low-level radioactive/chemotherapeutic waste combustors)

A.	Read instructions	N/A

B.	Required activities	N/A

C.	Create information	N/A

D.	Gather existing information	N/A

E.	Write report

--Notification of exemption claim	2 	1	2 	0 	0 	0 	0 	0 	$0

	--Notification of relative amounts of hospital waste,	2 	1	2 	0 	0 	0  0 	0 	$0

	medical/infectious waste, and other fuels and wastes

to be combusted (co-fired combustors only)

 5.	Recordkeeping requirements (HMIWI)

	A.	Read instructions	N/A

B.	Plan activities	N/A

C.	Implement activities	N/A

D.	Develop record system	N/A

E.	Time to enter information

--Records of startup, shutdown, or malfunction	1.5	52	78.0	72	5,616  280.8	561.6	6,458.4	$521,378.21

	--Records of persons reviewing operating information	2 	2	4 	72 	288  14.4	28.8	331.2	$26,737.34

	--Records of operators completing training requirements	2 	1	2 	0 	0  0.0	0.0	0.0	$0

	--Records of operators that have been qualified	2 	1	2 	0 	0 	0.0	0.0 0.0	$0

	--Records of initial performance test	Incl. in 3.E.

	--Records of process and control device operating	1.5	52	78.0	66.0 5,148.0	257.4	514.8	5,920.2	$477,930.02

	parameters (small non-rural, medium, and large HMIWI)

--Records of CMS operation and maintenance	1.5	250	375.0	66.0	24,750.0 1,237.5	2,475.0	28,462.5	$2,297,740.50

	 (small non-rural, medium, and large HMIWI)

--Records of emissions/parameter exceedances and	1.5	52	78.0	13.2 1,029.6	51.5	103.0	1,184.0	$95,586.00

	periods when emission/parameter data not obtained

 (small non-rural, medium, and large HMIWI)

--Records of process and control device	0.5	52	26.0	6.0	156.0	7.8	15.6 179.4	$14,482.73

	operating parameters (small rural HMIWI)

--Records of CMS operation and maintenance	0.5	250	125.0	6.0	750.0	37.5 75.0	862.5	$69,628.50

	 (small rural HMIWI)

--Records of emissions/parameter exceedances and	0.5	52	26.0	1.2	31.2 1.6	3.1	35.9	$2,896.55

	periods when emission/parameter data not obtained

 (small rural HMIWI)

--Records of annual and subsequent compliance tests	Incl. in 3.E.

	--Records of annual equipment inspection	Incl. in 3.B.

G.	Time to train personnel	40 	1	40 	0 	0 	0 	0 	0 	$0

H.	Time for audits	N/A

	 6.	Recordkeeping requirements (co-fired and pathological/

	low-level radioactive/chemotherapeutic combustors)

	A.	Read instructions	N/A

B.	Plan activities	N/A

C.	Implement activities	N/A

D.	Develop record system	N/A

E.	Time to enter information

--Quarterly records of periods when only pathological,	2 	4	8	13.4	107.2 5.4	10.7	123.3	$9,952.23

	low-level radioactive, chemotherapeutic waste burned

--Quarterly records of weight of hospital waste and	2 	4	8	5.0	40.0	2.0 4.0	46.0	$3,713.52

	medical/infectious waste combusted, and weight of

all other fuels and wastes combusted (co-fired only)

	F.	Time to train personnel	N/A

G.	Time for audits	N/A

	TOTAL RESPONDENT BURDEN AND COST NATIONWIDE:

60,058 	3,003 	6,006 	69,067 	$5,575,702

	ASSUMPTIONS

	We estimate that there are 72 existing HMIWI, including approximately 6 small rural HMIWI, 2 small non-rural HMIWI, 20 medium HMIWI, and 44 large HMIWI.

	A zero value for number of respondents indicates that burden was incurred prior to the time period covered by this supporting statement.

Assume 20 percent of the 72 existing HMIWI (13.4) burn pathological, low-level radioactive, and chemotherapeutic waste; and assume 7 percent of existing HMIWI (5.0) are co-fired combustors.

Costs are based on the following hourly rates:  technical at $83.71, management at $97.46, and administrative at $42.55.

	Assume 8 hour for performance test of CMS.

	Assume 8 hours for equipment inspection.

	Assume 20 hours to update the operating information each year.

Assume 8 hours to review the operating information with each operator.

	Assume 2 operators per facility.  Also assume there is no operator turnover at the affected facilities.

	Assume 160 hours for each facility to develop the operating information.

	Assume that 5 percent of HMIWI that shut down will request an extension to shut down after the first compliance date (3 years after promulgation of the Emission Guidelines).

Assume 160 hours for each facility to develop the waste management plan.

	Assume 40 hours for each facility to review the report of the initial performance test.

Assume 15 hours for incorporating operating hours into annual report.

	Assume 16 and 8 person-hours per report per pollutant to report monitoring exceedances and no excess emissions, respectively.

	For small rural HMIWI, assume 8 hours to review report of annual stack opacity compliance test.

	For small non-rural, medium, and large HMIWI assume 40 hours to review report of annual stack opacity compliance test.

	Assume 20 percent of respondents can take advantage of annual skip testing (forgo annual testing because passed previous 3 tests).

Assume 20 percent of respondents report monitoring exceedances.

For small rural HMIWI, assume 0.5 hours per week to record process and control device operating parameters and to record any exceedances of these parameters.

For small non-rural, medium, and large HMIWI assume 1.5 hours per week to record operating parameters and parameter exceedances.

Assume 1 hour for recording CMS operation and maintenance records; assume an average HMIWI operates 250 days per year.

	The labor requirements to train the personnel were estimated to be 8 hours per day for 5 days per year.

	Table 2.  Average Annual EPA Resource Requirement for State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60, subpart Ce and 40 CFR part 62, subpart HHH)

	(C)

(E)	(F)	(G)	(H)

(A)	(B)	EPA-hours

Technical	Management	Admin	Total	(I)

	EPA-hours	Number of	per facility	(D)	person-hours	person-hours person-hours	hours	Total

	per	occurrences	per year	Facilities	per year	per year	per year	per year Cost,

	Burden Item	occurrence	per year	(C = A x B)	per year	(E = C x D)	(F = E x 0.05)	(G = E x 0.1)	(E)+(F)+(G)	$

	 1.	Attend initial performance test	32	1	32	0	0	0	0	0	0

	 2.	Repeat performance test

	A.	Retesting preparation	12	1	12	0	0	0	0	0	0

B.	Attend retesting	32	1	32	0	0	0	0	0	0

	 3.	Report review

	A.	Review reports for co-fired combustors

--Review notification of exemption claim	2	1	2	0	0	0	0	0	0

	--Review notification of relative amounts of hospital	2	1	2	0	0	0	0	0	0

	waste, medical/infectious waste, and other fuels and

	wastes to be combusted

	B.	Review notification of exemption claim for pathological,	2	1	2	0	0	0 0	0	0

	low-level radioactive, chemotherapeutic combustors

C.	Review reports of increments of progress

--Review control plan	4	1	4	0	0	0	0	0	0

	--Review notification of construction contracts	2	1	2	0	0	0	0	0	0

	--Review notification of construction commencement	2	1	2	0	0	0	0	0	0

	--Review notification of construction completion	2	1	2	0	0	0	0	0	0

	--Review notification of control plan completion	2	1	2	0	0	0	0	0	0

D. 	Review request for extension for HMIWI planning to shut	4	1	4	0	0	0 0	0	0

	down late

	E.	Review reports for small non-rural, medium and large

	HMIWI

--Review waste management plan	8	1	8	0	0	0	0	0	0

	--Review notification of initial performance test	8	1	8	0	0	0	0	0	0

	--Review notification of initial CMS demonstration	5	1	5	0	0	0	0	0	0

	--Review report of initial performance test	36	1	36	0	0	0	0	0	0

	--Review report of initial CMS demonstration	24	1	24	0	0	0	0	0	0

	--Review annual report

	--CMS operating parameters	6	1	6	66	396	19.8	39.6	455	$18,851.98

--Emissions/parameter exceedances and periods	16	1	16	13.2	211.2	10.6 21.1	243	$10,054.39

when emission/parameter data not obtained

--Results of annual performance test	24	1	24	66	1584	79.2	158.4	1,822 $75,407.90

--Report of no exceedances	8	1	8	53	424	21.2	42.4	488	$20,184.94

	--Review semiannual report of emissions/parameter	8	1	8	13.2	105.6	5.3 10.6	121	$5,027.19

	exceedances and periods when emission/parameter

	data not obtained

	F.	Review reports for small rural HMIWI

--Review waste management plan	8	1	8	0	0	0	0	0	0

	--Review notification of initial performance test	8	1	8	0	0	0	0	0	0

	--Review notification of initial CMS demonstration	5	1	5	0	0	0	0	0	0

	--Review report of initial performance test	30	1	30	0	0	0	0	0	0

	--Review report of initial CMS demonstration	8	1	8	0	0	0	0	0	0

	--Review annual report

	--CMS operating parameters	2	1	2	6	12	0.6	1.2	14	$571.27

--Emissions/parameter exceedances and periods	4	1	4	1.2	4.8	0.2	0.5	6 $228.51

when emission/parameter data not obtained

--Results of annual performance test	6	1	6	6	36	1.8	3.6	41	$1,713.82

--Report of no exceedances	2	1	2	4.8	9.6	0.5	1.0	11	$457.02

--Report of annual equipment inspection	4	1	4	6	24	1.2	2.4	28	$1,142.54

	(C)

(E)	(F)	(G)	(H)

(A)	(B)	EPA-hours

Technical	Management	Admin	Total	(I)

	EPA-hours	Number of	per facility	(D)	person-hours	person-hours person-hours	hours	Total

	per	occurrences	per year	Facilities	per year	per year	per year	per year Cost,

	Burden Item	occurrence	per year	(C = A x B)	per year	(E = C x D)	(F = E x 0.05)	(G = E x 0.1)	(E)+(F)+(G)	$

	--Review semiannual report of emissions/parameter	2	1	2	1.2	2.4	0.1	0.2 3	$114.25

	exceedances and periods when emission/parameter

	data not obtained

	4	Prepare annual summary report	1	1	1	72	72	3.6	7.2	83	$3,427.63

	TOTAL DESIGNATED ADMINISTRATOR BURDEN AND COST

2,882 	144 	288 	3,314	$137,181

ASSUMPTIONS

	We estimate that there are 72 existing HMIWI, including approximately 6 small rural HMIWI, 2 small non-rural HMIWI, 20 medium HMIWI, and 44 large HMIWI.

	A zero value for number of respondents indicates that burden was incurred prior to the time period covered by this supporting statement.

Costs are based on the following hourly rates:  technical at $42.45, management at $57.20, and administrative at $22.96.

	Of the 20 percent (13.2 for small non-rural, medium, and large HMIWI; 1.2 for small rural) reported parameter exceedances

	Assume 8 hours to review the waste management plan prepared by each of the affected facilities.

	Assume 2 hours for review of notifications for increments of progress.

	Assume 4 hours for review of control plan.

	Assume 4 hours for review of request for extension.

	Assume 8 to review notification of initial performance test and CMS demonstration

Assume 5 hours to review notification of initial CMS demonstration

	Assume 36 hours to review initial performance test (30 hours for small rural HMIWI)

Assume 24 hours to review initial CMS demonstration (8 hours for small rural HMIWI).

Assume 54 hours to review annual reports for small non-rural, medium and large HMIWI.

Assume 18 hours to review annual reports for small rural HMIWI.

Assume 2 hours review emissions and parameter exceedances for the semi-annual report.

Assume 1 hour per facility when preparing the annual source and emissions inventory update.

 PAGE

 PAGE  30


[Federal Register: November 28, 2007 (Volume 72, Number 228)]
[Rules and Regulations]
[Page 67242-67245]
[DOCID:fr28no07-6]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-26966; Directorate Identifier 99-NE-01-AD;
Amendment 39-15271; AD 2007-24-05]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce Corporation AE 3007A and AE
3007C Series Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: The FAA is superseding an existing airworthiness directive
(AD) for Rolls-Royce Corporation (RRC) AE 3007A and AE 3007C series
turbofan engines. That AD currently prohibits any flight following a
ground engine start where the engine oil temperature is below 32 [deg]F
(0 [deg]C), unless certain preflight operational procedures are
followed. This AD also requires those actions and would also require a
terminating action. This AD results from design improvements to
components in the accessory gearbox air turbine starter mounting pad.
We are issuing this AD to prevent an in-flight engine shutdown due to
loss of engine oil from the engine accessory gearbox starter pad shaft
seal drain and possible loss of the airplane.

DATES: This AD becomes effective January 2, 2008. The Director of the
Federal Register approved the incorporation by reference of certain
publications listed in the regulations as of January 2, 2008.

ADDRESSES: You can get the service information identified in this AD
from Rolls-Royce Corporation, P.O. Box 420, Indianapolis, IN 46206;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>    The Docket Operations office is located at Docket Management
Facility, U.S. Department of Transportation, 1200 New Jersey Avenue,
SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-
0001.

FOR FURTHER INFORMATION CONTACT: Kyri Zaroyiannis, Aerospace Engineer,
Chicago Aircraft Certification Office, Small Airplane Directorate, FAA,
2300 E. Devon Ave., Des Plaines, IL 60018; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The FAA proposed to amend 14 CFR part 39 by
superseding AD 99-02-51, Amendment 39-11108 (64 FR 16339, April 5,
1999), with a proposed AD. The proposed AD applies to RRC AE 3007A and
AE 3007C series turbofan engines. We published the proposed AD in the
Federal Register on March 29, 2007 (72 FR 14724). That action proposed
to:
     Prohibit before further flight, any flight following a
ground engine start where the engine oil temperature is below 32 [deg]F
(0 [deg]C), unless certain preflight operational procedures are
followed to ensure that there is no excessive loss of oil from leakage
at the air turbine starter shaft; and
     Require terminating action to the prohibition requirements
of the existing AD, by removing from service certain seal P/Ns from the
accessory gearbox air turbine starter mounting pad and installing an
improved seal; and
     Require removing certain P/N drain caps, drain adapters,
and orifice inserts, and installing an open adapter on the starter pad
drain.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is provided in
the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

Comments

    We provided the public the opportunity to participate in the

development of this AD. We have considered the comments received.

Request To Continue To Allow Existing Approved AMOCs

    Four commenters, ExpressJet Inc., RRC, Embraer, and Cessna Aircraft
Company state that alternative methods of compliance (AMOCs) currently
approved for AD 99-02-51 should be allowed while this AD is not
incorporated or until September 30, 2009. Paragraph (l) of the proposed
rule states that AMOCs approved for AD 99-02-51 are not approved for
the new rule. Until all engines are modified as required by paragraph
(g) of the proposed rule, an aircraft may encounter 32 [deg]F
temperature or lower and it seems arbitrary to disallow the use of data
that has already been approved and in use for over two years. Operators
would have the burden of requesting the same AMOC for the superseding
AD. Allowing the currently approved AMOCs would bridge the time gap to
the Terminating Action compliance date.
    We agree. We changed Alternative Methods of Compliance (AMOC),
paragraph (l) from ``AMOCs approved for AD 99-02-51 are not approved as
AMOCs for this AD.'' to ``AMOCs currently approved for AD 99-02-51 will
remain in effect until the terminating action date for this AD,
September 30, 2009. After that date, these AMOCs will expire and not be
approved as AMOCs for this AD.'' This change will avoid confusion in
the field and the AMOCs are still appropriate for the period before the
mandatory terminating action date. These AMOCs will expire permanently
on September 30, 2009, after which the only allowable configuration
option is the new seal, a compatible starter and an open seal drain.

Request To Provide a More Accurate Description of the Original Problem

    Two commenters, RRC and Embraer, ask us to include a more accurate
description of the original problem. They state that the nomenclature
``Starter shaft seal'' may cause confusion with the seal of the
pneumatic Air Turbine Starter (ATS). We agree. We changed Unsafe
Condition, paragraph (d) from ``* * * due to loss of engine oil from
the starter shaft seal'' to ``* * * due to loss of engine oil from the
engine accessory gearbox starter pad shaft seal drain and possible loss
of the airplane.''

Request To Clarify the Regulatory Text

    Rolls-Royce Corporation asks us to make the following changes for
clarity:
     Prohibited Flights, paragraph (f)(2): Change ``Oil
consumption greater than 0.32 quart per hour (303 cc per hour) * * *''
to ``Oil consumption greater than 0.32 quart per hour, or 300 cc per
hour, * * *'' Although it may not be a completely accurate quart-to-cc
conversion, 300 cc is the value listed in all RRC manuals.
     Terminating Action, paragraph (g): Change ``* * * do the
following, as applicable to your engine model and configuration.'' to
``* * * do the following, as applicable to your configuration.'' Engine
model applicability is already established so it can be deleted here to
make a simpler statement.
     Terminating Action, paragraph (g)(1): Change ``Remove seal
part number (P/N) * * * '' to ``Remove seal and related component part
numbers (P/Ns) * * *'' The P/Ns listed are not only currently approved
seals but also adjacent hardware including a wave spring and spacer
used in one of the approved configurations. This change accounts for
all current hardware, not just the seals.
     Terminating Action, paragraph (g)(2): Change ``Install a
new seal, P/N AS3209-026 * * *'' to ``Install a new O-ring, P/N AS3209-
026 or M83248/1-026* * *'' RRC lists both of these P/Ns as acceptable
alternatives in the engine parts list. Also, the correct nomenclature
is O-ring, not seal.
     Prohibition of Seals, paragraph (i): Change ``Once the
terminating action in this AD is performed on an engine, seal P/Ns * *
*'' to ``Once the terminating action in this AD is performed on an
engine, seal and related component P/Ns * * *'' This change accounts
for all current hardware, not just the seals.
    We agree with the suggestions and incorporated them into the
applicable regulatory text of the AD.

Request to Not Implement the AD

    Rolls-Royce North America, Inc., c/o American Eagle Airlines, asks
us to not implement the AD, or at least extend the required completion
date for the terminating action by at least 6-12 months. They believe
that many AE3007A and AE3007C engines are not yet compliant with RRC
Service Bulletin AE 3007A-72-321 and or SB AE 3007A-72-330. They state
that it would be too much of a burden to modify all of the engines
currently out in the field to be compliant with the proposed AD by
September 30, 2009. A drastic maintenance campaign such as this would
adversely affect the AE3007A and C fleet both in terms of costs and
operations to drastic proportions.
    We don't agree. We have determined that we can better assure long-
term continued operational safety by design changes that remove the
source of the problem, rather than by repetitive inspections or other
special procedures. Based on the availability of the required parts and
the support from the vast majority of operators and their ability to
comply within the original specified date, we believe this is a
reasonable time period and will maintain the final compliance date of
September 30, 2009.

Conclusion

    We have carefully reviewed the available data, including the
comments received, and determined that air safety and the public
interest require adopting the AD with the changes described previously.
We have determined that these changes will neither increase the
economic burden on any operator nor increase the scope of the AD.

Costs of Compliance

    We estimate that this AD will affect 1,868 RRC AE 3007A and AE
3007C series turbofan engines installed on aircraft of U.S. registry.
We also estimate that it will take about 4 work-hours per engine to
perform the proposed terminating action, and that the average labor
rate is $80 per work-hour. Required parts will cost about $2,917 per
engine. Based on these figures, if all engines incorporated the
terminating action, we estimate the total cost of this AD to U.S.
operators to be $6,046,100.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
subtitle VII, part A, subpart III, section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will

not have a substantial direct effect on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979); and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a summary of the costs to comply with this AD and
placed it in the AD Docket. You may get a copy of this summary at the
address listed under ADDRESSES.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the Federal Aviation Administration amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Amendment 39-11108 64 FR
16339 April 5, 1999, and by adding a new airworthiness directive,
Amendment 39-15271, to read as follows:

2007-24-05 Rolls-Royce Corporation (Formerly Allison Engine Company,
Inc.): Amendment 39-15271. Docket No. FAA-2007-26966; Directorate
Identifier 99-NE-01-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective January
2, 2008.

Affected ADs

    (b) This AD supersedes AD 99-02-51, Amendment 39-11108.

Applicability

    (c) This AD applies to Rolls-Royce Corporation (RRC) (formerly
Allison Engine Company, Inc.) AE 3007A and AE 3007C series turbofan
engines. These engines are installed on, but not limited to, Cessna
Aircraft Company 750 series, and Empresa Brasileira de Aeronautica
S. A. (EMBRAER) EMB-135 and EMB-145 series airplanes.

Unsafe Condition

    (d) This AD results from design improvements to components in
the accessory gearbox air turbine starter mounting pad. We are
issuing this AD to prevent an in-flight engine shutdown due to loss
of engine oil from the starter shaft seal and possible loss of the
airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified unless the
actions have already been done.

Prohibited Flights

    (f) All flights after ground engine starts at engine oil
temperatures below 32 [deg]F (0 [deg]C), are prohibited except as
follows:
    (1) If the engine oil temperature has dropped below 32 [deg]F (0
[deg]C), before flight, perform a high-power leak check on each
engine (at least three minutes at takeoff power).
    (2) Oil consumption greater than 0.32 quart per hour, or 300 cc
per hour, is not permitted. Instructions for performing the high-
power leak check for the AE 3007A series engines can be found in the
Rolls-Royce AE 3007A Series Maintenance Manual, TASK 72-00-00-700-
801, SUBTASK 72-00-00-790-002. Leak check limits for the AE 3007A
series engines can be found in the Rolls-Royce AE 3007A Series
Maintenance Manual, TASK 71-00-00-200-801.
    (3) Instructions for performing the high-power leak check for
the AE 3007C series engines (including leak check limits) can be
found in the Rolls-Royce AE 3007C Series Maintenance Manual, TASK
72-00-00-700-801, SUBTASK 72-00-00-790-002.

Terminating Action

    (g) No later than September 30, 2009, as terminating action to
the requirements in paragraph (f) through (f)(3) of this AD, do the
following, as applicable to your engine configuration:
    (1) Remove seal and related component, part numbers (P/Ns)
42520-71, 42520-196-X, 99004-1-6, 42520-75, or 42520-167, from the
accessory gearbox (AGB) air turbine starter mounting pad.
    (2) Install a new O-ring, P/N AS3209-026, M83248/1-026 or other
serviceable part, to the shaft of the starter mounting pad.
    (3) Install a new bearing locknut, P/N 42520-170, or other
serviceable part, and an AGB air turbine starter mounting pad
mechanical seal, P/N 42520-192, or other serviceable part.
    (4) Use paragraphs 2. through 2.G. of the Accomplishment
Instructions of RRC Service Bulletin (SB) No. AE 3007A-72-321/AE
3007C-72-250, Revision 2, dated November 12, 2007, to do the
removals and installations.
    (5) For AE 3007A series engines, remove the drain cap or starter
drain adapter. Use paragraphs 2. through 2.C.(4)(c) of the
Accomplishment Instructions of RRC SB No. AE 3007A-72-274, Revision
1, dated November 12, 2007 to do the removal.
    (6) For AE 3007A series engines, install an open starter drain
adapter. Use paragraphs 2. through 2.C.(2) of the Accomplishment
Instructions of RRC SB No. AE 3007A-72-330, Revision 1, dated
November 12, 2007 to do the installation.
    (7) For AE 3007C series engines, install an open starter drain
adapter. Use paragraphs 2. through 2.E.(2) of the Accomplishment
Instructions of RRC SB No. AE 3007C-72-223, Revision 1, dated
November 12, 2007 to do the installation.

Definition

    (h) A serviceable part is any FAA-approved part not being
removed from service, or not otherwise specifically addressed by
this AD action.

Prohibition of Seals

    (i) Do not install seal and related component P/Ns 42520-71,
42520-196-X, 99004-1-6, 42520-75, and 42520-167, on the air starter
mounting pad after the terminating action in this AD is performed.

Previous Credit

    (j) Previous credit is allowed for the terminating action in
paragraphs (g)(1) through (g)(7) of this AD, that was done before
the effective date of this AD using the Accomplishment Instructions
of the SBs listed in the following Table 1:

                 Table 1.--SBs Allowing Previous Credit
------------------------------------------------------------------------

-------------------------------------------------------------------------
For AE 3007A Series Engines:
    (1) Engine--Accessory Drive Gearbox Assembly--New Starter Shaft
     Seal; RRC SB No. AE 3007A-72-321/AE 3007C-72-250, Revision 1, dated
     November 7, 2005; and
    (2) Engine--Accessory Gearbox Starter Pad Drain--Remove The Drain
     Cap or Starter Drain Adapter; RRC SB No. AE 3007A-72-274, dated
     January 19, 2006; and
    (3) Engine--Accessory Gearbox Starter Pad Drain--Install the Open
     Starter Drain Adapter (23083402 or 23077526); RRC SB No. AE 3007A-
     72-330, dated January 19, 2006.
For AE 3007C Series Engines:
    (4) Engine--Accessory Drive Gearbox Assembly--New Starter Shaft
     Seal; RRC SB No. AE 3007A-72-321/AE 3007C-72-250, Revision 1, dated
     November 7, 2005; and

    (5) Engine--Accessory Gearbox Starter Pad Drain--Install the Open
     Starter Drain Adapter (23077526 or 23083403); RRC SB No. AE 3007C-
     72-223, dated January 19, 2006.
------------------------------------------------------------------------

Alternative Methods of Compliance (AMOC)

    (k) The Manager, Chicago Aircraft Certification Office, has the
authority to approve AMOCs for this AD if requested using the
procedures found in 14 CFR 39.19.
    (l) AMOCs currently approved for AD 99-02-51 will remain in
effect until the terminating action date for this AD, September 30,
2009. After that date, these AMOCs will expire and will not be
approved as AMOCs for this AD.

Related Information

    (m) Contact Kyri Zaroyiannis, Aerospace Engineer, Chicago
Aircraft Certification Office, Small Airplane Directorate, FAA, 2300
E. Devon Ave., Des Plaines, IL 60018; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax (847) 294-
7834, for more information about this AD.

Material Incorporated by Reference

    (n) You must use the service information specified in Table 2 to
perform the actions required by this AD. The Director of the Federal
Register approved the incorporation by reference of the documents
listed in Table 2 of this AD in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. Contact Rolls-Royce Corporation, P.O. Box 420,
Indianapolis, IN 46206; telephone<PHONE_NUMBER>; fax (317) 230-
8084; e-mail<EMAIL_ADDRESS>for a copy of this
service information. You may review copies at the FAA, New England
Region, 12 New England Executive Park, Burlington, MA; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>, or
go to: http://www.archives.gov/federal-register/cfr/ibr-
locations.html.

                                      Table 2.--Incorporation by Reference
----------------------------------------------------------------------------------------------------------------
      Service Bulletin No.                     Page                  Revision                  Date
----------------------------------------------------------------------------------------------------------------
AE 3007A-72-274.................  ALL...........................               1  November 12, 2007.
    Total Pages--6
AE 3007A-72-321, AE 3007C-72-250  ALL...........................               2  November 12, 2007.
    Total Pages--13
AE 3007A-72-330.................  ALL...........................               1  November 12, 2007.
    Total Pages--6
AE 3007C-72-223.................  ALL...........................               1  November 12, 2007.
  Total Pages--7
----------------------------------------------------------------------------------------------------------------

    Issued in Burlington, Massachusetts, on November 14, 2007.
Peter A. White,
Acting Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
 [FR Doc. E7-22810 Filed 11-27-07; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 58 (Tuesday, March 26, 2019)]
[Notices]
[Page 11385]
[FR Doc No: 2019-05810]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: 2:00 p.m. on Thursday, March 28, 2019.

PLACE: The meeting will be held at the Commission's headquarters, 100 F
Street NE, Washington, DC 20549.

STATUS: This meeting will be closed to the public.

MATTERS TO BE CONSIDERED: Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    Commissioner Roisman, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matters of the closed meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Litigation matters; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.

CONTACT PERSON FOR MORE INFORMATION: For further information and to
ascertain what, if any, matters have been added, deleted or postponed;
please contact Vanessa A. Countryman from the Office of the Secretary
at<PHONE_NUMBER>.

    Dated: March 21, 2019.
Vanessa A. Countryman,
Acting Secretary.
[FR Doc. 2019-05810 Filed 3-22-19; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 151 (Thursday, August 6, 2015)]
[Notices]
[Pages 46990-46993]
[FR Doc No: 2015-19244]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-D-0500] (formerly Docket No. 2004D-0042)

Brief Summary and Adequate Directions for Use: Disclosing Risk
Information in Consumer-Directed Print Advertisements and Promotional
Labeling for Prescription Drugs; Revised Draft Guidance for Industry
(Revision 2); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
reissuance of a revised draft guidance for industry (Revision 2)
entitled ``Brief Summary and Adequate Directions for Use: Disclosing
Risk Information in Consumer-Directed Print Advertisements and
Promotional Labeling for Prescription Drugs.'' We are reissuing the
revised draft guidance to incorporate animal prescription drugs. This
reissued revised draft guidance, when finalized, will assist
manufacturers, packers, and distributors (firms) of human prescription
drugs, including biologics, and animal prescription drugs, with meeting
the brief summary requirement for prescription drug advertising and the
requirement that adequate directions for use be included with
promotional labeling for prescription drugs when print materials are
directed toward consumers.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this reissued revised draft guidance before it

begins work on the final version of the guidance, submit either
electronic or written comments on the reissued revised draft guidance
by October 5, 2015. Submit either electronic or written comments on the
proposed collection of information by October 5, 2015.

ADDRESSES: Submit written requests for single copies of the reissued
revised draft guidance to the Division of Drug Information, Center for
Drug Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave. Hillandale Building, 4th Floor, Silver Spring, MD 20993-
0002; to the Office of Communication, Outreach and Development, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002; or 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 request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the revised draft guidance
document.
    Submit electronic comments on the reissued revised draft guidance
to http://www.regulations.gov. Submit written comments to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Regarding human prescription drugs:
Julie Chronis, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD
20993-0002,<PHONE_NUMBER>. Regarding human prescription biological
products: Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>. Regarding animal
prescription drugs: Thomas Moskal, Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl. Rockville, MD 20855-2792,
240-402-6251.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the reissuance of a revised draft guidance for
industry entitled ``Brief Summary and Adequate Directions for Use:
Disclosing Risk Information in Consumer-Directed Print Advertisements
and Promotional Labeling for Prescription Drugs.'' We are reissuing the
revised draft guidance to incorporate animal prescription drugs; there
are no other revisions to the revised draft guidance for industry
issued February 9, 2015 (80 FR 6998).
    As stated previously, the revised draft guidance updates prior FDA
policy and describes the Agency's current thinking regarding the brief
summary requirement for consumer-directed print prescription drug
advertisements. Specifically, the revised draft guidance includes
recommendations for developing a consumer brief summary and notes that,
so long as firms include appropriate information in a print
advertisement as outlined in the revised draft guidance, FDA does not
intend to object for a failure to include certain other information.
    Additionally, the revised draft guidance provides new
recommendations regarding the adequate directions for use requirement
for consumer-directed print promotional labeling for prescription drug
products. Although the requirement in 21 CFR 201.100(d) and 21 CFR
201.105(d) for firms to provide adequate information for use is
generally fulfilled by providing the full FDA-approved package insert
(PI), the revised draft guidance provides that, in exercising its
enforcement discretion, FDA does not intend to object for failure to
include the full PI with consumer-directed print promotional labeling
pieces if firms include the appropriate information as outlined in the
revised draft guidance, i.e., the same information in the consumer
brief summary. This recommendation is designed to standardize the
information consumers receive in print prescription drug product
advertisements and promotional labeling and to make information more
understandable to consumers.
    FDA issued a draft guidance in the Federal Register of February 10,
2004 (69 FR 6308), entitled ``Brief Summary: Disclosing Risk
Information in Consumer-Directed Print Advertisements.'' FDA requested
comments on whether the draft guidance provided sufficient guidance on
the content of the consumer brief summary and also requested research
results on potential formats for the consumer brief summary. Comments,
suggestions, and research were submitted to Docket No. 2004D-0042 and
were carefully analyzed and considered before developing the revised
draft guidance.
    FDA issued the revised draft guidance in the Federal Register of
February 9, 2015, giving interested parties an opportunity to submit
comments by May 11, 2015. We are reissuing the revised draft guidance
to incorporate animal prescription drugs; there are no other revisions
to the revised draft guidance issued February 2015.
    The revised draft guidance incorporates information from recent
social science research, clarifies the risk information that should be
included in the consumer brief summary, and recommends several
formatting options for this information. The revised draft guidance
also recommends the use of consumer-friendly language and visual
techniques to improve accessibility for consumers. Additionally, the
revised draft guidance recommends that firms not disseminate the full
PI to fulfill the requirements in Sec.  201.100(d) for consumer-
directed print promotional labeling for prescription drugs. Rather, the
revised draft guidance recommends that firms provide the same content
and format created for the consumer brief summary. FDA is issuing the
revised guidance as a draft to allow for public comment on the
recommendations.
    The reissued revised draft guidance is being issued consistent with
FDA's good guidance practices regulations (21 CFR 10.115). The reissued
revised draft guidance, when finalized, will represent FDA's current
thinking on the brief summary and adequate directions for use
requirements. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document. The
revised draft guidance also refers to previously approved collection of
information found in FDA regulations.

    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Brief Summary and Adequate Directions for Use: Disclosing
Risk Information in Consumer-Directed Print Advertisements and
Promotional Labeling for Prescription Drugs.
    Description of Respondents: Respondents to this collection of
information are manufacturers, packers, and distributors (firms) of
human and animal prescription drug products, including biological
products for use in humans.
    Burden Estimate: The reissued revised draft guidance pertains to
the brief summary requirement for prescription drug advertising and the
requirement that adequate directions for use be included with
promotional labeling for human and animal prescription drugs when print
materials are directed toward consumers.
    The reissued revised draft guidance, in part, explains FDA's
current policy position that FDA does not intend to object for failure
to include the entire PI to fulfill the requirements of Sec. Sec.
201.100(d) and 201.105(d)(1) for promotional labeling pieces directed
toward consumers, if firms instead provide information on the most
serious and the most common risks associated with the product, while
omitting less important information. Specifically, FDA recommends that
any Boxed Warning, all Contraindications, certain information regarding
Warnings and Precautions (i.e., the most clinically significant
information from the Warnings and Precautions section of the PI,
information that would affect a decision to prescribe or take a drug,
monitoring or laboratory tests that may be needed, special precautions
not set forth in other parts of the PI, and measures that can be taken
to prevent or mitigate harm), and the most frequently occurring Adverse
Reactions should be included.
    Furthermore, FDA recommends that information should include the
indication for the use being promoted. Information regarding patient
directives (such as ``discuss with your health care provider any pre-
existing conditions'' or ``tell your health care provider if you are
taking any medications'') should also be included. Other types of
information may be included if relevant to the drug or specific
indication referred to in the promotional material(s). A statement
should be included that more comprehensive information can be obtained
from various sources, including the firm.
    Thus, the reissued revised draft guidance recommends that firms
disclose certain information to others in place of the PI to fulfill
the requirements in Sec. Sec.  201.100(d) and 201.105(d). This ``third-
party disclosure'' constitutes a ``collection of information'' under
the PRA.
    FDA estimates that approximately 400 firms subject to Sec.
201.100(d) disseminate 24,000 consumer-directed print promotional
labeling pieces annually. FDA estimates that approximately 40 firms
subject to Sec.  201.105(d) disseminate 2,000 consumer-directed print
promotional labeling pieces annually. FDA estimates that it will take
firms approximately 10 hours to compile and draft the information
needed to provide the information recommended in the revised draft
guidance. Please note that the requirements related to print
advertising pieces and the associated burden is already accounted for
under the requirements under 21 CFR 202.1 and its approved information
collection OMB control number 0910-0686 and, therefore, is not included
in the burden estimate reported in table 1.

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
  Adequate information for use:
 Disclosing risk information in      Number of       Number of     Total annual      Hours per
  consumer-directed promotional     respondents     disclosures     disclosures     disclosure      Total hours
            labeling                              per respondent
----------------------------------------------------------------------------------------------------------------
Disclosures Related to Adequate              400              60          24,000              10         240,000
 Information for Use (Sec.
 201.100(d))....................
Disclosures Related to Adequate               40              50           2,000              10          20,000
 Information for Use (Sec.
 201.105(d))....................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    This reissued revised draft guidance also refers to previously
approved collections of information found in FDA regulations with
respect to the brief summary requirement for print advertisements.
These collections of information are subject to review by OMB under the
PRA. The collection of information in Sec.  202.1 has been approved
under OMB control number 0910-0686.

III. Comments

    In addition to general comments, FDA specifically requests comments
on the following issues:
     In the revised draft guidance, FDA provides
recommendations regarding the content and format of the consumer brief
summary. Is this the most useful information for consumers to use in
determining whether to take a medication or seek more information about
a product, and if not, what information would be more useful?
     FDA is also interested in relevant research that has been
conducted or alternative formats that were developed after we received
comments on the 2004 draft guidance.
     In the revised draft guidance, FDA suggests that the
adequate directions for use requirement be fulfilled by providing the
consumer brief summary rather than the full PI for the product. FDA
seeks comments regarding this recommendation.
    Persons who commented on the version of the revised draft guidance
issued in February 2015 do not need to resubmit their comments. When
finalizing the revised draft guidance, we will review comments received
on this reissued version, as well as the version issued February 2015.
    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It

is only necessary to send one set of comments. Identify comments with
the docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or http://www.regulations.gov.

    Dated: July 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19244 Filed 8-5-15; 8:45 am]
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[Federal Register: May 8, 2008 (Volume 73, Number 90)]
[Notices]
[Page 26119]
[DOCID:fr08my08-90]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0063] (formerly Docket No. 2008N-0016)

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Exports: Notification
and Recordkeeping Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Fax written comments on the collection of information by June 9,
2008.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All comments
should be identified with the OMB control number 0910-0482. Also
include the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Exports: Notification and Recordkeeping Requirements--(OMB Control
Number 0910-0482)--Extension

    The respondents to this information collection are exporters who
have notified FDA of their intent to export unapproved products that
may not be sold or marketed in the United States as allowed under
section 801(e) of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 381(e)). In general, the notification identifies the product
being exported (e.g. name, description, and in some cases, country of
destination) and specifies where the notification should be sent. These
notifications are sent only for an initial export; subsequent exports
of the same product to the same destination (or, in the case of certain
countries identified in section 802(b) of the act (21 U.S.C. 382(b)),
to any of those countries would not result in a notification to FDA.
    The recordkeepers to this information collection are exporters who
export human drugs, biologics, devices, animal drugs, foods and
cosmetics that may not be sold in the United States to maintain records
demonstrating their compliance with the requirements in section
801(e)(1) of the act.
    The total burden estimate of 39,120 is based on the number of
notifications received by the relevant FDA centers in fiscal year 2007,
or the last year the figures were available.
    In the Federal Register of January 28, 2008 (73 FR 4874), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
1.101(d) and (e)                 400                  3              1,200                 15             18,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                                       Annual Frequency
  21 CFR Section         No. of              per            Total Annual    Hours per  Record     Total Hours
                     Recordkeepers      Recordkeeping         Records
----------------------------------------------------------------------------------------------------------------
1.101(b) and (c)                 320                  3                960                 22             21,120
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: May 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-10204 Filed 5-7-08; 8:45 am]

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