EPA United States Environmental Protection Agency Office of Air and Radiation Office of Air Quality Planning and Standards Innovative Strategies and Economics Group Operating Permits Group August, 2000 INFORMATION COLLECTION REQUEST FOR PART 71 FEDERAL OPERATING PERMIT REGULATIONS prepared by Daniel Charles Mussatti, Senior Economist Innovative Strategies and Economics Group Air Quality Strategies and Standards Division and A. Scott Voorhees, Environmental Scientist Operating Permits Group Information Transfer and Program Integration Division EPA # 1713.04 E 1 Executive Summary Title V of the Clean Air Act requires States to develop, administer and enforce operating permit programs that comply with title V and requires EPA to stand ready to issue Federal operating permits when States fail to perform this duty. The part 71 program is a Federal operating permits program for these unapproved areas, as well as for sources located in Indian Country and Outer Continental Shelf sources. For any existing rule,

§ 3507( g) of the Paperwork Reduction Act limits how long a Director may approve a collection of information to 3 years. On May 31, 1997, OMB approved the ICR for part 71 ( OMB number 2060 0336, EPA tracking number 1713.03). That ICR was due to expire on May 31, 2000, and was granted an Emergency Extension until October 31, 2000. This ICR is a renewal of the May 31, 1997 ICR.

TABLE E 1 BURDEN CHANGE FROM 1997 ICR TO CURRENT ICR ( in hours)

Average Annual Burden in 1997 ICR Average Annual Burden in ICR Renewal Difference Indian Country Sources 677,719 15,323 ( 652,396)

Federal 499,853 74,329 ( 425,524)

TOTAL 1,177,572 89,652 ( 1,077,920)

This ICR represents a reduction in expected burden of over three quarters of that reported in the May 1997 ICR, even though the number of affected sources increases by almost 50 percent. Table E 1 displays the expected annual burden and the expected change in annual burden for sources and the Federal government for implementation of the title V Federal Operating Permits Program between August 2000 and August 2003. In the May 1997 ICR, the Agency estimated the annualized burden to sources at 678 thousand hours. No sources in Indian Country or OCS areas were included. The previous ICR included 2,059 sources while this update expects 3,179 sources will be effected, including 95 in Indian Country and 3,084 sources in State or local jurisdictions. The reduction in E 2 burden happens because most of the sources in this ICR already have permits  the most costly of the activities they must perform. The Agency estimated the Federal burden for administrating a part 71 permit program at 500 thousand hours in the last ICR, while this update predicts less than half of that, 223 thousand hours. Because the cost per hour for the 1997 ICR and this update are fundamentally the same, the reduction in burden translates directly into a similar reduction in costs. CONCLUSION:

This ICR represents a DECREASE IN BURDEN, relative to the Federal Operating Permits Program's prior ICR.

Because this ICR represents a decrease in burden, the Agency determined there is NO SIGNIFICANT IMPACT ON A SUBSTANTIAL NUMBER OF SMALL ENTITIES. Table of Contents Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E 1 1. Identification of the Information Collection . . . . . . . . . . . . . 1 2. Need and Use of the Collection . . . . . . . . . . . . . . . . . . . . . . . . 3 3. Non Duplication, Consultation, and Other Collection Criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 4. The Respondents and the Information Requested . . . . . . . . 7 5. The Information Collected  Collection Methodology, and Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 6. Estimating the Burden and Cost of the Collection . . . . . . . 11 Attachment 1 The Statutory Requirements for Respondent Information . 28 Attachment 2 May 1, 2000 Federal Register Notice . . . . . . . . . . . . . . . . . . 41 Information Collection Request For Part 71 Operating Permit Regulations Page 1 3 June 2003 This analysis is titled: " Information Collection Request For Part 71 Federal Operating Permit Regulations". It fulfills the Agency's require ments under the Paperwork Reduction Act ( PRA) to determine, report, and periodically update the regulatory burden associated with the Federal Operating Permits Program,

codified in section 40 of the Code of Federal Regulations ( 40 CFR) part 71. It has been assigned EPA tracking number ICR #

1713.04 and OMB tracking number 2060

0336.

The part 71 program is a Federal operating permits program implemented for sources located in Indian Country, Outer Continental Shelf sources, and in areas without acceptable part 70 programs. Title V of the Clean Air Act imposes on States the duty to develop, administer and enforce operating permit programs which comply with title V and requires EPA to stand ready to issue Federal operating permits when States fail to perform this duty. Section 502( b) of the Act requires EPA to promulgate regulations setting forth provisions under which States will develop operating permit programs and submit them to EPA for approval. Pursuant to this section, EPA promulgated 40 CFR part 70 on July 21, 1992 ( 57 FR 32250) which specifies the minimum elements of State operating permit programs.

Pursuant to regulations promulgated by EPA on February 19, 1999 ( 64 FR 8247) EPA has authority to establish part 71 programs within Indian Country and EPA began administering the program in Indian country on March 22, 1999. Since many Indian tribes lack the resources and capacity to develop operating permit programs, EPA will administer and enforce part 71 programs in the areas that comprise Indian Country in order to protect the air quality of areas under tribal jurisdiction. 1 Identification of the Information Collection 1.1 Title EPA TRACKING NUMBER: 1713.04 OMB TRACKING NUMBER: 2060 0336 1.2 Description 1.2.1 Permanent Programs for Tribes and OCS Information Collection Request For Part 71 Operating Permit Regulations Page 2 3 June 2003 The EPA intends to protect tribal air quality through the development of implementation plans, permits programs and direct assistance to tribes in developing comprehensive and effective air quality management programs.

The EPA will consult with tribes to identify their particular needs for air program development assistance and will provide ongoing assistance as necessary. There are approximately 95 sources in Indian country that require part 71 permits.

EPA is the permitting authority for sources beyond 25 miles ( 40 km) of the States' seaward boundaries ( Outer Continental Shelf or OCS), and the provisions of part 71 apply to the permitting of those sources, as well.

There are only two OCS sources that fall under the jurisdiction of the Federal program.

Section 502( d)( 3) of the Act requires EPA to promulgate, administer, and enforce a program for a State if an operating permits program for the State had not been approved by November 15, 1995. The EPA suspended that requirement if a State program was granted interim approval. If the interim approval of a State program expires, and if corrective program provisions have not have been adopted and submitted to EPA in time for full approval prior to the expiration of the State's interim approval, EPA must establish a part 71 program for that State, effective immediately upon that expiration.

Pursuant to regulations promulgated by EPA on July 1, 1996 ( 61 FR 34202) EPA has authority to establish part 71 programs if States fail to perform their permitting duties.

For the 3 year period covered by this ICR, 38 Permitting Authorities ( PAs)

identified by the Agency that were granted interim approval of their title V programs may not been granted final approval by EPA by November 30,

2001, when the State and local portion of this regulation takes effect.

Consequently, the Agency will have the responsibility for management of the operating permit program in these PAs until such time as the deficiencies in these areas have been corrected. These 38 PAs for the basis for this ICR's State and local program component. 1.2.2 Temporary Programs in State and Local Areas Information Collection Request For Part 71 Operating Permit Regulations Page 3 3 June 2003 To ensure the continued improvement of air quality in the United States,

State and local permitting authorities ( PAs) must develop air pollution management programs and submit them to EPA for approval ( section 502( d)). Each air pollution source subject to a State's program must then submit an operating permit application to the PA, describing those pollution control requirements to which it is subject. Once approved, the source must renew its permit every five years. Permit applications and proposed permits will be provided to, and are subject to review by, EPA ( section 505( a)). The permit and all information submitted by a source shall be available for public review except for confidential information which will be protected from disclosure ( section 503( e)) and the public shall be given public notice of, and an opportunity for comment on, permit actions ( section 502( b)( 6)). Sources will semi annually submit compliance monitoring reports to the permitting authorities ( section 504( a)). The EPA has the responsibility to oversee implementation of the program ( section 502( d)( 3)). A copy of sections 502 through 504 of title V of the Act are in Attachment 1.

For EPA to carry out its required oversight function of reviewing proposed permits and permit revisions and assuring adequate implementation of the program, it must have available to it information on permit applications and issuance, permit revisions and renewals, and source data reports. The burden estimates included in this ICR provides emissions, source, and control information for the title V program.

The information included in this ICR is based upon the best data available to the Agency at this time. However, inconsistencies in PA reporting techniques, incomplete data sets, and sampling limitations imposed upon the Agency by the Paperwork Reduction Act necessitated a certain amount of extrapolation and " best guess" estimations by PA and Agency experts.

Consequently, the reader should not consider the conclusions to be an exact representation of the level of burden or cost that will occur during the three years of this ICR. Instead, this ICR should be considered a 2 Need and Use of the Collection 2.1 Need / Authority for the Collection 2.2 Practical Utility / Users of the Data 2.3 Caveats and Considerations Information Collection Request For Part 71 Operating Permit Regulations Page 4 3 June 2003 directionally correct assessment of the impact the Federal Operating Permits Program will have over the next three years.

Throughout this ICR, the reader will observe estimated values that show accuracy to the single hour or dollar. However, reporting values at the single unit level can be misleading. In most situations, the proper way to present estimated data would be to determine an appropriate level of precision and truncate values accordingly, usually in terms of thousands or millions of units. For instance, a spreadsheet generated estimation of $ 5,456,295 could be presented in the text as $ 5.5 ( millions) or $ 5,456 ( thousands). One problem with such an approach is the loss of data richness when the report contains a mixture of very large and very small numbers. Such was the case with this ICR, where source values are consistently in the millions and Federal values in the tens of thousands.

Consequently, to avoid the loss of information through rounding, this ICR reports all values at the single unit level and reminds the reader that there is no implied precision inherent in this style of reporting. Information Collection Request For Part 71 Operating Permit Regulations Page 5 3 June 2003 The need for the data required by the part 70 and part 71 operating permits programs has been well documented in prior ICRs for both programs.

While much of the information requested under this ICR existed prior to the creation of the operating permits program, an operating permit is a compilation of existing requirements; the purpose being to bring all requirements applicable to a source into one document. The intent of this compilation is to ( 1) resolve any questions of applicability at the time of permit issuance, ( 2) provide certainty to sources as to their obligations, and ( 3) provide the public access to a source's obligations and compliance status. The Agency cannot ignore its requirement for such previously existing information under this ICR since consolidation of the information into the operating permit and providing public access is the whole purpose of the statute. To the extent that similar information was previously collected ( e. g., State permits under State plans), the program may replace those activities and avoid duplication of efforts.

For any existing rule, § 3507( g) of the PRA limits how long a Director may take to approve a collection of information to 3 years. On May 31, 1997,

OMB approved the ICR for part 71 ( OMB number 2060 0336, EPA tracking number 1713.03). That ICR was due to expire on May 31, 2000,

and was granted an Emergency Extension until October 31, 2000. This ICR is a renewal of the May 31, 1997 ICR.

Except for information collection in notices of proposed rules or those exempted under the emergency processing provisions of 44 U. S. C. § 3507( j), the PRA requires EPA to solicit comment on each proposed information collection, including the renewal or modification of any existing ICR. On May 1, 2000, ( 65 FR 25322) EPA published a notice soliciting comment on an analysis of burden for the part 71 program for the 3 year period of this ICR ( i. e., May 31, 2000 to May 31, 2003). No comments were received. A copy of the May 2000 notice is included in this ICR as Attachment 2. 3 Non Duplication, Consultation, and Other Collection Criteria 3.1 Non Duplication 3.2 Public Notice Requirements Information Collection Request For Part 71 Operating Permit Regulations Page 6 3 June 2003 In preparing this ICR, EPA worked closely with experts from EPA regional offices and within PA's offices to obtain estimates of the burden of the various activities associated with the part 70 program.

In general, collection of the information included in this ICR occurs once per activity ( e. g., permit application or permit issuance). Periodic activities include a semi annual compliance monitoring data report and an annual compliance certification from each source required by section 503( b)( 1)

and ( 2), respectively, of the Act. EPA has no leeway to require less frequent reporting.

The CAA requires retention of all monitoring data and support information and all permit applications, proposed permits, and final permit records for a period of 5 years. These records are necessary to fulfill the intent of title V to assure compliance with applicable requirements. Questions regarding the obligations of a source and its status of compliance can be resolved through such records.

All information related to the permitting of sources under this program and related to compliance monitoring are required by section 503( e) of the Act to be subject to public review at all times. Section 70.4( b)( 3)( viii) requires the permitting authority to make available to the public any permitting information except that entitled to protection from disclosure under section 114( c) of the Act. Protected information may be required to be submitted directly to EPA. Such information will be stored in EPA's Confidential Business Information office. 3.3 Consultations 3.4 Effects of Less Frequent Collection 3.5 General Guidelines 3.6 Confidentiality 1 Outer continental shelf sources are also subject to title V permitting under part 71, but there are no OCS sources at this time that need an operating permit. See section 1.2.1.

Information Collection Request For Part 71 Operating Permit Regulations Page 7 3 June 2003 Respondents to this information collection come from sources of pollution in Indian Country and sources on State or local PAs for which a fully approved title V permitting program is not in place and interim approval has run out. 1 For the purposes of this ICR, the Agency identified 30 source permits in Indian country and 65 additional sources in Indian country that will need permits within the time frame of this ICR. There are 38 state and local PA areas that meet the last requirement and will be included in this ICR. Information provided to the EPA by permitting authorities indicate those 38 PAs will have permitted 1,716 sources as of November 30, 2001.

All activities associated with the operating permits program are considered part 71 information collection activities and are reflected in this ICR.

Following are lists of the data items submitted by sources and permitting authorities for the latest ICR for part 70. These activities represent the Agency's best representation of the burdens experienced by sources and PAs for part 70 and 71 requirements.

Under Operating Permits rules, the following data items must be submitted by PAs to the EPA:

1. Application for permits, permit revisions, and permit renewals 2. Draft / proposed permits, permit revisions, or permit renewals 3. Final permit 4. Annual report of enforcement activities 5. Semi annual report on compliance monitoring For the permanent program for Indian country and OCS sources, these submittals are not necessary because the Agency assumes the role of PA under part 71. Similarly, the Agency does not need a formal submittal for State and local PA programs if the EPA manages this program itself. 4 The Respondents and the Information Requested 4.1 Respondents 4.2 Information Requested 4.2.1 Required Data Items Information Collection Request For Part 71 Operating Permit Regulations Page 8 3 June 2003 However, if the Agency delegates management of a State or local PA program back to the State or local governmental agency, these data would need to be provided to the EPA to fulfill its oversight function.

Under Operating Permit rules, the following data items must be submitted by sources to PAs:

1. Applications for permits, permit revisions, and permit renewals 2. Semi annual periodic monitoring reports 3. Annual compliance certification reports Because the Agency assumes the role of the PA under part 71, sources will submit these data directly to the EPA for action. Attachment 1 includes these statutory requirements for reference purposes. Information Collection Request For Part 71 Operating Permit Regulations Page 9 3 June 2003 For the permanent part of the Federal Operating Permits program, EPA will receive data from sources in much the same manner as that established for sources reporting to PAs in the part 70 program. For State and local PA programs delegated back to the PA under part 71, EPA will receive copies of each permit application ( including any application for permit modification), each proposed permit, and each final part 71 permit in hard copy or electronically, depending on delegate agency capability. Each EPA Regional Office will work with their delegate agencies ( if any) to determine the most efficient system to exchange information. In the case of a nondelegated State and local part 71 program, the EPA will retain copies of each permit application ( including any application for permit modification),

each draft permit, and each final part 71 permit.

Title V provides few ways to mitigate the effects of operating permit regulations on small entities. Under section 502( a) of the Act, the Agency has exempted or deferred applicability of title V to most non major source categories for which compliance with title V will be impracticable,

infeasible, or unnecessarily burdensome. The Agency has not analyzed how many of these non major sources will be small businesses, but believes that a large percentage may fall under that definition.

In accordance with the analytical requirements established under the Regulatory Flexibility Act ( RFA) and the Small Business Regulatory Enforcement Fairness Act ( SBREFA), the Agency has determined that,

because this ICR represents no substantial change from its predecessor,

there are no adverse effects to be identified vis a vis small entities and small businesses.

Items identified in section 4.2.1 are listed below with their schedule for submission.

Permitting Authorities ( submitted to EPA for delegated programs): 5 The Information Collected  Collection Methodology, and Information Management 5.1 Collection Methodology and Management 5.2 Small Entity Flexibility 5.3 Collection Schedule Information Collection Request For Part 71 Operating Permit Regulations Page 10 3 June 2003 $ Applications for permits, permit revision, and permit renewal should be submitted to EPA with the proposed permit or permit revision.

$ Draft/ proposed permits, permit revisions, or permit renewals should be submitted when the State wants to commence the EPA review period of the proposed permit or permit revision.

$ Final permits should be submitted to EPA soon after it is issued, but there is no deadline in part 71 for this submission.

$ Annual reports of enforcement activities are submitted to EPA annually, but part 71 does not specify a date.

Sources ( submitted to permitting authority):

$ New permit applications are due within 1 year after a source becomes subject to the program.

$ Permit revision applications are submitted by a source when it wishes to make a change to its permit. There is no schedule for these submissions in that they are triggered by modifications by the source.

$ Permit renewal applications are due at least 6 months prior to expiration of the permit.

$ Semi annual periodic monitoring reports are due to be submitted to the permitting authority twice a year on dates specified by the permitting authority.

$ Annual compliance certification reports are due annually on a date specified by the permitting authority. Information Collection Request For Part 71 Operating Permit Regulations Page 11 3 June 2003 There are 112 part 70 permitting authorities acting within the United States. Forty nine states operate as permitting authorities, with California employing 34 local air quality management districts in lieu of a statewide permitting authority. Puerto Rico, the Virgin Islands, and Washington D. C.

also have operating permits programs, and there are 26 county or regional permitting authorities within states that operate in a manner similar to that of the California districts. The Agency has identified 38 of these PAs that are not expected to have full program approval as of the expiration date of their interim approvals. They form the basis for the part 70 State and local portion of this ICR. Since 33 of the 38 PAs are small, this ICR aggregated them into one " agency" for analytical purposes. One additional California PA, South Coast, is sufficiently large to be considered its own agency, and the remaining four PAs are states.

TABLE 1 IMPLEMENTATION SCHEDULE FOR PART 71 SOURCES FROM INDIAN COUNTRY FROM STATES June 1, 2000 * 30 0 December 1, 2000 0 0 June 1, 2001 65 0 December 1, 2001 0 1,716 June 1, 2002 0 456 December 1, 2002 0 912 June 1, 2003 0 0 Total 95 3,084 * 30 sources in Indian country will have been granted permit approval before the beginning of this ICR time frame, They will begin reporting requirements with the December 1, 2000 due date.

About fifty more local and state PAs have interim approvals at the time of this analysis, but the Agency believes that their programs will be granted full approvals prior to the expiration of their interim approvals. Table 1 lists all of the affected sources from permanent and part 70 State and regional 6 Estimating the Burden and Cost of the Collection 6.1 Estimating The Number of Respondents There are 3,179 affected sources in this ICR:

1,716 permitted part 70 State sources 1,362 additional sources without part 70 permits, of which 456 will be issued during the period of this ICR 6 new part 70 State sources which will require applications during the period of this ICR 95 sources in Indian country 2 U. S. EPA, 2000, Information Collection Request For Part 70 Operating Permit Regulations, Appendix 4.

3 May, 1995, United States Environmental Protection Agency, Part 71 Information Collection Request, p 19.

Information Collection Request For Part 71 Operating Permit Regulations Page 12 3 June 2003 PAs that will be included in this analysis and the date they begin being subject to part 71 Federal Operating Permits requirements.

During the three years of this ICR, the Agency will manage 95 sources in Indian country. During this same period, the Agency will also manage more than three thousand sources in states and regional areas where permitting authorities will not have a fully approved part 70 program. 1,716 of these sources will have already been permitted under the PA's interim approval authority by November 30, 2001; and an additional 1,362 sources will not have not been permitted. In accordance with the Agency's expectations for new source permits delineated in the latest ICR for part 70, EPA expects one new source per year will arise in each PA. 2 Six new sources will require permits during this ICR because of that assumption.

Table 2 displays the expected source burden for all of the activities required under part 70 and 71. Burden means the total time, effort, and financial resources expended by persons to generate, maintain, retain,

disclose, or provide information to or for a Federal agency. This includes the time needed to review instructions; 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.

In the initial ICR for part 71, the Agency assumed sources are indifferent ( from an effort perspective) between reporting to the Federal government and reporting to a State permitting authority. 3 Consequently, Table 2 is the same for both part 70 estimates and this ICR. 6.2 Estimating Burden Information Collection Request For Part 71 Operating Permit Regulations Page 13 3 June 2003 TABLE 2 PART 70 AND 71 SOURCE BURDEN BY ACTIVITY ACTIVITY BURDEN PER SOURCE OR PERMIT Prepare Application 300 hrs Draft Permit Interaction 40 hrs Gap filling Monitoring Development 40 hrs Public Hearing Participation 10 hrs Operate Gap filling Periodic Monitoring 200 hrs Prepare Monitoring Reports 80 hrs Permit Revisions Significant Permit Modifications ( 10% of Permits) Minor Permit Modifications ( 50% of Permits) Administrative Amendments ( 50 % of Permits) 80 hrs 40 hrs 8 hrs Permit Renewal 200 hrs Other Activities 20 hrs The following tables and descriptions include PA burden estimates for specific activities required by the Agency. In all cases, the PA activities listed for the Agency match those of PAs under the part 70 program, and EPA Source and Federal Level activities match those for the Agency under part 70.

PERMITTING AUTHORITY ACTIVITIES 1. Program administration: Responding to inquiries about the program,

developing internal and external program guidance, planning, attending program training, permit fee collection, providing source training,

attending meetings and conferences, providing public education, and other program related activities 2. Permit review: including discussions with a source concerning the permit application 3. Draft permit preparation: including contact with the source 4. Comment period notification: Providing notice to the public, EPA ( for delegated programs), and affected States of the comment period on a draft permit Information Collection Request For Part 71 Operating Permit Regulations Page 14 3 June 2003 5. Public hearing administration: provide notice to the public and affected states of the comment period on a draft permit 6. Interaction with EPA ( for delegated programs): on a proposed permit, including negotiations, re drafting, and formal EPA objections ( including those attributable to public petitions)

7. Response to public comments: Analyzing public comments and revising the permit accordingly 8. Permit issuance: including web activities and source notification 9. General permits administration: ( This ICR does not include provisions for general permitting. The burden for issuing general permits is included with other permit issuance burden categoreis.)

10. Permit revision: review permit revision applications, drafting any changes, public notice, issuance 11. Permit renewal: reviewing application, drafting any changes, public notice, issuance 12. Monitoring and compliance certification: Reviewing semiannual monitoring reports and annual compliance certification 13. Annual reporting: Preparing and submitting to EPA ( for delegated programs) annually a report of the State's enforcement activities SOURCE SPECIFIC PERMITTING AUTHORITY ACTIVITIES 1. Permit application preparation: including internal meetings,

permitting authority discussions, management and legal department involvement, responsible official certification, contractor services 2. Draft permit development: Interaction with the permitting authority on draft permit development 3. Gap filling development: Development of periodic monitoring gapfilling 4. Public hearing participation: provide notice to the public and affected states of the comment period on a draft permit 5. Operate gap filling periodic monitoring: ( annual burden to operate monitors, keep records, etc.)

6. Monitoring reports: Preparing semi annual monitoring data reports,

including data analysis, responsible official certification, and report Under a part 71 Operating Permits Program, the EPA must perform all of the activities that would normally be performed by the state or local permitting authority unless delegated. Information Collection Request For Part 71 Operating Permit Regulations Page 15 3 June 2003 submission ( annual burden for both reports). Include preparing and submitting annual compliance certification 7. Permit revisions: reviewing permit revision applications, drafting any changes, public notice, issuance 8. Permit renewal: reviewing application, drafting any changes, public notice, issuance 9. Other activities associated with permit renewal: including discussions with permitting authority and public hearing participation.

EPA ACTIVITIES FOR DELEGATED PROGRAMS 1. Review proposed permits and permit revisions: determine if they provide for compliance with all applicable requirements 2. Review periodic monitoring provisions: determine adequacy to demonstrate compliance with applicable requirements 3. Consult with the permitting authority: address any problems detected in the proposed permit or permit revision 4. Review annual reports of enforcement activities Information Collection Request For Part 71 Operating Permit Regulations Page 16 3 June 2003 TABLE 3 PERMITTING AUTHORITY BURDEN BY ACTIVITY ACTIVITY PART 70 BURDEN PER PERMIT OR PROGRAM PART 71 BURDEN PER PERMIT OR PROGRAM  DELEGATED TO THE PA PART 71 BURDEN PER PERMIT OR PROGRAM  NO DELEGATION PART 71 BURDEN PER PERMIT OR PROGRAM  PREPARED BY A CONTRACTOR Program Administration 3,500 hrs / PA 3,850 hrs / PA 4,200 hrs / PA 5,250 hrs / PA Permit Application Review 100 hrs / permit 110 hrs / permit 120 hrs / permit 150 hrs / permit Draft Permits Preparation 150 hrs / permit 165 hrs / permit 180 hrs / permit 225 hrs / permit Comment Period Notification 10 hrs / permit 11 hrs / permit 12 hrs / permit 15 hrs / permit Hold Public Hearings 100 hrs / hearing 110 hrs / hearing 120 hrs / hearing 150 hrs / hearing Interaction with EPA 20 hrs / permit 22 hrs / permit 24 hrs / permit 30 hrs / permit Analyze Public Comments 40 hrs / permit 44 hrs / permit 48 hrs / permit 60 hrs / permit Permits Issuance 8 hrs / permit 9 hrs / permit 10 hrs / permit 12 hrs / permit General Permits 80 hrs / PA 88 hrs / PA 96 hrs / PA 120 hrs / PA Permit Revision Significant Modification Minor Permit Modification Administrative Amendment 60 hrs / permit 20 hrs / permit 5 hrs / permit 66 hrs / permit 22 hrs / permit 6 hrs / permit 72 hrs / permit 24 hrs / permit 6 hrs / permit 90 hrs / permit 30 hrs / permit 8 hrs / permit Permits Renewal 60 hrs / permit 66 hrs / permit 72 hrs / permit 90 hrs / permit Renew General Permits 10 hrs / permit 11 hrs / permit 12 hrs / permit 15 hrs / permit Review Reports: Monitoring Compliance Certification Enforcement Activity 5 hrs / permit 5 hrs / permit 40 hrs / permit 6 hrs / permit 6 hrs / permit 44 hrs / permit 6 hrs / permit 6 hrs / permit 48 hrs / permit 8 hrs / permit 8 hrs / permit 60 hrs / permit Table 3 displays the expected PA burden for all of the specific tasks necessary for the PA to perform its management function. Column 2 of Table 3 displays the PA burden under an approved part 70 program.

Delegation of a PA's operating permit program back to the PA forms the basis for this analysis. EPA believes delegation may in some cases be the most efficient way to manage state derived part 71 programs. However,

even if the Federal government delegates its authority back to the original permitting authority, the additional layer of management required for Federal oversight would necessitate an increase in part 71 burden.

Consequently, column 3 of Table 3 shows a 10% " efficiency factor"

increase in burden for each activity, relative to part 70. Information Collection Request For Part 71 Operating Permit Regulations Page 17 3 June 2003 The Agency believes that it will take longer for the EPA to do the same task under part 71 instead of the PA because the permitting authority generally has a comparative advantage over the part 71 program manager.

The Agency must first gather sufficient human capital ( experience,

background, etc.) to perform its duties, thereby increasing the program's burden over that of a PA managed program. Therefore, column 4 of Table 3 shows a 20% " efficiency factor" increase in burden for each activity,

relative to its part 70 level. Preparation by a contractor would further increase part 71 burden. Not only would there have to be Federal oversight of the delegated authority, such delegation adds burdens for contract administration ( to the Federal government and the contractor,)

development of human capital, and overhead. Column 5 of Table 3 shows a 50% " efficiency factor" increase in burden for each activity to account for the added inefficiency.

TABLE 4 EPA PART 70 AND 71 ACTIVITIES ACTIVITY BURDEN PER PERMIT OR PROGRAM Review Proposed Permits * New Permits ( 25% of all title V sources) Significant Permit Modifications Minor Permit Modifications 20 hrs / permit 8 hrs / revision 1 hrs / revision Consultation New Permits ( 25% of all title V sources) Significant Permit Modifications( 25% of all title V sources) Minor Permit Modifications ( 25% of all title V sources) 8 hrs / permit 8 hrs / permit 1 hr / permit Review the Annual Enforcement Activity Reports 10 hrs. per report * Includes the burden for review of periodic monitoring.

Based upon its experience with the operating permits program over the past eight years, the Agency revised its estimations of the Federal burden from the categories discussed above. These revisions appeared in the latest ICR report for the part 70 program and are included in Table 4.

6.3 Estimating Wages 4 Due to the confidential nature of the data employed, this ICR does not offer any tables or appendices detailing the derivation of this contractor burden rate.

Information Collection Request For Part 71 Operating Permit Regulations Page 18 3 June 2003 This ICR employs wage rates consistent with its part 70 counterpart,

adjusted through the latest Bureau of the Census Employment Cost Index ( ECI) for white collar occupations. The Agency extrapolated from 1996 to 1999 by taking the average increase in ECI for 1994, 95, and 96 and applying that average to each of the three years between 1997 and 1999,

resulting in an approximation of the true ECI of 108.6 for 1999. Table 5 below displays the calculation of the true industry wage rate ( plus overhead) for source in house activities.

TABLE 5 DETERMINATION OF SOURCE WAGE RATES Annual Salary, Technical Support, ( FY 96, adjusted to 1999 ) * $ 36,537.38 Annual Salary, Administrative Staff, ( FY 96, adjusted )* $ 34,786.75 Factor ( 1/ 11) ** 0.09 $ 3,162.12 Annual Cost of Admin. Support Staff, ( FY 96 , adjusted to 1999 )* Factor ( 1/ 8) ** $ 22,080.55 0.13 $ 2,760.07 Annual Applicable Salary of Permit Staff $ 42,459.57 Benefits ( at 16%) $ 6,793.53 Sick Leave / Vacation ( at 10%) $ 4,245.96 General Overhead $ 13,727.18 Total Cost Per FTE $ 67,226.24 Total Hourly Cost ( Total Per FTE divided by 2,080 hours per year) $ 32.32 * U. S. Department of Commerce, Economics and Statistics Administration, Bureau of the Census; Statistical Abstract of the United States, 1997, Table 672. http:// www. bea. doc. gov/ bea/ dn/ aadata. exe, December 7, 1999 ** Based on an administrator managing a staff of ten technicians and one support staff person This analysis assumes any contracted labor employed by a source for operating permit management and reporting would require the same skills and compensation rates used by the EPA's consultants. To estimate source consulting costs, the Agency averaged the fully loaded cost of three environmental contractors at the PL 2 ( secretarial support), PL 3 ( technical), and PL 4 ( administration) levels and applied these averages to the methodology employed in Table 5 for establishing a Federal and PA full time employee wage rate. Through this methodology, the Agency derived a fully loaded hourly wage rate for Industry hired consultants of $ 268 4. Therefore, source cost estimates for permit preparation use an Information Collection Request For Part 71 Operating Permit Regulations Page 19 3 June 2003 hourly rate of $ 111 ( 1/ 3 of $ 268 plus 2/ 3 of $ 32). All other source tasks are estimated at $ 32 per hour.

During the development of the previous ICR for the part 71 Federal Operating Permit Regulations, the Agency developed a process to determine the appropriate wage rates to apply to Federal burden categories. For this ICR, the appropriate cost of Federal and permitting authority burden is $ 37 per hour. Table 6 displays the calculation of this rate.

TABLE 6 DETERMINATION OF FEDERAL WAGE RATES Annual Salary of Permit Staff, GS 11 Step 3 ( FY 99 Schedule)* $ 40,260.00 Annual Cost of Supervisory Staff, GS 13 Step 3 ( FY 99 Schedule)* $ 57,379.00 Factor ( 1/ 11) ** 0.09 $ 5,164.11 Annual Cost of Support Staff, GS 6 Step 6 ( FY 99 Schedule)* Factor ( 1/ 8) ** $ 26,773.00 0.13 $ 3,346.63 Annual Applicable Salary of Permit Staff $ 48,770.74 Benefits ( at 16%) $ 7,803.32 Sick Leave / Vacation ( at 10%) $ 4,877.07 General Overhead $ 15,767.58 Total Cost Per FTE $ 77,218.70 Total Hourly Cost ( Total Per FTE divided by 2,080 hours per year) $ 37.12 * http:// www. opm. gov/ oca/ 99tables/ GSannual/ gsannpdf/ 99GS. PDF, December 7, 1999 ** Based on an administrator managing a staff of ten technicians and one support staff person Information Collection Request For Part 71 Operating Permit Regulations Page 20 3 June 2003 TABLE 7 THE BURDEN AND COST OF SOURCE ACTIVITIES FOR THE PERMANENT FEDERAL PROGRAM ACTIVITY AFFECTED PERMITS TOTAL THREE YEAR BURDEN ( HOURS) AVERAGE BURDEN ( HOURS) TOTAL THREE YEAR COST ($ 1999) AVERAGE COST ($ 1999)

Permit Application 65 19,500 6,500 $ 2,164,500 $ 721,500 Gap Filling Monitoring Development 48 1,920 640 $ 61,440 $ 20,467 Public Hearing Participation 2 20 7 $ 640 $ 213 Operate Gap Filling Monitoring year 1 10 year 2 22 year 3 0 year 1 2,000 year 2 4,400 year 3 0 6,400 667 1,467 0 2,133 $ 64,000 $ 140,800 $ 0 $ 204,800 $ 21,333 $ 46,933 $ 0 $ 68,267 Prepare Monitoring Reports year 1 0 year 2 30 year 3 95 year 1 0 year 2 2,400 year 3 7,600 10,000 0 800 2,533 3,333 $ 0 $ 76,800 $ 243,200 $ 320,000 $ 0 25,600 $ 82,733 $ 10,667 Permit Revisions Significant Permit Mods Minor Permit Mods Adminin Amendments year 1 3 year 2 10 year 3 10 year 1 15 year 2 48 year 3 48 year 1 15 year 2 48 year 3 48 year 1 240 year 2 800 year 3 800 1,840 year 1 600 year 2 1,920 year 3 1,920 4,440 year 1 120 year 2 384 year 3 384 888 7,168 80 267 267 613 200 640 640 1,480 40 128 131 296 2,389 $ 7,680 $ 25,600 $ 25,600 $ 58,880 $ 19,200 $ 61,440 $ 61,440 $ 142,080 $ 3,840 $ 12,288 $ 12,288 $ 28,416 $ 229,376 $ 2,560 $ 8,533 $ 8,533 $ 19,627 $ 6,400 $ 20,480 $ 20,480 $ 47,360 $ 1,280 $ 4,296 $ 4,296 $ 9,472 $ 76,459 Other Activities 48 960 920 $ 30,720 $ 10,240 TOTALS 45,968 15,323 $ 2,723,476 $ 907,825 * 95 total permits ** 1/ 3 contractor support, 2/ 3 in house Table 7 lists the burden categories, expected number of occurrences for each, and the associated burden and costs for sources for the permanent Federal program. The quantities in column two are from direct assessments of the 95 Indian country permits. Each activity in Table 7 is based on the burden estimates from Table 2. The burden for sources in states or local 6.4 Estimating Costs for the Permanent Federal Program 6.4.1 Estimating Source Costs Information Collection Request For Part 71 Operating Permit Regulations Page 21 3 June 2003 PAs that will require part 71 intervention will not have an additional burden associated with their part 71 applications, so this ICR does not report their permitting burden.

TABLE 8 THE BURDEN AND COST OF FEDERAL ACTIVITIES FOR THE PERMANENT PROGRAM Total Number of Entities Activity Hours Dec 2000 Jun 2001 Dec 2001 Jun 2002 Dec 2002 Jun 2003 Cost *

Program Administration 3,500 1 1 1 1 1 1 $ 777,000 Permit Application Review 100 0 65 0 0 0 0 $ 240,500 Draft Permit Preparation 150 0 65 0 0 0 0 $ 360,750 Comment Period Notification 10 0 65 0 0 0 0 $ 24,050 Public Hearings 100 0 65 0 0 0 0 $ 240,500 Analyze Public Comments 40 0 65 0 0 0 0 $ 96,200 Permit Issuance 8 0 65 0 0 0 0 $ 19,240 Permit Revisions Significant Modifications 60 2 5 5 5 5 6 $ 62,160 Minor Permit Modification 20 8 24 24 24 24 24 $ 94,720 Administrative Amendment 5 8 24 24 24 24 24 $ 23,680 Review Reports Monitoring 5 30 30 95 95 95 95 $ 81,400 Compliance Certification 5 30 30 95 95 95 95 $ 81,400 Enforcement Activity 40 0 30 0 95 0 95 $ 325,600 TOTAL COSTS $ 2,427,200 * The wage rate applied was $ 37 per hour, see Section 6.3.1 Estimating Source Costs for details.

Table 8 lists the burden categories for the permanent portion of the Federal program ( i. e., where the Federal government acts as the permitting authority,) the expected number of permits involved, and the expected cost for each category, based on the burden estimations from Table 3. Table 9 lists the burden categories for the portion of the Federal Operating Permits 6.4.2 Estimating Federal Costs Information Collection Request For Part 71 Operating Permit Regulations Page 22 3 June 2003 program for programs in areas where a State or local PA does not have a fully approved title V program.

TABLE 9 THE ADDITIONAL BURDEN AND COST OF FEDERAL ACTIVITIES FOR STATE AND LOCAL PERMITTING AUTHORITY PROGRAMS Total Number of Entities Activity Hours Dec 2000 Jun 2001 Dec 2001 Jun 2002 Dec 2002 Jun 2003 Cost *

Program Administration 350 0 0 6 6 6 6 $ 310,800 Permit Application Review 10 0 0 0 0 456 912 $ 506,160 Draft Permit Preparation 15 0 0 0 0 456 912 $ 759,240 Comment Period Notification 1 0 0 0 0 456 912 $ 50,616 Public Hearings 10 0 0 0 0 456 912 $ 506,160 Analyze Public Comments 4 0 0 0 0 456 912 $ 202,464 Permit Issuance 1 0 0 0 0 456 912 $ 50,616 Permit Revisions Significant Modifications 6 0 0 86 109 154 154 $ 111,666 Minor Permit Modification 2 0 0 429 541 768 768 $ 185,444 Administrative Amendment 1 0 0 429 541 768 768 $ 92,722 Permit Renewal 6 0 0 0 0 0 166 $ 36,852 Review Reports Monitoring 1 0 0 1,716 1,716 1,716 2,162 $ 270,470 Compliance Certification 1 0 0 1,716 1,716 1,716 2,162 $ 270,470 Enforcement Activity 4 0 0 1,716 0 1,716 0 $ 507,936 TOTAL COSTS $ 3,861,616 * The wage rate applied was $ 37 per hour, see Section 6.3.1 Estimating Source Costs for details.

As in Table 8, the data in Table 9 are based on the burden estimations from Table 3. As discussed in section 6.2, above, the Agency believes delegation of the part 71 program back to the permitting authority may be the most efficient means of managing the State and local PA portion of the Information Collection Request For Part 71 Operating Permit Regulations Page 23 3 June 2003 part 71 program. Therefore, the burden estimates in Table 9 are additional burden hours, above and beyond those necessary for a part 70 program.

TABLE 10 EPA ACTIVITIES FOR THE PART 71 OPERATING PERMITS PROGRAM ACTIVITY AFFECTED PERMITS OR PROGRAMS TOTAL BURDEN ( HOURS) TOTAL COST * ($ 1999)

Review permits and revisions New Permits Significant permit revisions ( 25% of permits)

Minor Permit Revisions ( 25% of permits) 1,463 permits **

year 1 0 year 2 195 year 3 308 year 1 0 year 2 970 year 3 1,536 29,260 0 1,560 2,464 4,024 0 970 1,536 2,506 $ 1,082,620 $ 0 $ 57,720 $ 91,168 $ 14,8888 $ 0 $ 35,890 $ 56,832 $ 92,722 Consult with PA New Permits Significant Permit Revisions ( 6.25% of permits)

Minor Permit Revisions ( 6.25% of permits) 1,368 permits ***

year 1 0 year 2 49 year 3 77 year 1 0 year 2 243 year 3 384 10,944 0 392 616 1,008 0 243 384 627 $ 404,928 $ 0 $ 14,504 $ 22,792 $ 37,296 $ 0 $ 8,991 $ 14,208 $ 23,199 Review the annual report 172 / yr 4,650 $ 172,050 TOTALS 53,019 $ 1,827,703 * The wage rate applied was $ 37 per hour, see Section 6.3.1 Estimating Source Costs for details. ** 1,463 permits include 95 in Indian County and 1,368 in States or local PA jurisdictions. *** 1,368 permits only from States or local PA jurisdictions.

In addition to the burden EPA must assume for State and local areas without an approved title V program, the Agency must also perform oversight tasks that, on the surface, appear redundant, relative to the tasks included in Table 9. However, Table 9 assumes delegation of the program back to the Permitting Authority and therefore, the tasks included in Table 10 do not duplicate the burden in Table 9. For Indian Country, there is no concomitant oversight role for the EPA and therefore Table 10 only Information Collection Request For Part 71 Operating Permit Regulations Page 24 3 June 2003 includes State and local PA oversight tasks, burdens, and costs. Estimated review numbers follow the same assumptions used for the 2000 part 70 ICR.

There is no expected capital or O& M costs for this ICR. Since the Federal government will assume many of the record keeping and monitoring requirements for tribal sources, this ICR assumes the Indian Country capital and O& M cost will be negligible. For sources in State or local areas without an approved part 70 program, this ICR assumes there will be no change in reporting requirements, and, therefore, there is no change in their capital of O& M costs.

TABLE 11 BOTTOM LINE MARGINAL BURDEN AND COST ($ 1999) 2000  2003 Number of Affected Entities Total ICR ( 3 Year) Burden Hours Average Annual Burden Per Source ( hours) Total ICR ( 3 Year) Cost Average Annual Cost Per Source Sources Permanent Program 95 45,968 161 $ 2,723,476 $ 9,556 Federal  Permanent Program 95 65,600 230 $ 2,427,200 $ 8,516 Federal  State & Local PAs* 3,084 104,368 11 $ 3,861,616 $ 417 Federal** 1 53,019 6 $ 1,827,703 $ 192 * This row represents the marginal burden for sources, beyond that required in part 70. ** The burden and cost estimates are those not already accounted for in part 70 or in prior part 71 analyses.

Tables 2, 3, and 4 display the activities of the part 70 and 71 programs for sources, permitting authorities, and the Federal government, respectively.

Tables 7, 8, and 9, and 10 display the costs associated with each of these categories. Table 11, below, summarizes the costs for all three types of affected entities in real 1999 dollars.

This ICR contains no estimated burden associated with permitting authorities other than the EPA's Federal role as the PA for the permanent Federal program. Any burden attributable to a State or local PA that does 6.4.3 Capital and O& M Costs 6.4.4 Bottom Line Burden Hours and Cost Information Collection Request For Part 71 Operating Permit Regulations Page 25 3 June 2003 not have a fully approved title V program is a component of the part 70 Operating Permits program and not applicable to this ICR.

Federal PA activities for State and local PAs represents the added inefficiency involved in the EPA managing a local program. The last row in Table 11 is not duplicative. It represents the additional burden necessary for the Agency to provide oversight and monitoring of the delegated program.

On average, the Agency estimates the burden to major sources under part 71 ( all in Indian Country) at about 46 thousand hours, or about 160 hours per year per source over the three years of the ICR. This is about half the expected burden for sources reported in the 1997 part 71 ICR and about the same burden reported in the January 2000 part 70 ICR for sources.

The burden EPA expects it will incur in its role as permitting authority has two parts. For the permanent Federal program, the Agency estimates a three year burden of about 66 thousand hours, or around 230 hours per source ( about the same as that reported in the 1997 part 71 ICR.) For its oversight of State and local PA programs in areas without a fully approved title V program, the Agency anticipates a three year burden almost twice as large: around 104 thousand hours. On an annual per source basis, this translates into about 11 hours per source more than that reported for the January 2000 part 70 ICR.

For its role in Federal oversight of all title V programs, the Agency estimates it will experience a burden of around 53 thousand hours over the life of this ICR, or about 6 hours per source per year.

The title V program has been evolving since its inception, beginning with promulgation of the part 70 regulations in 1992. Consequently, the activities associated with implementing the parts 70 and 71 programs have changed since the previous ICR. With the experience gained through program implementation, EPA and permitting authorities have a sense of the activities associated with the program and the burden of those On average, each PA can expect to spend between 70 and 80 hours each year managing and overseeing each permit application it receives, at a cost of approximately $ 2,800 per permit per year.

6.5 Reasons for Changes in the Burden Information Collection Request For Part 71 Operating Permit Regulations Page 26 3 June 2003 activities. The activities in this ICR have been developed based on this knowledge. As with the January 2000 part 70 ICR, activities are broken out into more discrete categories than in the 1997 part 71 ICR. Therefore,

comparison of the burden in this ICR to the approved burden levels in its predecessor cannot be accurately made on an activity by activity basis.

Even if they could be compared, such a comparison would be of little value because of the changing nature of the program. Such a comparison of activity categories will not have a great deal of meaning until all permits are issued and the program stabilizes in terms of activity.

The approved burden level in the previous ICR was 678 thousand hours per year for sources and 500 thousand burden hours per year for Federal oversight; for a total of 1.2 million hours. Table 12 compares the burden in the previous ICR with the burden in this ICR. The change in burden is a reduction from the previous ICR due to changes in program activities that have occurred as a result of evolution of the program. These changes are considered " adjustments" and are shown as such on OMB form 83 1.

TABLE 12 BURDEN CHANGE FROM FEBRUARY 97 ICR TO CURRENT ICR Average Annual Burden in 2 1997 ICR Average Annual Burden in ICR Renewal Difference Sources  Permanent Program 677,719 15,323 ( 652,396)

Federal 499,853 74,329 ( 425,524)

TOTAL 1,177,572 89,652 ( 1,077,920)

Hourly burden estimates decreased for sources because the largest burden category, ( preparation of initial permit applications), has already been completed for most sources. These activities will be replaced during the 3

year period of this ICR by an increase in monitoring activities, preparing and submitting semi annual monitoring reports and the annual compliance certification report, preparing permit revision applications, and preparing applications for permit renewals for some of the sources. Information Collection Request For Part 71 Operating Permit Regulations Page 27 3 June 2003 Burden means the total time, effort, and financial resources expended by persons to generate, maintain, retain, disclose, or provide information to or for a Federal agency. This includes the time needed to review instructions;

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.

Due to the large number of respondents, the variation in the circumstances for each respondent, and the varied nature of the activities of the program,

it is impractical to attempt to delineate burden by respondent and activity.

Following is the apportioned burden for each respondent, derived from the total permitting authority hourly burden divided by the number of permitting authorities, and similarly for sources.

TABLE 13 BURDEN STATEMENT Number of Respondents Total Annual Burden ( hours) Average Annual Burden per Respondent ( hours)

Sources 95 15,323 161 Federal 3,179 74,329 23 Send 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 through the use of automated collection techniques to:

Director, Collection Strategies Division Office Of Environmental Information 2822 Environmental Protection Agency 1200 Pennsylvania Ave. NW 6.6 Burden Statement Information Collection Request For Part 71 Operating Permit Regulations Page 28 3 June 2003 Washington, DC 20460 and 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.

Include the EPA ICR number ( 1713.04) and OMB control number ( 2060

0336) in any correspondence. ATTACHMENT 1 THE STATUTORY REQUIREMENTS FOR RESPONDENT INFORMATION Information Collection Request For Part 70 Operating Permit Regulations Page 30 3 June 2003 SECTIONS 502 THROUGH 504 OF TITLE V OF THE CLEAN AIR ACT SEC. 502. PERMIT PROGRAMS ( a) Violations. After the effective date of any permit program approved or promulgated under this title, it shall be unlawful for any person to violate any requirement of a permit issued under this title, or to operate an affected source ( as provided in title IV), a major source, any other source ( including an area source) subject to standards or regulations under section 111 or 112, any other source required to have a permit under parts C or D of title I, or any other stationary source in a category designated ( in whole or in part) by regulations promulgated by the Administrator ( after notice and public comment) which shall include a finding setting forth the basis for such designation,

except in compliance with a permit issued by a permitting authority under this title. ( Nothing in this subsection shall be construed to alter the applicable requirements of this Act that a permit be obtained before construction or modification.) The Administrator may, in the Administrator's discretion and consistent with the applicable provisions of this Act, promulgate regulations to exempt one or more source categories ( in whole or in part) from the requirements of this subsection if the Administrator finds that compliance with such requirements is impracticable, infeasible, or unnecessarily burdensome on such categories, except that the Administrator may not exempt any major source from such requirements.

( b) Regulations. The Administrator shall promulgate within 12 months after the date of the enactment of the Clean Air Act Amendments of 1990 regulations establishing the minimum elements of a permit program to be administered by any air pollution control agency. These elements shall include each of the following:

( 1) Requirements for permit applications, including a standard application form and criteria for determining in a timely fashion the completeness of applications.

( 2) Monitoring and reporting requirements.

( 3)( A) A requirement under State or local law or interstate compact that the owner or operator of all sources subject to the requirement to obtain a permit under this title pay an annual fee, or the equivalent over some other period, sufficient to cover all reasonable ( direct and indirect)

costs required to develop and administer the permit program requirements of this title, including section 507, including the reasonable costs of

( i) reviewing and acting upon any application for such a permit, Information Collection Request For Part 70 Operating Permit Regulations Page 31 3 June 2003 ( ii) if the owner or operator receives a permit for such source, whether before or after the date of the enactment of the Clean Air Act Amendments of 1990, implementing and enforcing the terms and conditions of any such permit ( not including any court costs or other costs associated with any enforcement action),

( iii) emissions and ambient monitoring,

( iv) preparing generally applicable regulations, or guidance,

( v) modeling, analyses, and demonstrations, and ( vi) preparing inventories and tracking emissions.

( B) The total amount of fees collected by the permitting authority shall conform to the following requirements:

( i) The Administrator shall not approve a program as meeting the requirements of this paragraph unless the State demonstrates that, except as otherwise provided in subparagraphs ( ii)

through ( v) of this subparagraph, the program will result in the collection, in the aggregate, from all sources subject to subparagraph ( A), of an amount not less than $ 25 per ton of each regulated pollutant, or such other amount as the Administrator may determine adequately reflects the reasonable costs of the permit program.

( ii) As used in this subparagraph, the term " regulated pollutant" shall mean ( I) a volatile organic compound; ( II) each pollutant regulated under section 111 or 112; and ( III) each pollutant for which a national primary ambient air quality standard has been promulgated ( except that carbon monoxide shall be excluded from this reference).

( iii) In determining the amount under clause ( i), the permitting authority is not required to include any amount of regulated pollutant emitted by any source in excess of 4,000 tons per year of that regulated pollutant.

( iv) The requirements of clause ( i) shall not apply if the permitting authority demonstrates that collecting an amount less than the amount specified under clause ( i) will meet the requirements of subparagraph ( A).

( v) The fee calculated under clause ( i) shall be increased ( consistent with the need to cover the reasonable costs authorized by subparagraph ( A)) in each year beginning after the year of the enactment of the Clean Air Act Amendments of 1990 by the percentage, if any, by which the Consumer Price Index for the most recent calendar year ending before the beginning of such year exceeds the Consumer Price Index for the calendar year 1989. For purposes of this clause

( I) the Consumer Price Index for any calendar year is the average of the Consumer Price Index for all urban consumers published by the Department of Labor, as of the close of the 12 month period ending on August 31 of each calendar year, and Information Collection Request For Part 70 Operating Permit Regulations Page 32 3 June 2003 ( II) the revision of the Consumer Price Index which is most consistent with the Consumer Price Index for calendar year 1989 shall be used.

( C)( i) If the Administrator determines, under subsection ( d), that the fee provisions of the operating permit program do not meet the requirements of this paragraph, or if the Administrator makes a determination, under subsection ( i), that the permitting authority is not adequately administering or enforcing an approved fee program, the Administrator may, in addition to taking any other action authorized under this title, collect reasonable fees from the sources identified under subparagraph ( A). Such fees shall be designed solely to cover the Administrator's costs of administering the provisions of the permit program promulgated by the Administrator.

( ii) Any source that fails to pay fees lawfully imposed by the Administrator under this subparagraph shall pay a penalty of 50 percent of the fee amount, plus interest on the fee amount computed in accordance with section 6621( a)( 2) of the Internal Revenue Code of 1986 ( relating to computation of interest on underpayment of Federal taxes).

( iii) Any fees, penalties, and interest collected under this subparagraph shall be deposited in a special fund in the United States Treasury for licensing and other services, which thereafter shall be available for appropriation, to remain available until expended, subject to appropriation, to carry out the Agency's activities for which the fees were collected. Any fee required to be collected by a State, local, or interstate agency under this subsection shall be utilized solely to cover all reasonable ( direct and indirect) costs required to support the permit program as set forth in subparagraph ( A).

( 4) Requirements for adequate personnel and funding to administer the program.

( 5) A requirement that the permitting authority have adequate authority to:

( A) issue permits and assure compliance by all sources required to have a permit under this title with each applicable standard, regulation or requirement under this Act;

( B) issue permits for a fixed term, not to exceed 5 years;

( C) assure that upon issuance or renewal permits incorporate emission limitations and other requirements in an applicable implementation plan;

( D) terminate, modify, or revoke and reissue permits for cause;

( E) enforce permits, permit fee requirements, and the requirement to obtain a permit,

including authority to recover civil penalties in a maximum amount of not less than $ 10,000 per day for each violation, and provide appropriate criminal penalties; and ( F) assure that no permit will be issued if the Administrator objects to its issuance in a timely manner under this title.

( 6) Adequate, streamlined, and reasonable procedures for expeditiously determining when applications are complete, for processing such applications, for public notice, including offering an opportunity for public comment and a hearing, and for expeditious review of permit actions, including Information Collection Request For Part 70 Operating Permit Regulations Page 33 3 June 2003 applications, renewals, or revisions, and including an opportunity for judicial review in State court of the final permit action by the applicant, any person who participated in the public comment process, and any other person who could obtain judicial review of that action under applicable law.

( 7) To ensure against unreasonable delay by the permitting authority, adequate authority and procedures to provide that a failure of such permitting authority to act on a permit application or permit renewal application ( in accordance with the time periods specified in section 503 or, as appropriate, title IV) shall be treated as a final permit action solely for purposes of obtaining judicial review in State court of an action brought by any person referred to in paragraph ( 6) to require that action be taken by the permitting authority on such application without additional delay.

( 8) Authority, and reasonable procedures consistent with the need for expeditious action by the permitting authority on permit applications and related matters, to make available to the public any permit application, compliance plan, permit, and monitoring or compliance report under section 503( e), subject to the provisions of section 114( c) of this Act.

( 9) A requirement that the permitting authority, in the case of permits with a term of 3 or more years for major sources, shall require revisions to the permit to incorporate applicable standards and regulations promulgated under this Act after the issuance of such permit. Such revisions shall occur as expeditiously as practicable and consistent with the procedures established under paragraph ( 6) but not later than 18 months after the promulgation of such standards and regulations. No such revision shall be required if the effective date of the standards or regulations is a date after the expiration of the permit term. Such permit revision shall be treated as a permit renewal if it complies with the requirements of this title regarding renewals.

( 10) Provisions to allow changes within a permitted facility ( or one operating pursuant to section 503( d)) without requiring a permit revision, if the changes are not modifications under any provision of title I and the changes do not exceed the emissions allowable under the permit ( whether expressed therein as a rate of emissions or in terms of total emissions: Provided, That the facility provides the Administrator and the permitting authority with written notification in advance of the proposed changes which shall be a minimum of 7 days, unless the permitting authority provides in its regulations a different timeframe for emergencies.

( c) Single Permit. A single permit may be issued for a facility with multiple sources.

( d) Submission and Approval. ( 1) Not later than 3 years after the date of the enactment of the Clean Air Act Amendments of 1990, the Governor of each State shall develop and submit to the Administrator a permit program under State or local law or under an interstate compact meeting the requirements of this title. In addition, the Governor shall submit a legal opinion from the attorney general ( or the attorney for those State air pollution control agencies that have independent legal counsel), or from the chief legal officer of an interstate agency, that the laws of the State, locality, Information Collection Request For Part 70 Operating Permit Regulations Page 34 3 June 2003 or the interstate compact provide adequate authority to carry out the program. Not later than 1 year after receiving a program, and after notice and opportunity for public comment, the Administrator shall approve or disapprove such program, in whole or in part. The Administrator may approve a program to the extent that the program meets the requirements of this Act, including the regulations issued under subsection ( b). If the program is disapproved, in whole or in part, the Administrator shall notify the Governor of any revisions or modifications necessary to obtain approval. The Governor shall revise and resubmit the program for review under this section within 180 days after receiving notification.

( 2)( A) If the Governor does not submit a program as required under paragraph ( 1) or if the Administrator disapproves a program submitted by the Governor under paragraph ( 1), in whole or in part, the Administrator may, prior to the expiration of the 18 month period referred to in subparagraph ( B), in the Administrator's discretion, apply any of the sanctions specified in section 179( b).

( B) If the Governor does not submit a program as required under paragraph ( 1), or if the Administrator disapproves any such program submitted by the Governor under paragraph ( 1), in whole or in part, 18 months after the date required for such submittal or the date of such disapproval,

as the case may be, the Administrator shall apply sanctions under section 179( b) in the same manner and subject to the same deadlines and other conditions as are applicable in the case of a determination, disapproval, or finding under section 179( a).

( C) The sanctions under section 179( b)( 2) shall not apply pursuant to this paragraph in any area unless the failure to submit or the disapproval referred to in subparagraph ( A) or ( B) relates to an air pollutant for which such area has been designated a nonattainment area ( as defined in part D of title I).

( 3) If a program meeting the requirements of this title has not been approved in whole for any State, the Administrator shall, 2 years after the date required for submission of such a program under paragraph ( 1), promulgate, administer, and enforce a program under this title for that State.

( e) Suspension. The Administrator shall suspend the issuance of permits promptly upon publication of notice of approval of a permit program under this section, but may, in such notice,

retain jurisdiction over permits that have been federally issued, but for which the administrative or judicial review process is not complete. The Administrator shall continue to administer and enforce federally issued permits under this title until they are replaced by a permit issued by a permitting program. Nothing in this subsection should be construed to limit the Administrator's ability to enforce permits issued by a State.

( f) Prohibition. No partial permit program shall be approved unless, at a minimum, it applies, and ensures compliance with, this title and each of the following: Information Collection Request For Part 70 Operating Permit Regulations Page 35 3 June 2003 ( 1) All requirements established under title IV applicable to " affected sources."

( 2) All requirements established under section 112 applicable to " major sources", " area sources," and " new sources."

( 3) All requirements of title I ( other than section 112) applicable to sources required to have a permit under this title. Approval of a partial program shall not relieve the State of its obligation to submit a complete program, nor from the application of any sanctions under this Act for failure to submit an approvable permit program.

( g) Interim Approval. If a program ( including a partial permit program) submitted under this title substantially meets the requirements of this title, but is not fully approvable, the Administrator may by rule grant the program interim approval. In the notice of final rulemaking, the Administrator shall specify the changes that must be made before the program can receive full approval. An interim approval under this subsection shall expire on a date set by the Administrator not later than 2 years after such approval, and may not be renewed. For the period of any such interim approval, the provisions of subsection ( d)( 2), and the obligation of the Administrator to promulgate a program under this title for the State pursuant to subsection ( d)( 3), shall be suspended. Such provisions and such obligation of the Administrator shall apply after the expiration of such interim approval.

( h) Effective Date. The effective date of a permit program, or partial or interim program,

approved under this title, shall be the effective date of approval by the Administrator. The effective date of a permit program, or partial permit program, promulgated by the Administrator shall be the date of promulgation.

( i) Administration and Enforcement. ( 1) Whenever the Administrator makes a determination that a permitting authority is not adequately administering and enforcing a program,

or portion thereof, in accordance with the requirements of this title, the Administrator shall provide notice to the State and may, prior to the expiration of the 18 month period referred to in paragraph ( 2), in the Administrator's discretion, apply any of the sanctions specified in section 179( b).

( 2) Whenever the Administrator makes a determination that a permitting authority is not adequately administering and enforcing a program, or portion thereof, in accordance with the requirements of this title, 18 months after the date of the notice under paragraph ( 1), the Administrator shall apply the sanctions under section 179( b) in the same manner and subject to the same deadlines and other conditions as are applicable in the case of a determination, disapproval, or finding under section 179( a).

( 3) The sanctions under section 179( b)( 2) shall not apply pursuant to this subsection in any area unless the failure to adequately enforce and administer the program relates to an air pollutant for which such area has been designated a nonattainment area. Information Collection Request For Part 70 Operating Permit Regulations Page 36 3 June 2003 ( 4) Whenever the Administrator has made a finding under paragraph ( 1) with respect to any State, unless the State has corrected such deficiency within 18 months after the date of such finding,

the Administrator shall, 2 years after the date of such finding, promulgate, administer, and enforce a program under this title for that State. Nothing in this paragraph shall be construed to affect the validity of a program which has been approved under this title or the authority of any permitting authority acting under such program until such time as such program is promulgated by the Administrator under this paragraph. [ 42 U. S. C. 7661a]

SEC. 503. PERMIT APPLICATIONS.

( a) APPLICABLE DATE. Any source specified in section 502( a) shall become subject to a permit program, and required to have a permit, on the later of the following dates

( 1) the effective date of a permit program or partial or interim permit program applicable to the source; or ( 2) the date such source becomes subject to section 502( a).

( b) COMPLIANCE PLAN.( 1) The regulations required by section 502( b) shall include a requirement that the applicant submit with the permit application a compliance plan describing how the source will comply with all applicable requirements under this Act. The compliance plan shall include a schedule of compliance, and a schedule under which the permittee will submit progress reports to the permitting authority no less frequently than every 6 months.

( 2) The regulations shall further require the permittee to periodically ( but no less frequently than annually) certify that the facility is in compliance with any applicable requirements of the permit,

and to promptly report any deviations from permit requirements to the permitting authority.

( c) DEADLINE. Any person required to have a permit shall, not later than 12 months after the date on which the source becomes subject to a permit program approved or promulgated under this title, or such earlier date as the permitting authority may establish, submit to the permitting authority a compliance plan and an application for a permit signed by a responsible official, who shall certify the accuracy of the information submitted. The permitting authority shall approve or disapprove a completed application ( consistent with the procedures established under this title for consideration of such applications), and shall issue or deny the permit, within 18 months after the date of receipt thereof, except that the permitting authority shall establish a phased schedule for acting on permit applications submitted within the first full year after the effective date of a permit program ( or a partial or interim program). Any such schedule shall assure that at least one third of such permits will be acted on by such authority annually over a period of not to exceed 3 years after such effective Information Collection Request For Part 70 Operating Permit Regulations Page 37 3 June 2003 date. Such authority shall establish reasonable procedures to prioritize such approval or disapproval actions in the case of applications for construction or modification under the applicable requirements of this Act.

( d) TIMELY AND COMPLETE APPLICATIONS. Except for sources required to have a permit before construction or modification under the applicable requirements of this Act, if an applicant has submitted a timely and complete application for a permit required by this title ( including renewals), but final action has not been taken on such application, the source's failure to have a permit shall not be a violation of this Act, unless the delay in final action was due to the failure of the applicant timely to submit information required or requested to process the application. No source required to have a permit under this title shall be in violation of section 502( a) before the date on which the source is required to submit an application under subsection ( c).

( e) COPIES; AVAILABILITY. A copy of each permit application, compliance plan ( including the schedule of compliance), emissions or compliance monitoring report, certification, and each permit issued under this title, shall be available to the public. If an applicant or permittee is required to submit information entitled to protection from disclosure under section 114( c) of this Act,

the applicant or permittee may submit such information separately. The requirements of section 114( c) shall apply to such information. The contents of a permit shall not be entitled to protection under section 114( c).

SEC. 504. PERMIT REQUIREMENTS AND CONDITIONS.

( a) CONDITIONS. Each permit issued under this title shall include enforceable emission limitations and standards, a schedule of compliance, a requirement that the permittee submit to the permitting authority, no less often than every 6 months, the results of any required monitoring, and such other conditions as are necessary to assure compliance with applicable requirements of this Act,

including the requirements of the applicable implementation plan.

( b) MONITORING AND ANALYSIS. The Administrator may by rule prescribe procedures and methods for determining compliance and for monitoring and analysis of pollutants regulated under this Act, but continuous emissions monitoring need not be required if alternative methods are available that provide sufficiently reliable and timely information for determining compliance. Nothing in this subsection shall be construed to affect any continuous emissions monitoring requirement of title IV, or where required elsewhere in this Act.

( c) INSPECTION, ENTRY, MONITORING, CERTIFICATION, AND REPORTING. Each permit issued under this title shall set forth inspection, entry, monitoring, compliance certification,

and reporting requirements to assure compliance with the permit terms and conditions. Such Information Collection Request For Part 70 Operating Permit Regulations Page 38 3 June 2003 monitoring and reporting requirements shall conform to any applicable regulation under subsection ( b). Any report required to be submitted by a permit issued to a corporation under this title shall be signed by a responsible corporate official, who shall certify its accuracy.

§ 70.5( c) Standard applications form and required information. The State program under this part shall provide for a standard application form or forms. Information as described below for each emissions unit at a part 70 source shall be included in the application. The Administrator may approve as part of a State program a list of insignificant activities and emissions levels which need not be included in permit applications. However, for insignificant activities which are exempted because of size or production rate, a list of such insignificant activities must be included in the application. An application may not omit information needed to determine the applicability of, or to impose, any applicable requirement, or to evaluate the fee amount required under the schedule approved pursuant to § 70.9 of this part. The permitting authority may use discretion in developing application forms that best meet program needs and administrative efficiency. The forms and attachments chosen, however,

shall include the elements specified below:

( 1) Identifying information, including company name and address ( or plant name and address if different from the company name), owner's name and agent, and telephone number and names of plant site manager/ contact.

( 2) A description of the source's processes and products ( by Standard Industrial Classification Code) including any associated alternative scenario identified by the source.

( 3) The following emission related information:

( i) All emissions of pollutants for which the source is major, and all emissions of regulated air pollutants. A permit application shall describe all emissions of regulated air pollutants emitted from any emissions unit, except where such units are exempted under this paragraph ( c) of this section. The permitting authority shall require additional information related to the emissions of air pollutants sufficient to verify which requirements are applicable to the source, and other information necessary to collect any permit fees owed under the fee schedule approved pursuant to § 70.9( b) of this part.

( ii) Identification and description of all points of emissions described in paragraph ( c)( 3)( i)

of this section in sufficient detail to establish the basis for fees and applicability of requirements of the Act.

( iii) Emissions rate in tpy and in such terms as are necessary to establish compliance consistent with the applicable standard reference test method.

( iv) The following information to the extent it is needed to determine to regulate emissions:

Fuels, fuel use, raw materials, production rates, and operating schedules. Information Collection Request For Part 70 Operating Permit Regulations Page 39 3 June 2003 ( v) Identification and description of air pollution control equipment and compliance monitoring devices or activities.

( vi) Limitations on source operation affecting emissions or any work practice standards,

where applicable, for all regulated pollutants at the part 70 source.

( vii) Other information required by any applicable requirement ( including information related to stack height limitations developed pursuant to section 123 of the Act.)

( viii) Calculations on which the information on paragraphs ( c)( 3)( i) through ( c)( 3)( vii) of this section is based.

( 4) The following air pollution control requirements:

( i) Citation and description of all applicable requirements, and ( ii) Description of or reference to any applicable test method for determining compliance with each applicable requirement.

( 5) Other specific information that may be necessary to implement and enforce other applicable requirements of the Act or of this part or to determine the applicability of such requirements.

( 6) An explanation of any proposed exemptions from otherwise applicable requirements.

( 7) Additional information as determined to be necessary by the permitting authority to define alternative operating scenarios identified by the source pursuant to § 70.6( a)( 9) of this part or to define permit terms and conditions implementing § 70.4( b)( 12) or § 70.6( a)( 10) of this part.

( 8) A compliance plan for all part 70 sources that contains all the following:

( i) A description of the compliance status of the source with respect to all applicable requirements.

( ii) A description as follows:

( A) For applicable requirements with which the source is in compliance, a statement that the source will continue to comply with such requirements.

( B) For applicable requirements that will become effective during the permit term, a statement that the source will meet such requirements on a timely basis.

( C) For requirements for which the source is not in compliance at the time or permit issuance,

a narrative description of how the source will achieve compliance with such requirements.

( iii) A compliance schedule as follows:

( A) For applicable requirements with which the source is in compliance, a statement that the source will continue to comply with such requirements.

( B) For applicable requirements that will become effective during the permit term, a statement that the source will meet such requirements on a timely basis. A statement that the source will meet in a timely manner applicable requirements that become effective during the permit term Information Collection Request For Part 70 Operating Permit Regulations Page 40 3 June 2003 shall satisfy this provision, unless a more detailed schedule is expressly required by the applicable requirement.

( C) A schedule of compliance for sources that are not in compliance with all applicable requirements at the time of permit issuance. Such a schedule shall include a schedule of remedial measures, including an enforceable sequence of actions with milestones, leading to compliance with any applicable requirements for which the source will be in noncompliance at the time of permit issuance. This compliance schedule shall resemble and be at least as stringent as that contained in any judicial consent decree or administrative order to which the source is subject. Any such schedule of compliance shall be supplemental to and shall not sanction noncompliance with, the applicable requirements on which it is based.

( iv) A schedule for submission of certified progress reports no less frequently than every 6 months for sources required to have a schedule of compliance to remedy a violation.

( v) The compliance plan content requirements specified in this paragraph shall apply and be included in the acid rain portion of a compliance plan for an affected source, except as specifically superseded by regulations promulgated under title IV of the Act with regard to the schedule and method( s) the source will use to achieve compliance with the acid rain emissions limitations.

( 9) Requirements for compliance certification, including the following:

( i) A certification of compliance with all applicable requirements by a responsible official consistent with paragraph ( d) of this section and section 114( a)( 3) of the Act;

( ii) A statement of methods used for determining compliance, including a description of monitoring, recordkeeping, and reporting requirements and test methods;

( iii) A schedule for submission of compliance certifications during the permit term, to be submitted no less frequently than annually, or more frequently if specified by the underlying applicable requirement or by the permitting authority; and ( iv) A statement indicating the source's compliance status with any applicable enhanced monitoring and compliance certification requirements of the Act.

( 10) The use of nationally standardized forms for acid rain portions of permit applications and compliance plans, as required by regulations promulgated under title IV of the Act.

( d) Any application form, report, or compliance certification submitted pursuant to these regulations shall contain certification by a responsible official of truth, accuracy, and completeness.

This certification and any other certification required under this part shall state that, based on information and belief formed after reasonable inquiry, the statements and information in the document are true, accurate, and complete. ATTACHMENT 2 OCTOBER 18, 1999 FEDERAL REGISTER NOTICE Information Collection Request For Part 70 Operating Permit Regulations Page 44 3 June 2003


[Federal Register Volume 81, Number 106 (Thursday, June 2, 2016)]
[Notices]
[Page 35362]
[FR Doc No: 2016-12942]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Collaborating To Strengthen Food, Drug, and Medical Device Safety
Systems; Notice of Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of conference.

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SUMMARY:  The Food and Drug Administration (FDA) Philadelphia District
Office, in co-sponsorship with the Association of Food and Drug
Officials (AFDO), and the North Central Association of Food and Drug
Officials, is announcing a conference entitled ``Collaborating to
Strengthen Food, Drug, and Medical Device Safety Systems.'' This
conference is intended to provide information about FDA drug and device
regulation to the regulated industry.

DATES:  The conference will be held on June 25 to June 29, 2016. See
SUPPLEMENTARY INFORMATION for meeting times.

ADDRESSES:  The Omni William Penn Hotel, 530 William Penn Pl.,
Pittsburgh, PA 15219. Attendees are responsible for their own
accommodations.

FOR FURTHER INFORMATION CONTACT:  Randy Young, Association of Food and
Drug Officials, 2550 Kingston Rd., Suite 311, York, PA 17402, 717-757-
2888, FAX:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:  FDA has made education of the food, feed,
drug, and device manufacturing community a high priority to help ensure
the quality of FDA-regulated products. The conference helps to achieve
objectives set forth in section 406 of the Food and Drug Administration
Modernization Act of 1997 (21 U.S.C. 393), which includes working
closely with stakeholders and maximizing the availability and clarity
of information for stakeholders and the public. The conference also is
consistent with the Small Business Regulatory Enforcement Fairness Act
of 1996 (Pub. L. 104-121), as outreach activities by government
Agencies to small businesses.
    The conference helps fulfill the U.S. Department of Health and
Human Services' and FDA's important mission to protect the public
health. The conference will provide FDA-regulated drug and device
entities with information on a number of topics concerning FDA
requirements related to the production and marketing of drugs and/or
devices. Topics for discussion include, but are not limited to the
following:

 FDA Program Alignment
 Recalls from the Perspective of the District
 Inspection of Licensed Producers under the Marijuana for
Medical Purposes Regulations (Health Canada)
 Foreign inspections
 Regulatory Intelligence
 FDA Inspections: Challenges and Opportunities (Working
Luncheon)
 Drug Shortages
 Drug Supply Chain Act: Wholesale Drug Distributor and 3rd
Party Logistics Provider
 Medical Device Single Audit Program
 Compliance Questions Panel

    The Conference Web site is: http://afdo.org/conference. The meeting
times are as follows:

------------------------------------------------------------------------
                Date                             Meeting time
------------------------------------------------------------------------
June 25.............................  8 a.m. to 5 p.m.
June 26.............................  8 a.m. to 6 p.m.
June 27.............................  8 a.m. to 5:30 p.m.
June 28.............................  8 a.m. to 5 p.m.
June 29.............................  8 a.m. to 11:30 a.m.
------------------------------------------------------------------------

    Registration: The AFDO registration fees cover the cost of
facilities, materials, and breaks. Seats are limited and registration
will close after the course is filled; therefore, please submit your
registration as soon as possible. Conference space will be filled in
order of receipt of registration; those accepted will receive
confirmation. Registration at the site is not guaranteed but may be
possible on a space available basis on the day of the conference,
beginning at 7:30 a.m. The cost of registration follows:

------------------------------------------------------------------------
                                                               Cost of
                         Category                           registration
------------------------------------------------------------------------
Member....................................................          $475
Non-Member................................................           575
Additional Fee for Registration Postmarked After June 1,             100
 2016.....................................................
------------------------------------------------------------------------

    To register, please complete and submit an AFDO conference
registration form, available at http://pitt.afdo.org/registration.html,
along with a check, money order payable to ``AFDO''; the registrar will
also accept Visa and MasterCard credit cards. Please mail your
completed registration form and payment to: AFDO, 2550 Kingston Rd.,
Suite 311, York, PA 17402. To register online, please visit http://pitt.afdo.org/registration.html (FDA has verified the Web site address,
but is not responsible for subsequent changes to the Web site after
this document publishes in the Federal Register.) For more information
on the conference, or for questions about registration, please contact
Randy Young (see FOR FURTHER INFORMATION CONTACT), email inquiries will
also be accepted at<EMAIL_ADDRESS>or visit http://www.afdo.org.
    If you need special accommodations due to a disability, please
contact Randy Young (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the conference.

    Dated: May 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12942 Filed 6-1-16; 8:45 am]
 BILLING CODE 4164-01-P