1 PART A OF THE SUPPORTING STATEMENT 1. Identification of the Information Collection ( a) Title and Number of the Information Collection " Reporting and Recordkeeping Requirements for the National Emissions Standards for Hazardous Air Pollutants for Amino/ Phenolic Resins Production." This is a new information collection request ( ICR), and the U. S. Environmental Protection Agency ( EPA) tracking number for this ICR is 1869.02. ( b) Short Characterization ( i) Applicability: Respondents are owners and operators of new and existing facilities that engage in the manufacture of amino/ phenolic resins and emit hazardous air pollutants ( HAP's). Forty facilities are expected to meet the applicability criteria defined in the final rule. No new facilities are expected to be constructed in the next 5 years. For this reason, burden estimates have not been made for new facilities. ( ii) Amino/ Phenolic Resins Production Facilities: Owners or operators of amino/ phenolic resins production facilities to which this regulation is applicable must choose one of the compliance options described in the proposed rule, which may include installing and monitoring a specific control system that reduces HAP emissions to the compliance level. The respondents would be subject to follow sections of subpart A of 40 CFR part 63 relating to NESHAP. These requirements include those associated with the notification of compliance status for the first 5 months, and semiannually thereafter. Respondents electing to comply with the emission limit or emission reduction requirements as described in the final rule for batch process vents or storage vessels must record the following: daily or monthly average values of equipment operating parameters and/ or process information specified to be monitored. The recorded parameters shall be calculated as described in § 63.1415 of the final rule. ( iii) Record Retention: Owners or operators of amino/ phenolic resins manufacturing facilities must maintain a copy of all specified records onsite for a minimum of 5 years. All records are to be submitted upon request to EPA or the respondent's State or local agency, whichever has been delegated enforcement authority by EPA. The information is used to determine whether or not facilities subject to the NESHAP are achieving the standards. ( iv) Reports: The general recordkeeping and reporting requirements of this subpart are very similar to those found in the HON. The final rule also relies on the provisions of subpart A of 40 CFR part 63. A table included in the final rule designates which sections of subpart A apply to the final rule. Specific recordkeeping and reporting requirements for each type of emission point are also included in the final rule. The final rule references the recordkeeping and reporting requirements from the Hazardous Organic NESHAP ( HON) for continuous process vents, storage vessels, and equipment leaks. 2 The following reports must be submitted to the Administrator as appropriate: ( 1) Precompliance Report, ( 2) Notification of Compliance Status, ( 3) Periodic Reports, and ( 4) Other Reports. The requirements for each of the four reports are summarized in the final rule. In addition, sources complying with the equipment leak requirements, which reference 40 CFR part 63, subpart H, must follow the recordkeeping and reporting requirements of 40 CFR part 63, subpart H. 2. Need For and Use of the Collection The EPA is required under section 112( d) of the Clean Air Act ( the Act) to regulate emissions of HAP's listed in section 112( b). The predominant HAP's emitted from amino/ phenolic resins production include formaldehyde, methanol, and phenol. In the Administrator's judgement, the pollutants emitted from amino/ phenolic resins production facilities cause or contribute significantly to air pollution that may reasonably be anticipated to endanger public health. Therefore, this source category was listed for regulation under section 112. Certain records and reports are necessary to enable the Administrator to identify facilities subject to the standard and to ensure that the standard, which is based on maximum achievable control technology ( MACT) specific to amino/ phenolic resins facilities, is being achieved. All respondents must submit a semiannual report of compliance for batch process vents, storage vessels, and equipment leaks to the EPA that contains all the information requested in § 63.1417 of the final rule. These records and reports are required under the General Provisions of 40 CFR part 63, subpart A ( as authorized under sections 101, 112, 114, 116, and 301 of the Act as amended by Pub. L 101 549 [ 42 U. S. C. 7401, 7412, 7414, 7416, 7601]). ( a) Practical Utility/ Users of the Data The information will be used by Agency enforcement personnel to ( 1) identify new, modified, reconstructed, and existing facilities subject to the standards; and ( 2) ensure that MACT is being properly applied and that compliance is being maintained and documented. In addition, records and reports are necessary to enable the Agency to identify facilities that are not in compliance with the standards. Based on reported information, the EPA can decide which facilities should be inspected and what records or processes should be inspected at these facilities. The records that facilities maintain would indicate to EPA whether the owners or operators are in compliance with the standards. Much of the information the EPA would need to determine compliance would be recorded and compiled monthly. Such information would be reviewed by enforcement personnel during an inspection. 3. The Respondents and the Information Requested ( a) Respondents/ SIC Code Respondents are owners or operators of amino/ phenolic resins production facilities that are classified as major sources under section 112 of CAA. The primary SIC code for the respondents affected by the rule is 2821 ( plastic materials and resins). 3 ( b) Information Requested ( i) Data items: Attachment 1, Source Data and Information Requirements, summarizes the recordkeeping and reporting requirements. ( ii) Respondent activities: The respondent activities required by the standards in the first 3 years following the effective date are listed in the first columns of Tables 1a and 1b, which are presented in section 6( a). Individual tables for each of the first 2 years after the effective date were developed because the annual burden varied between the first and second year. The third year burden is expected to be identical to the second year burden. 4. Information Collected Agency Activities, Collection Methodology, and Information Management ( a) Agency Activities Agency activities for the first 3 years following the effective date of the standards are provided in Tables 2a and 2b, and are discussed in section 6c. Individual tables for the first 2 years after the effective date were developed because the annual burden varied between the first and second year. The third year burden is expected to be identical to the second year burden. ( b) Collection Methodology and Management Information contained in the initial, one time only reports will be entered in the Aerometric Information Retrieval System ( AIRS) Facility Subsystem operated and maintained by the Agency's Office of Air Quality Planning and Standards. Data obtained during periodic visits by Agency personnel, from records maintained by the respondents, and from information provided in semiannual reports will be tabulated and published for internal EPA use in compliance and enforcement programs. The regulation does not require the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Although many of the large companies have elaborate collection methods, automated systems are not expected to reduce the burden. ( c) Small Entity Flexibility Eleven of the 40 affected facilities in this source category are owned by small businesses as defined by the Small Business Administration ( SBA). The Agency does not expect that any amino/ phenolic resins production facilities, including the small businesses, would experience more than minimal adverse impacts related to the cost of the required reporting and recordkeeping. ( d) Collection Schedule For all existing facilities, the initial Notification of Compliance Status must be submitted within 5 months of the effective date of this standard. Records necessary to determine compliance would be compiled on a monthly basis and notifications of compliance status would be submitted to the Administrator on a semiannual basis. 5. Nonduplication, Consultations, and Other Collection Criteria ( a) Nonduplication 4 Certain reports required by State or local agencies may duplicate information required by the rule. In such cases, a copy of the report submitted to the State or local agency can be provided to the Administrator in lieu of the report required by the rule. ( b) Consultations The EPA advised interested parties on July 16, 1992 ( 57 FR 31576) of the categories considered as sources of HAP's, and " Amino and Phenolic Resins Production" was listed as a category of major sources. No specific information was provided with respect to burden estimates at that time. Representatives from other interested EPA offices and programs, including State and Regional environmental agency personnel, participated in the regulatory development and were given opportunities to review and comment on the rule before proposal. Therefore, the EPA believes that the implication to other EPA offices and programs was adequately considered during the development of the proposed rule. In addition, the EPA has met with some members of industry concerning the proposed rule. Finally, industry, regulatory authorities, and environmental groups had the opportunity to comment on the rule and provide additional information during the public comment period following proposal. No public comments were received regarding any aspect of the information collection. ( c) Effects of Less Frequent Collection If the relevant information were collected less frequently by the owner or operator, the EPA would not be reasonably assured that a facility is in compliance with the standards. Less frequent collection could result in longterm exceedances of the applicable emission limits. This reporting frequency is consistent with the requirements of title V permit programs. Consequently, less frequent reports would not result in a lower burden. ( d) General Guidelines This ICR requires that amino/ phenolic resins production facilities retain records of control device monitoring or HAP emissions calculations records at facilities for a period of 5 years, which exceeds the 3 year retention period contained in the guidelines in 5 CFR 1320.5; however, the 5 year period is consistent with the General Provisions to 40 CFR part 63 and the permit requirements under 40 CFR part 70. All facilities subject to this rule will be required to obtain operating permits either through the State approved permitting program or, if one does not exist, in accordance with the provisions of 40 CFR part 71, when promulgated. None of the other guidelines in 4 CFR 1320.6 are being exceeded. ( e) Confidentiality All information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, Chapter 1, Part 2, Subpart B Confidentiality of Business Information ( see 40 CFR part 2; 41 FR 36902, September 1, 1976; amended by 43 FR 39999, September 8, 1978; 43 FR 42251, September 28, 1978; 44 FR 17674, March 23, 1979). 5 6. Estimating the Burden and Cost of the Collection ( a) Estimating Respondent Burden The annual burden estimates for reporting and recordkeeping activities are presented in Tables 1a and 1b. Individual tables for the first 2 years after the effective date were developed because the annual burden varied between the first and second year. The third year burden is expected to be identical to the second year burden. The burden estimates in each table were derived from estimates based on the Agency's experience with other standards. These costs represent the average burden that will be incurred by facilities and the entire industry in the first 3 years after the standards go into effect. ( b) Estimating Respondent Costs Labor costs for the information collection activities at amino/ phenolic resins production facilities are also presented in Tables 1a and 1b. Labor rates and associated costs are based on estimated hourly rates of technical at $ 45, management at $ 67, and clerical at $ 21. TABLE 1a. ESTIMATED ANNUAL BURDEN AND LABOR COST TO INDUSTRY TO IMPLEMENT REPORTING AND RECORDKEEPING REQUIREMENTS  FIRST YEAR 6 Burden Item ( A)

Person hours per occurrence ( B) Number of occurrences per year ( C) Person hrs. per respondent per year ( C= A* B) ( D) Respondents per year ( E) Technical person  hrs.

per year ( E= C* D) ( F) Management person hrs. per year ( F= E* 0.05) ( G) Clerical person hrs.

per year ( G= E* 0.1) ( H) Annual costs ($ 1000/ yr)

1.0 Read Rule and Instructions 60 1 60 40 2400 120 240 121.1 2.0 Plan Activities 80 1 80 40 3200 160 320 161.4 3.0 Training 32 1 32 40 1280 64 128 64.6 4.0 Create, Test, and Research and Development 320 1 320 40 12800 640 1280 645.8 5.0 Gather Information,

Monitor, and Inspect 208 1 208 40 8320 416 832 419.7 6.0 Process/ Compile and Review 48 2 96 40 3840 192 384 193.7 7.0 Complete Reports 40 2 80 40 3200 160 320 161.4 8.0 Record/ Disclose 16 2 32 40 1280 64 128 64.6 9.0 Store/ File 4 2 8 40 320 16 32 16.1 10.0 LDAR Reporting and Recordkeeping a 200 b 340 1 1 200 340 25 2 5680 284 568 286.6 11.0 Capital Costs of Monitoring and Recordkeeping Equipment 80.0 TOTAL BURDEN ( HRS) AND COSTS 42320 2116 4232 2215.0 a Less than 500 components b Greater than 500 components TABLE 1b. ESTIMATED ANNUAL BURDEN AND LABOR COST TO INDUSTRY TO IMPLEMENT REPORTING AND RECORDKEEPING REQUIREMENTS  SECOND AND THIRD YEAR 7 Burden Item ( A)

Person hours per occurrence ( B) Number of occurrences per year ( C) Person hrs. per respondent per year ( C= A* B) ( D) Respondents per year ( E) Technical person  hrs.

per year ( E= C* D) ( F) Management person hrs. per year ( F= E* 0.05) ( G) Clerical person hrs.

per year ( G= E* 0.1) ( H) Annual costs ($ 1000/ yr)

1.0 Read Rule and Instructions 16 1 16 40 640 32 64 32.3 2.0 Plan Activities 8 1 8 40 320 16 32 16.1 3.0 Training 16 1 16 40 640 32 64 32.3 4.0 Create, Test, and Research and Development 320 1 320 2 640 32 64 32.3 5.0 Gather Information,

Monitor, and Inspect 208 1 208 40 8320 416 832 419.7 6.0 Process/ Compile and Review 48 2 96 40 3840 192 384 193.7 7.0 Complete Reports 40 2 80 40 3200 160 320 161.4 8.0 Record/ Disclose 16 2 32 40 1280 64 128 64.6 9.0 Store/ File 4 2 8 40 320 16 32 16.1 10.0 LDAR Reporting and Recordkeeping a 60 b 104 1 1 60 104 25 2 1708 85 171 86.1 11.0 Capital Costs of Monitoring and Recordkeeping Equipment TOTAL BURDEN ( HRS)

AND COSTS 20908 1045 2091 1054.8 a Less than 500 components b Greater than 500 components 8 It was assumed that a pH monitor and a liquid flow monitor would be included as components of the scrubber because they are necessary for the proper operation and maintenance of a scrubber. Capital costs for these devices are included in the control costs and not as a component of the information collection costs. Therefore, capital costs for information collection at amino/ phenolic resins production facilities are only associated with the purchase of a desktop computer to be used for compiling monitoring data. The capital costs, assumed to be a one time cost for the life of the equipment, were estimated to be $ 2,000 per source. Total costs for the first year for 40 facilities are $ 80,000.

( c) Estimating Agency Burden and Costs Because the information collection requirements were estimated as an incidental part of standards development, no costs can be attributed to the development of the information collection requirements. Because reporting and recordkeeping requirements on the part of the respondents are required under section 112 of the Act, no operational costs will be incurred by the Federal Government. Publication and distribution of the information are part of AIRS,

with the result that no Federal costs can be attributed to the ICR.

Examination of records to be maintained by the respondents will occur incidentally as part of the periodic inspection of sources that is part of the Agency's overall compliance and enforcement program and, therefore, is not attributable to the ICR.

The only costs that the Federal Government will incur are user costs associated with the analysis of the information reported semiannually by the 9 sources, ( unless the semiannual reports indicate a violation, thereby triggering an enforcement action) as presented in Tables 2a and 2b. TABLE 2a. ESTIMATE OF ANNUAL BURDEN AND COST TO THE FEDERAL GOVERNMENT TO IMPLEMENT REPORTING AND RECORDKEEPING REQUIREMENTS  FIRST YEAR 10 Burden Item ( A) Person hours per activity ( B) Number of activities per year ( C) Technical person hours per year ( C= A* B) ( D) Management person hours per year ( D= C* 0.05) ( E) Clerical person hours per year ( E= C* 0.1) ( F) Annual costs ($ 1000/ yr)

1.0 Initial performance and test 20 40 800 40 80 40.4 2.0 Repeat performance test N/ A 3.0 Litigation N/ A 4.0 Report review a) notification of const./ reconst. N/ A b) notif. of anticipated startup N/ A c) notif. of actual startup N/ A d) notif. of modification N/ A e) notif. of compliance status 8 40 320 16 32 16.1 f) notif. of performance test 4 40 160 8 16 8.1 g) notif. of process change N/ A h) notif. of inspection of storage vessel N/ A I) notif. of change in primary product N/ A j) precompliance report 8 40 320 16 32 16.1 k) storage vessel initial compliance demonstration N/ A l) periodic reports of compliance status 4 80 320 16 32 16.1 TABLE 2a. ESTIMATE OF ANNUAL BURDEN AND COST TO THE FEDERAL GOVERNMENT TO IMPLEMENT REPORTING AND RECORDKEEPING REQUIREMENTS  FIRST YEAR 11 TOTAL BURDEN ( HRS) AND COSTS 1920 96 192 96.9 TABLE 2b. ESTIMATE OF ANNUAL BURDEN AND COST TO THE FEDERAL GOVERNMENT TO IMPLEMENT REPORTING AND RECORDKEEPING REQUIREMENTS  SECOND AND THIRD YEARS 12 Burden Item ( A) Person hours per activity ( B) Number of activities per year ( C) Technical person hours per year ( C= A* B) ( D) Management person hours per year ( D= C* 0.05) ( E) Clerical person hours per year ( E= C* 0.1) ( F) Annual costs ($ 1000/ yr)

1.0 Initial performance test N/ A 2.0 Repeat performance test 20 2 40 2 4 2.0 3.0 Litigation N/ A 4.0 Report review a) notification of const./

reconstr. N/ A b) notif. of anticipated startup N/ A c) notif. of actual startup N/ A d) notif. of modification N/ A e) notif. of compliance status N/ A f) notif. of performance test 4 2 8 0 1 0.4 g) notif. of process change N/ A h) notif. of inspection of storage vessel N/ A I) notif. of change in primary product N/ A j) precompliance report N/ A k) storage vessel initial compliance demonstration N/ A l) periodic reports of compliance status 4 80 320 16 32 16.1 TABLE 2b. ESTIMATE OF ANNUAL BURDEN AND COST TO THE FEDERAL GOVERNMENT TO IMPLEMENT REPORTING AND RECORDKEEPING REQUIREMENTS  SECOND AND THIRD YEARS 13 TOTAL BURDEN ( HRS)

AND COSTS 368 18 37 18.5 14 Individual tables for the first 2 years after the effective date were developed because the annual burden varied between the first and second year.

The third year burden is expected to be identical to the second year burden.

Labor rates and associated costs are based on estimated hourly rates of technical at $ 45, management at $ 67, and clerical at $ 21.

( d) Bottom Line Burden Hours and Costs/ Master Tables ( i) The simple collection: The annual bottom line respondent burden hours and costs are calculated by adding the total person hours and labor costs from Table 1a to the total person hours and labor costs from Table 1b multiplied by 2, and then dividing by the 3 year review period. The total annual burden hours and labor costs are:

Total burden,

hours Total costs,

$

Table 1a ( first year) 48,668 2,215,044 Table 1b x 2 ( second and third years) 48,088 2,109,572 Total 96,756 4,324,616 Bottom line annual burden 32,252 1,441,539 ( ii) The Agency tally: The annual bottom line Agency burden hours and costs are calculated by adding the total person hours and labor costs from Table 2a to the total person hours and labor costs from Table 2b multiplied by 2, and then dividing by the 3 year review period. The annual number of hours averaged over the first 3 years is 1,018 at a cost of $ 44,650 per year. 15 Total burden, hours Total costs, $

Table 2a ( first year) 2,208 96,864 Table 2b x 2 ( second and third years) 846 37,086 Total 3,054 133,950 Bottom line annual burden 1,018 44,650 ( iii) The complex collection: This section does not apply because this is a simple collection.

( iv) Variations in the annual bottom line: The annual burden hours and costs vary over the course of the 3 year review period because of the burden associated with initial reports and other one time activities ( e. g.,

developing the recordkeeping system). Also, more hours are allotted for training personnel in the first year over the second and third years. The respondent annual burden hours and costs for the first year are shown in Table 1a. In the second and third years, the burden hours and costs are lower because all existing facilities will have completed the first year activities.

Table 1b presents the total respondent burden hours for the second and third years following the effective date of the rule. These costs are representative of the on going recordkeeping and reporting burden resulting from the rule.

The Agency burden hours and costs will also vary over the 3 year review period because review of the notification of compliance status plan will occur only in the first year. Tables 2a and 2b present the Agency burden hours and costs of each of the 3 years following the effective date of the rule. The overall Agency burden after the first year of implementation will decrease to 423 hours. 16 ( e) Reasons for Change in Burden This section does not apply because this is a new collection.

( f) Burden Statement ( i) The EPA is required under section 112( d) of the Clean Air Act to regulate emissions of HAP's listed in section 112( b).

( ii) The information is needed as part of the overall compliance and enforcement program.

( iii) The total annual reporting and recordkeeping burden for this collection averaged over the first 3 years is estimated to be $ 1,441,539 per year for the entire source category. The average burden, per respondent, is 806 hours per year, and a one time capital cost of $ 2,000. The rule requires an initial one time notification from each respondent and subsequent notification every 6 months to indicate their compliance status. A respondent would also be required to keep necessary records of data to determine compliance with the standards in the regulation. The data would be recorded monthly. There would be an estimated 40 respondents initially applicable to the proposed collection requirements. This burden estimate 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.

Send comments on the Agency's need for this information, the accuracy of the 17 provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, to the Director,

OPPE Regulatory Information Division; U. S. Environmental Protection Agency ( 2136), 401 M St. S. W., Washington, DC 20460, and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th St. N. W., Washington, DC 20503, marked " Attention: Desk Officer for EPA."

Include the ICR number in any correspondence.

( iv) The respondents would be subject to applicable recordkeeping,

reporting, and other requirements in 40 CFR 63.9 and 63.10, as specified in the final rule.

( v) All information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in Title 40, Chapter 1, Part 2, Subpart B Confidentiality of Information ( see 40 CFR part 2; 41 FR 36902, September 1, 1076; amended by 43 FR 39999, September 8, 1978; 43 FR 42251, September 28, 1978; 44 FR 17674,

March 23, 1979).

( vi) An Agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in a table in 40 CFR part 9. The EPA will amend part 9 when the ICR is approved. 18 PART B OF THE SUPPORTING STATEMENT This section is not applicable because statistical methods are not used in the data collection associated with this regulation. ATTACHMENT 1 Source Data and Information Requirements REQUIREMENT CITATION NOTIFICATIONS Notification of construction or reconstruction 63.5; 63.1417 Notification of anticipated date of initial startup 63.5; 63.1417 Notification of actual date of initial startup 63.5; 63.1417 Notification of modification 63.5; 63.1417 Notification of intent to conduct a performance test 63.1417 RECORDKEEPING Start up, shutdown, and malfunction plan/ records 63.6; 63.1416 Documentation of control device performance 63.1416 design evaluation 63.1416 performance test 63.1416 Values measured by continuous monitoring systems 63.1416 Monitoring system calibrations, maintenance 63.1416 Periods of monitoring system failure/ shutdown 63.1416 REPORTING Precompliance report 63.1417 Notification of Compliance Status 63.1417 Periodic reports ( semiannual) 63.1417 statement of compliance ( if no exceedances occurred) 63.1417 daily, batch cycle, & block average monitoring data for any periods where exceedances or excursions occur 63.1417 periods of monitoring system downtime 63.1417 results of any performance tests 63.1417 start up, shutdown, malfunction reports 63.1417 Other reports 63.1417 notification of change in primary product 63.1417 notification of process change that impacts group status 63.1417 notification of change in designation of control device from small to large 63.1417 ATTACHMENT 2 Description of Respondent Activities Description of Respondent Activities ( 1) Read Rule and Instructions are the activities, less training, which involve comprehending the provisions in the standard and understanding how they apply to the respective points at a facility.

( 2) Plan Activities represents such burdens as design, redesign,

scheduling, and selecting methods of compliance.

( 3) Training represents the portion of activities from ( 1) Read Rule and Instruction for which an average facility would elect to provide classroom instruction. The standard does not require specific training itself.

( 4) Create, Test, and Research and Development are the activities involving testing, retesting, establishing parameter monitoring levels and determining emission point applicability.

( 5) Gather Information, Monitor, and Inspect are the activities involving physical inspections of equipment, collection of monitored data and other related activities. Calibration and maintenance activities associated with monitoring devices are also included under this heading. This estimate does not include the monitoring of equipment leak components. The cost for monitoring equipment leak components is included as part of the cost of the leak detection and repair program.

( 6) Process/ Compile and Review are the activities that involve analysis of the information collected for accuracy and compliance, and include generation of appropriate reports and records required as a result. ( 7) Complete Reports represents the activities normally associated with filling out forms. Because the standard requires no standardized forms, these activities relate to the preparing of formal reports and cover letters as appropriate.

( 8) Record/ Disclose are activities that are solely recordkeeping that occur once the appropriate report information has been extracted. These activities involve software translation, duplication, or archival processes normally associated with data management and storage common to this industry.

( 9) Store/ File are again activities that are solely recordkeeping that occur once the appropriate report information has been extracted. The activities involve the management life cycle of records, from the time they are filed and stored, to the time they are disposed. ATTACHMENT 3 Assumptions Used in Cost Estimates Assumptions Used in Burden Estimates ( a) There are 40 major ( or " affected") sources and all are assumed to come into compliance during the first year.

( b) There are expected to be no new, modified, or reconstructed sources during the first three years.

( c) The typical affected source has 4 reactor batch process vents, 3 non reactor batch process vents, and no affected storage vessels or heat exchange systems.

( d) There are 27 affected sources that will be required to comply with the equipment leaks LDAR program; 25 have less than 500 components and 2 have more than 500 components.

( e) Each affected source will purchase a desktop computer to be used for compiling monitored data and for preparing reports. This purchase will occur during the first year and is the only capital cost attributed to the recordkeeping and reporting requirements.

( f) Management hours are assumed to equal 5 percent of the total technical hours required and clerical hours are 10 percent of the technical hours.

( g) Initial performance testing was assumed to take 280 technical hours ( 1 test leader for two weeks and 5 test crew for one week). An additional 40 hours were assumed for the establishment of parameter monitoring levels. Five percent of the initial tests will be repeated during the second year and five percent during the third year.

( h) Four hours per week were estimated for gathering monitoring information and maintaining monitoring equipment.


[Federal Register Volume 87, Number 16 (Tuesday, January 25, 2022)]
[Notices]
[Pages 3811-3812]
[FR Doc No: 2022-01372]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0801]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Exports Notification and Recordkeeping Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with notifications and records required for human drug,
biological product, device, animal drug, food, cosmetic, and tobacco
product exports.

DATES: Submit either electronic or written comments on the collection
of information by March 28, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 28, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 28, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-N-0801 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Exports Notification and
Recordkeeping Requirements.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the

validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.

Exports Notification and Recordkeeping Requirements--21 CFR 1.101

OMB Control Number 0910-0482--Extension

    Sections 801 and 802 of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 381 and 21 U.S.C. 382) charge the Secretary of
Health and Human Services, through FDA, with the responsibility of
helping to ensure that exports of unapproved new drugs, biologics,
devices, animal drugs, food, cosmetics, and tobacco products that are
not to be sold in the United States meet the requirements of the
country to which the product is to be exported. The respondents to this
information collection are exporters who have notified FDA of their
intent to export unapproved products that may not be sold or offered
for sale in domestic commerce in the United States as allowed under
section 801(e) of the FD&C Act. In general, the notification identifies
the product being exported (e.g., name, description, and in some cases,
country of destination) and specifies where the notifications were
sent. These notifications are sent only for an initial export.
Subsequent exports of the same product to the same destination or to
certain countries identified in section 802(b) of the FD&C Act would
not result in a notification to FDA.
    Respondents to the information collection are exporters of products
that may not be sold in the United States and are regulated by FDA's
Center for Drug Evaluation and Research (CDER); Center for Biologics
Evaluation and Research (CBER); Center for Devices and Radiological
Health (CDRH); Center for Veterinary Medicine (CVM); Center for Food
Safety and Applied Nutrition (CFSAN); and Center for Tobacco Products.
Respondents to this collection of information maintain records
demonstrating their compliance with the requirements in 21 CFR 1.101.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
1.101(d) (CBER).................               5              92             460              15           6,900
1.101(d) (CDER).................               5             180             900              15          13,500
1.101(d) (CDRH).................             160               1             160              15           2,400
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          22,800
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
1.101(b), (c), and (e) (CBER,                320               3             960              22          21,120
 CDER, CDRH, CFSAN, and CVM)....
1.101(b) Office of International               1             189             189              22           4,158
 Programs only..................
1.101(b) (currently regulated                322               3             966              22          21,252
 Tobacco Products)..............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          46,530
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of Agency data, we are retaining the currently
approved burden estimates associated with the individual reporting and
recordkeeping elements.

    Dated: January 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01372 Filed 1-24-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Proposed Rules]
[Pages 12648-12651]
[FR Doc No: 2013-04217]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0159; Directorate Identifier 2012-SW-010-AD]
RIN 2120-AA64

Airworthiness Directives; Robinson Helicopter Company

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede an existing airworthiness directive
(AD) for Robinson Helicopter Company (Robinson) Model R22, R22 Alpha,
R22 Beta, R22 Mariner, R44, and R44 II helicopters with certain main
rotor blades (blade) installed. The existing AD currently requires
inspecting each blade at the skin-to-spar line for debonding,
corrosion, a separation, a gap, or a dent and replacing any damaged
blade with an airworthy blade. Since we issued that AD, a terminating
action for the inspection requirements of that AD has been developed.
The proposed actions are intended to detect debonding of the blade
skin, which could result in blade failure and subsequent loss of
control of the helicopter, and to correct the unsafe condition by
replacing the main rotor blades with new blades that do not require the
AD inspection.

DATES: We must receive comments on this proposed AD by April 26, 2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the economic
evaluation, any comments received and other information. The street
address for the Docket Operations Office (telephone<PHONE_NUMBER>) is in
the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.
    For service information identified in this proposed AD, contact
Robinson Helicopter Company, 2901 Airport Drive, Torrance, CA 90505;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at http://www.robinsonheli.com/servelib.htm. You may review a copy of service
information at the FAA, Office of the Regional Counsel, Southwest
Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas 76137.

FOR FURTHER INFORMATION CONTACT: Fred Guerin, Aviation Safety Engineer,
Los Angeles Aircraft Certification Office, Transport Airplane
Directorate, FAA, 3960 Paramount Blvd., Lakewood, CA 90712; telephone
(562) 627-5232; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    On June 2, 2011, we issued AD 2011-12-10, amendment 39-16717 (76 FR
35330, June 17, 2011) (AD 2011-12-10) for Robinson Model R22, R22A, R22
Beta, and R22 Mariner helicopters, with a blade, part number (P/N)
A016-4; and Model R44 and R44 II helicopters, with a blade, P/N C016-2
or C016-5. We

corrected a typographical error in AD 2011-12-10 on March 5, 2012 (77
FR 12991). AD 2011-12-10 requires a pilot check of the blade skin-to-
spar joint area for any bare metal before the first flight of each day.
That AD also requires, within 10 hours time-in-service (TIS), and
thereafter at 100-hour TIS intervals or at each annual inspection, or
if any bare metal is found during the pilot check, inspecting each
blade for corrosion, separation, a gap, or a dent by following certain
procedures in Robinson R22 Service Bulletin SB-103, dated April 30,
2010, for Model R22 series helicopters or Robinson R44 Service Bulletin
SB-72, dated April 30, 2010, for Model R44 series helicopters. That AD
also requires refinishing any bare metal before further flight and
replacing any damaged blade with an airworthy blade.
    AD 2011-12-10 superseded AD 2007-26-12, Amendment 39-15314 (73 FR
397, January 3, 2008) (AD 2007-26-12) which requires a one-time visual
inspection for skin separation along the leading edge of the blade skin
aft of the skin-to-spar bond line on the lower surface of each blade
and in the tip cap area. AD 2007-26-12 also requires a ``tap test'' for
detecting a separation or void in both bonded areas, repainting any
exposed area of the blades, and replacing any blade if separation or a
void occurs. That AD was prompted by 11 reports of blade debond, some
occurring in flight and some found during routine maintenance.

Actions Since Existing AD Was Issued

    Since we issued AD 2011-12-10, Robinson has developed replacement
blades on both the R22 and R44 helicopters, and we have determined that
replacing P/N A016-2 and -4 blades with P/N A016-6 blades for the Model
R22 helicopter and P/N C016-2 and -5 blades with P/N C016-7 blades for
the Model R44 helicopter will constitute terminating action for all
requirements of that AD. We have also determined that it is in the
interest of safety that all blades are replaced within 5 years. The
actions of this AD are intended to detect debonding or a void in the
blade, which could lead to failure of the blade and subsequent loss of
control of the helicopter. These actions will also correct the unsafe
condition by replacing the main rotor blades with new blades that do
not require the AD inspection.
    Also, since issuing AD 2011-12-10, we have received comments from
13 commenters and have given due consideration to each one. We have
identified seven unique issues and addressed those issues as follows:
    Three commenters stated that making a logbook entry each day
showing the AD check for paint is unnecessary and burdensome. The
commenters also stated it is the same importance as other pre-flight
checks that are not documented. One commenter suggested replacing the
daily check and logbook entry with a pre-flight check and no logbook
entry. One commenter stated that ``we need to trust the pilots and
maintenance people to do their jobs and not add to this burden of it
looks good on paper world.'' We do not agree. FAA policy requires a
logbook entry for checks performed pursuant to the directions of an AD.
    Four commenters stated it is not necessary to shorten the
retirement life of main rotor blades by AD. They stated the cost is
high compared to the safety benefit, it could put small operators out
of business, and the problem is caused by poor inspection practices.
One commenter added that routine inspections are performed before
flight and if any defects were discovered that operator would be aware
of it and not attempt flight until repairs were made. If operated in an
environment where none of the causal factors exist, reliance on
continued inspections is an adequate and appropriate long term solution
to blade replacement. We do not agree. AD 2011-12-10 does not decrease
the retirement life of the affected blades. While this proposed AD
supersedure would require blade life reduction and replacement, we are
providing for public comment prior to adoption of the proposed AD.
    Three commenters expressed concern that the cost estimates for
older R44 Astro model helicopters is inaccurate, as these models must
be refitted with hydraulic assisted controls before the new aluminum
blades can be operated. They further stated that this modification can
only be performed at the Robinson factory and the cost for shipping and
overhaul is high. They question who will pay for the loss of income and
state that mandating replacement of the -5 blade would have the
unintended consequence of immediately grounding and placing an entire
class of safe machines beyond economical repair. One of these
commenters stated that replacing the blades on his R44 has been
``financially devastating'' due to both replacement costs and his loss
of revenue, and believes Robinson should be responsible for these
costs, not owners.
    We do not agree. We are aware that the replacement blades for the
R44 Astro are not compatible with a helicopter without hydraulic
assisted controls, but we disagree that the R44 Astro will be beyond
economical repair as many R44 Astros have been refitted with
hydraulics, and conversions occur often. AD 2011-12-10 estimated costs
for replacing one blade if debonding was present, and did not address
any costs to modify the helicopter to accept the new part-numbered
blades manufactured by Robinson. The FAA does not concur with the
commenter's request that the FAA require the manufacturer to cover the
cost of replacing the blades. The FAA recognizes that the general
obligation of the operator to maintain aircraft in an airworthy
condition is vital, but sometimes expensive. The FAA considers that, in
the interest of maintaining safe aircraft, prudent operators would
accomplish the required actions even if they were not required to do so
by the AD. However, the manufacturer, not the FAA, determines if the
manufacturer will cover the cost of implementing a particular action.
Therefore, no change in this regard is necessary.
    One commenter requested the immediate adoption of an airworthiness
directive requiring replacement of the main rotor blades, and expressed
concern that the FAA was giving more consideration to any financial
impact on Robinson than to the risk to the flying public. We do not
agree that immediately requiring replacement of the blades is
necessary, as we have determined that proper inspection is adequate to
protect the safety of the fleet for the short term. This proposed AD to
terminate the inspections by mandating blade replacement after five
years is intended to allow time for blade manufacture, distribution,
and installation without causing undue hardship to operations, and to
protect the long term safety of the fleet.
    One commenter stated that the current method of detecting the
debonding issue is acceptable provided the inspection is performed
properly and repainted when necessary to prevent the bonding from being
exposed to the elements. This commenter disagreed that the problem is
not a manufacturing problem and expressed concern that the variance in
design of the blades is contributing to the situation. The commenter
questioned whether other manufacturers are having similar issues and
whether the new -7 replacement blades are produced under a different
manufacturing process to ensure the current problem will be eliminated.
The FAA disagrees that the cause of the debond is a failure of the
manufacturing process. The debonding is being caused by the basic blade
design, which allows erosion of the

bond line if left unprotected in an erosive environment. The
replacement blades were redesigned using best practices, engineering
integrity, and heightened oversight. While we believe the redesigned
blades will correct the unsafe condition, the FAA cannot guarantee any
design change will not, in the future, develop a problem that requires
correction.
    One commenter noted that a previous Civil Aviation Safety Authority
(CASA) AD required a detailed inspection to determine blade
airworthiness should any exposed blade skin aft of the skin-to-spar
bond line be found, and that AD 2011-12-10 only requires refinishing
the blade should the bond line be found to be exposed, without further
inspection. The FAA agrees. Due to a typographical error in the AD, the
requirement to skip further inspection prior to refinishing was caused
by an incorrect reference to the refinishing paragraph instead of the
inspection paragraph. A revision to AD 2011-12-10, Amendment 39-16717
(77 FR 12991, March 5, 2012) was issued on January 3, 2012, so that the
AD language now refers to the correct paragraph.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of these same type
designs.

Related Service Information

    We have reviewed the following Robinson service information:
     Letter titled ``Additional Information Regarding Main
Rotor Blade Skin Debonding,'' dated May 25, 2007, discussing blade skin
debonding;
     Rotorcraft Flight Manual (RFM) changes to the Normal
Procedures Section 4 and Systems Description Section 7, revised April
20, 2007, for each applicable model helicopter containing a ``caution''
about skin-to-spar bond line erosion;
     One Service Letter with two different Nos.: R22 SL-56B and
R44 SL-32B, both revised April 30, 2010, specifying proper inspection
and protection (refinishing) of bonded areas; and
     Service Bulletins SB-103 for the Model R22 and SB-72 for
the Model R44, both dated April 30, 2010, specifying proper inspection
and protection (refinishing) of bonded areas for certain affected
blades.
     R44 Service Letter SL-37, dated June 18, 2010, specifying
the required modifications for a carbureted R-44 to install P/N C016-7
blades.

Proposed AD Requirements

    This proposed AD would retain the pilot check, recurring
inspection, and blade refinishing requirements of AD 2011-12-10. The
pilot check may be performed by an owner/operator (pilot) holding at
least a private pilot certificate and must enter compliance into the
aircraft maintenance records in accordance with 14 CFR 43.11 and
91.417(a)(2)(v). This authorization is an exception to our standard
maintenance regulations.
    This proposed AD would add a requirement, within five years of the
effective date, to replace both main rotor blades with the new part-
numbered aluminum blades. Replacing the blades with the new part-
numbered blades would constitute terminating action of the recurring
inspection requirements.

Costs of Compliance

    We estimate that this proposed AD would affect 1,290 Model R22
helicopters and 1,353 Model R44 helicopters, for a total of 2,643
helicopters of U.S. Registry. We estimate that operators may incur the
following costs in order to comply with this AD:
     Time to perform the before flight check each day is
negligible.
     Inspecting both blades will require about three work hours
at an average labor rate of $85 per hour, for a total cost per
helicopter of $255 and a total cost to the U.S. operator fleet of
$673,965.
     Replacing both blades on a Model R22 helicopter will
require about 20 work hours at an average labor rate of $85 per hour
and required parts will cost $29,808, for a total cost per helicopter
of $31,508 and a total cost to the U.S. R22 operator fleet of
$40,645,320 over a 5-year period.
     Replacing both blades on a Model R44 helicopter with
hydraulically boosted flight controls installed (approximately 1053
helicopters) will require about 20 work hours at an average labor rate
of $85 per hour and required parts will cost $43,783, for a total cost
per helicopter of $45,483 and a total cost to the U.S. R44 operator
fleet of $47,893,599 over a 5-year period.
     Replacing both blades on a Model R44 helicopter without
hydraulically boosted flight controls installed (approximately 300
helicopters) will require modifying the aircraft with hydraulic flight
controls, which will cost a flat rate (parts and labor) of $40,000,
which includes the P/N C016-7 blades, and installing the required
airframe provisions will require about 13 work-hours, at an average
labor rate of $85 per hour, and required parts will cost $28,199, for a
total cost per helicopter of $112,247, and a cost to U.S. operators of
$33,674,100 over a 5-year period.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator,

the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Amendment 39-16717 (76 FR
35330, June 17, 2011), and adding the following new AD:

Robinson Helicopter Company: Docket No. FAA-2013-0159; Directorate
Identifier 2012-SW-010-AD.

(a) Applicability

    This AD applies to Model R22, R22 Alpha, R22 Beta, and R22
Mariner helicopters with main rotor blade (blade), part number (P/N)
A016-2 or A016-4; and Model R44 and R44 II helicopters with blade,
P/N C016-2 or C-016-5, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as blade skin debonding,
which could result in blade failure and subsequent loss of control
of the helicopter.

(c) Affected ADs

    This AD supersedes AD 2011-12-10, Amendment 39-16717 (76 FR
35330, June 17, 2011).

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    (1) Before the first flight of each day, visually check for any
exposed (bare metal) skin-to-spar joint area on the lower surface of
each blade. The actions required by this paragraph may be performed
by the owner/operator (pilot) holding at least a private pilot
certificate and must be entered into the aircraft records showing
compliance with this AD in accordance with 14 CFR 43.9(a)(1)-(4) and
14 CFR 91.417(a)(2)(v). The record must be maintained as required by
14 CFR 91.417, 121.380, or 135.439.
    (2) If there is any bare metal in the area of the skin-to-spar
bond line, before further flight, inspect the blade by following the
requirements of paragraph (e)(3) of this AD.
    (3) Within 10 hours time-in-service (TIS), and at intervals not
to exceed 100 hours TIS or at each annual inspection, whichever
occurs first, inspect each blade for corrosion, separation, a gap,
or a dent by following the Compliance Procedure, paragraphs 1
through 6 and 8, of Robinson R22 Service Bulletin SB-103, dated
April 30, 2010 (SB103), or Robinson Service Bulletin SB-72, dated
April 30, 2010 (SB72), as appropriate for your model helicopter.
Although the Robinson service information limits the magnification
to 10 x, a higher magnification is acceptable for this inspection.
Also, an appropriate tap test tool which provides similar
performance, weight, and consistency of tone may be substituted for
the ``1965 or later United States Quarter-dollar coin,'' which is
specified in the Compliance Procedure, paragraph 2, of SB72 and
SB103.
    (4) Before further flight, refinish any exposed area of a blade
by following the Compliance Procedure, paragraphs 2 through 6, of
Robinson R22 Service Letter SL-56B or R44 Service Letter SL-32B,
both dated April 30, 2010, as appropriate for your model helicopter.
    (5) Before further flight, replace any unairworthy blade with an
airworthy blade.
    (6) Within 5 years of the effective date of this AD:
    (i) For Model R22 series helicopters, replace blade P/N A016-2
or A016-4 with a blade, P/N A016-6.
    (ii) For Model R44 series helicopters fitted with hydraulically
boosted main rotor flight controls, replace blade P/N C016-2 or
C016-5 with a blade, P/N C016-7.
    (iii) For Model R44 series helicopters without hydraulically
boosted main rotor flight controls, replace blade P/N C016-2 or
C016-5 with a blade, P/N C016-7. Prior to installing a blade P/N
C016-7, verify the helicopter has been modified as required by
Robinson R44 Service Letter SL-37, dated June 18, 2010, Compliance
Procedures, paragraphs 1. through 10.
    (iv) Installing blades, P/N A016-6 or P/N C016-7, is terminating
action for the inspection requirements of paragraphs (e)(1) through
(e)(4) of this AD.

(f) Special Flight Permit

    Special flight permits will not be issued.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office, FAA,
may approve AMOCs for this AD. Send your proposal to: Fred Guerin,
Aviation Safety Engineer, Los Angeles Aircraft Certification Office,
Transport Airplane Directorate, FAA, 3960 Paramount Blvd., Lakewood,
CA 90712; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(h) Additional Information

    The Robinson letter titled ``Additional Information Regarding
Main Rotor Blade Skin Debonding,'' dated May 25, 2007, which is not
incorporated by reference, contains additional information about the
subject of this AD. For service information identified in this AD,
contact Robinson Helicopter Company, 2901 Airport Drive, Torrance,
CA 90505; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at http://www.robinsonheli.com/servelib.htm. You may review a copy of this
information at the FAA, Office of the Regional Counsel, Southwest
Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas 76137.

(i) Subject.

    Joint Aircraft Service Component (JASC) Code: 6210: Main Rotor
Blades.

    Issued in Fort Worth, Texas, on February 12, 2013.
Bruce Cain,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2013-04217 Filed 2-22-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 90 (Wednesday, May 10, 2023)]
[Notices]
[Pages 30133-30135]
[FR Doc No: 2023-09891]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-E-0675]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Detectnet

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for Detectnet and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic
or written comments and ask for a redetermination by July 10, 2023.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by November 6, 2023. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,

untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 10, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-E-0675 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; Detectnet.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product Detectnet
(copper Cu-64 dotatate). Detectnet is a radioactive diagnostic agent
indicated for use with positron emission tomography for localization of
somatostatin receptor positive neuroendocrine tumors in adult patients.
Subsequent to this approval, the USPTO received a patent term
restoration application for Detectnet (U.S. Patent No. 10,383,961) from
Somscan APS, and the USPTO requested FDA's assistance in determining
the patent's eligibility for patent term restoration. In a letter dated
June 13, 2022, FDA advised the USPTO that this human drug product had
undergone a regulatory review period and that the approval of Detectnet
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
Detectnet is 989 days. Of this time, 744 days occurred during the
testing phase of the regulatory review period, while 245 days occurred
during the approval phase. These periods of time were derived from the
following dates:

    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
December 21, 2017. The applicant claims November 28, 2017, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was December
21, 2017, which was the first date after receipt of the IND that the
investigational studies were allowed to proceed.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: January 3,
2020. FDA has verified the applicant's claim that the new drug
application (NDA) for Detectnet (NDA 213227) was initially submitted on
January 3, 2020.
    3. The date the application was approved: September 3, 2020. FDA
has verified the applicant's claim that NDA 213227 was approved on
September 3, 2020.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 312 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: May 4, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09891 Filed 5-9-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 186 (Wednesday, September 27, 2023)]
[Notices]
[Pages 66457-66458]
[FR Doc No: 2023-20738]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2343]

Hazard Analysis and Risk-Based Preventive Controls for Human
Food; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of two additional draft chapters of a
multichapter draft guidance for industry entitled ``Hazard Analysis and
Risk-Based Preventive Controls for Human Food.'' This multichapter
draft guidance, when finalized, will explain FDA's current thinking on
how to comply with the requirements for hazard analysis and risk-based
preventive controls under FDA's regulation entitled ``Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Human Food.'' The newly available draft chapters are
entitled ``Chapter 11--Food Allergen Program'' and ``Chapter 16--
Acidified Foods.'' This draft guidance is not final nor is it in effect
at this time.

DATES: Submit either electronic or written comments on the draft
guidance by March 25, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-2343 for ``Hazard Analysis and Risk-Based Preventive
Controls for Human Food.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Office of Food Safety (HFS-300), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740. Send two self-addressed adhesive labels to assist that office
in processing your requests. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Linda Kahl, Center for Food Safety and
Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of two draft chapters entitled
``Chapter 11--Food Allergen Program'' and ``Chapter 16--Acidified
Foods'' of a multichapter draft guidance for industry entitled ``Hazard
Analysis and Risk-Based Preventive Controls for Human Food.'' We
previously announced the availability of several chapters of that draft
guidance as shown in table 1.

   Table 1--Available Draft Chapters in Hazard Analysis and Risk-Based
                   Preventive Controls for Human Food
------------------------------------------------------------------------
      Chapter No.              Chapter title             Publication
------------------------------------------------------------------------
N/A....................  Introduction.............  81 FR 57816, August
                                                     24, 2016.
1......................  The Food Safety Plan.....  81 FR 57816, August
                                                     24, 2016.
2......................  Conducting a Hazard        81 FR 57816, August
                          Analysis.                  24, 2016.
3......................  Potential Hazards          81 FR 57816, August
                          Associated with the        24, 2016.
                          Manufacturing,
                          Processing, Packing, and
                          Holding of Human Food.
4......................  Preventive Controls......  81 FR 57816, August
                                                     24, 2016.
5......................  Application of Preventive  81 FR 57816, August
                          Controls and Preventive    24, 2016.
                          Control Management
                          Components.
6......................  Use of Heat Treatments as  82 FR 41364, August
                          a Process Control.         31, 2017.
14.....................  Recall plan..............  84 FR 53347, October
                                                     7, 2019.
15.....................  Supply-Chain Program for   83 FR 3449, January
                          Human Food Products.       25, 2018.
Appendix 1.............  Potential Hazards for      81 FR 57816, August
                          Foods and Processes.       24, 2016.
Appendix 2.............  Food Safety Plan Forms...  81 FR 57816, August
                                                     24, 2016.
Appendix 3.............  Bacterial Pathogen Growth  81 FR 57816, August
                          and Inactivation.          24, 2016.
------------------------------------------------------------------------

    We also are announcing changes to the expected table of contents
for the complete multichapter guidance.
    We are issuing these chapters of the draft guidance consistent with
our good guidance practices regulation (21 CFR 10.115). The draft
guidance, when finalized, will represent the current thinking of FDA on
how to comply with the requirements for hazard analysis and risk-based
preventive controls under part 117 (21 CFR part 117), principally in
subparts C and G. It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.
    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
enables FDA to better protect public health by helping to ensure the
safety and security of the food supply. FSMA enables FDA to focus more
on preventing food safety problems rather than relying primarily on
reacting to problems after they occur. FSMA recognizes the important
role industry plays in ensuring the safety of the food supply,
including the adoption of modern systems of preventive controls in food
production.
    Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic
Act (FD&C Act) by adding section 418 (21 U.S.C. 350g) with requirements
for hazard analysis and risk-based preventive controls for
establishments that are required to register as food facilities under
our regulations in 21 CFR part 1, subpart H, in accordance with section
415 of the FD&C Act (21 U.S.C. 350d). We have established regulations
to implement these requirements within part 117.
    We intend to announce the availability for public comment of
additional chapters of the draft guidance as we complete them. The
titles of the additional chapters that we expect to make available for
public comment are included in the table of contents for the complete
multichapter guidance.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in part 117 have been approved under OMB control number 0910-0751.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/FoodGuidances, https://www.fda.govregulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.

    Dated: September 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20738 Filed 9-26-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: March 16, 2009 (Volume 74, Number 49)]
[Notices]
[Page 11119-11120]
[DOCID:fr16mr09-68]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Industry Exchange Workshop on Food and Drug Administration Drug
and Device Requirements; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA) Chicago District, in
cosponsorship with the Association of Food and Drug Officials (AFDO),
is announcing a public workshop entitled ``Drugs and Devices--Promoting
and Protecting the Public Health Through Risk Management and Product
Cycle Improvement.'' This 2-day public workshop is intended to provide
information about FDA drug and device regulation to the regulated
industry.
    Date and Time: The public workshop will be held on Monday, June 8,
2009, from 10:20 a.m. to 5 p.m. and Tuesday, June 9, 2009, from 8 a.m.
to 5 p.m.
    Location: The public workshop will be held at the Doubletree Hotel
Chicago--Oakbrook, 1909 Spring Rd., Oak Brook, IL 60523, 800-222-TREE,
800-222-8733, or<PHONE_NUMBER>, FAX:<PHONE_NUMBER>.
    Attendees are responsible for their own accommodations. To make
reservations at the Doubletree Hotel Chicago--OakBrook, at the reduced
conference rate, contact the Doubletree Hotel Chicago--OakBrook before
May 5, 2009, citing meeting code ``AFDO Conference''.
    Contact: William Weissinger, Food and Drug Administration, 550 W.
Jackson Blvd., 15th Fl., Chicago, IL 60661,<PHONE_NUMBER>, FAX: 312-596-
4242, e-mail<EMAIL_ADDRESS>    Registration: You are encouraged to register by May 12, 2009. The
AFDO registration fees cover the cost of facilities, materials, and
breaks. Seats are limited; please submit your registration as soon as
possible. Course space will be filled in order of receipt of
registration. Those accepted into the course will receive confirmation.
Registration will close after the course is filled. Registration at the
site is not guaranteed but may be possible on a space available basis
on the day of the public workshop beginning at 7:30 a.m. The cost of
registration follows:

                          Cost of Registration
------------------------------------------------------------------------
                        Affiliation                               Fee
------------------------------------------------------------------------
Government (AFDO/North Central AFDO Member)                      $395.00
------------------------------------------------------------------------
Government (Non-Member)                                          $495.00
------------------------------------------------------------------------
Non-Government (AFDO/NCAFDO Member)                              $450.00
------------------------------------------------------------------------
Non-Government (Non-Member)                                      $550.00
------------------------------------------------------------------------
To be added to registration fee for workshop registration         $75.00
 postmarked after May 12,2009
------------------------------------------------------------------------

    If you need special accommodations due to a disability, please
contact William Weissinger at least 7 days in advance of the workshop.
    Registration instructions: To register, please submit your name,
affiliation, mailing address, phone, fax number, and e-mail, along with
a check or money order payable to ``AFDO.'' Please mail your payment
to: AFDO, 2550 Kingston Rd., suite 311, York, PA 17402. To register via
the Internet, go to www.afdo.org. (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).
    The registrar will also accept payment by major credit cards (VISA/
MasterCard only). For more information on the meeting, or for questions
on registration, contact AFDO,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, or e-
mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The public workshop helps fulfill the
Department of Health and Human Services' and FDA's important mission to
protect the public health. The workshop 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 the following:

     Risk management approach to consumer protection and
industry regulation
     How quality management systems (including corrective and
preventive action) contribute to product cycle improvement
     Supplier management and component controls for drugs and
devices
     Adverse drug event reporting requirements
     Medical device reporting requirements
     Recalls, corrections and removals
     Complaint handling from the FDA investigator's
perspective.
    FDA has made education of the drug and device manufacturing
community a high priority to help ensure the quality of FDA-regulated
drugs and devices. The workshop 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 to
stakeholders and the public. The workshop also is consistent with the
Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law
104-121), as outreach activities by Government agencies to small
businesses.

    Dated: March 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-5648 Filed 3-13-09; 8:45 am]

BILLING CODE 4160-01-S