of 3 µg/100 cm2 for non-production times.   This level was derived from
DOE’s housekeeping provision in the CBDPP rule (see Section 850.30).
The purpose of having this level would be to provide a quantitative
(rather than qualitative) limit to prevent the accumulation of beryllium
contamination on surfaces throughout the workplace.  Such accumulations,
if not controlled, pose a risk to skin (and perhaps beryllium
sensitization) and the re-suspension of beryllium particles into the
air.

The Agency has collected only a little information on beryllium surface
contamination.  Surface exposure is a major part of DOE’s CBDPPP
regulation where contamination and decommissioning of shops and
equipment are important issues.  There are two reasons for limiting
surface contamination:  one is to check the effectiveness of engineering
controls and housekeeping practices; the other to reduce skin exposures.
 Limiting surface contamination could potentially raise costs
significantly; however, as explained above in the costs for housekeeping
provisions, the Agency has provided considerable estimated additional
costs to the draft standard to cover additional clean up—15 minutes
per day for each affected production employee.  At this time the Agency
does not have enough information about the extent of surface
contamination levels or exposure to beryllium in affected industries to
provide a further estimate for this cost.  The cost of surface sampling
alone (without a requirement as a PEL) is addressed below.  The Agency
is not estimating the costs of maintaining a surface sampling PEL beyond
the costs already estimated under housekeeping provisions.

No Action Level

The written control program, medical surveillance, and exposure
monitoring are triggered by an action level (one-half the PEL).  An
option of no action level would trigger these provisions on the PEL
instead.  Generally, in its cost analysis, OSHA has assigned costs to
most of these provisions whether or not airborne exposures were above an
action level because of potential skin or eye exposure--which also
triggers these provisions.  The cost-savings of no action level are
estimated to range from about $0.2 million annually to about $1 million
(Table 17).  The disadvantage is that requiring provisions to be
triggered by the PEL might be less protective, especially if there is
remaining significant risk at the final PEL selected for the standard.

Exposure Monitoring

The preliminary draft standard contains provisions that require
employers to repeat personal monitoring at least every six months where
exposures are above the action level and every three months where
exposures are above the PEL.  Periodic monitoring can be stopped when
the monitoring indicates that the exposure is below the action level and
a second sample has confirmed that finding.

	The Agency is considering two options.  The first is to require
monitoring less frequently, shifting to every 6 months if above the PEL
and every year if above the action level. This option would relieve
employers of approximately one-half of the monitoring costs.  The cost
savings of less frequent monitoring are shown in Table 17 and range from
no additional cost at the current PEL level to $0.4 million across the
PEL alternatives.

However OSHA recently pointed out in its final rule, Standards
Improvement Project - Phase II (70 FR 1111, 1118 (Jan. 5, 2005)) that
"OSHA concludes, after reviewing the comments, that uniformity of
monitoring frequency [across occupational health standards] is
beneficial for employers and employees (unless there are specific
reasons for different frequency) because uniformity permits an employer
to develop a more efficient and thus better, industrial hygiene
program...."  In that rulemaking, OSHA standardized for most regulated
substances the 3 month/6 month frequency.  The advantages of uniformity
of monitoring frequency for small businesses needs to be considered.

The second option is to require periodic surface sampling. Surface wipe
samples would help employers determine the type of PPE and engineering
controls needed to effectively reduce or minimize exposures to
beryllium.  It can also permit evaluation of current housekeeping
efforts.  The disadvantage to this option is that, depending on the
frequency of the surface sampling, it would be costly for the employer,
especially small businesses, to collect samples, order necessary
equipment, and ship samples to a laboratory for analysis.   The Agency
has estimated the annual costs of this alternative as taking one sample
per year for every employee, including production employees in high
exposure industries and affected employees in the remaining industries.
Lab analysis of surface samples is expected to cost about $45 and the
Agency estimates that the time to take the sample, notify employees, and
perform recordkeeping is about 15 minutes.  Total unit costs of the
samples are about $55 and total annual costs are estimated at $605,000.

        The Agency is also interested in, but has not estimated
the costs of, a performance standard for exposure monitoring.  A
performance standard would place the burden on employers to determine
the appropriate number of air (or surface) samples to take, presumably
sufficient to meet some criterion for reliability that would be set by
the Agency.  In general, a performance based approach, in contrast to
simpler specification one, could be a much more complex and potentially
more burdensome, especially for small employers, although it might
reduce monitoring for some larger employers with an extensive database
of measurements and professional industrial hygiene staff.  The Agency
is requesting comment on what such an approach might look like and how
it could be effectively enforced.

Regulated Areas

The primary cost of regulated areas is providing respiratory protection
to non-production employees who enter.  The cost of setting up a
regulated area is modest.  One option the Agency is considering is to
expand the definition of regulated area to include the potential for
skin contact with beryllium.  This would essentially make production
areas into regulated areas due to the potential for skin exposure and
concerns about surface contamination.  This would reduce to some extent
the number of employees or others coming into contact with beryllium and
could also reduce cross contamination.  Under this definition, since
employees would actually already be under the airborne PEL, in most
cases, it would not affect employee respirator use, but it could affect
employees from other work areas who wish to enter the space.   If they
would have to don a respirator, this would increase those costs.
However, since exposures would not be above an airborne PEL, it is not
clear that for most of these regulated areas other employees would have
to wear a respirator to enter.  Perhaps a greater cost and impact on
exposure would be to further isolate production areas from other
employees.  The Agency is not providing an estimate of costs for this
option.  Clearly, the costs would be more than the simple PEL trigger,
but they may not be much greater if those entering do not have to don a
respirator.  The Agency has already concluded that most employees in
beryllium production areas are now wearing respirators, protective
clothing, and using change rooms and showers.  So these costs for those
employers would not be increased by expanding the scope or definition of
the regulated areas.

Methods of Compliance

The Agency is considering as an option to drop the requirement for
engineering controls to meet a PEL if beryllium is used fewer than 30
days per year.  Instead, employers could use respirators to protect
employees from exposure above a PEL. Engineering controls are part of
OSHA’s policy of following the hierarchy of controls to protect
employees from occupational hazards.  Removing the cause, or source, of
exposure with engineering and work practice controls is superior to
creating exposures/risk and then depending on PPE for safety.
Respiratory protection is dependent on the respirator and employee
behavior to succeed.  There is particular concern here because there is
evidence in the literature which suggests that exposure of less than 30
days can lead to beryllium sensitization.  This option would not affect
many of the industries in this analysis, but it could impact some
machine shops and abrasive blasting operations.  Machine shops currently
have fairly low exposure levels, and for many of these,
beryllium-related work is a small part of their business volume (see
attached reports on the Precision Turned Products industries).  Abrasive
blasters could be more greatly affected.  The Agency at this time does
not have any data that would provide an estimate of the frequency or
occasional use of coal and copper slags by blasters to meet the
fewer-than-30-day criterion.  The Agency has estimated that it would
cost about $36 million annually to substitute away from these
beryllium-containing slags.  If as much as one-quarter of the blasting
operations that would require a substitute (as currently under the draft
standard) would be allowed a 30-day limit, this would result in cost
savings of about $9 million annually.

Respiratory Protection

The preliminary draft standard directs employers to follow OSHA’s
Respiratory Protection Standard (29 CFR 1910.134). The Respiratory
Protection Standard includes provisions for written procedures for the
proper selection, use, cleaning, storage, and maintenance of
respirators.   OSHA is considering an alternative to require employers
to provide a higher level of respiratory protection (such as powered air
purifying respirators (PAPRs)) for its workers when performing
activities that generate sub-micron particles of beryllium.  PAPRs with
an assigned protection factor (APF) of 1,000 would be expected to
protect the worker more effectively against high levels of airborne
exposure to beryllium than other types of respirators such as air
purifying half mask (APF of  ten) or full facepiece (APF of fifty).
Requiring PAPRs could be more costly for the employer, especially small
businesses, not only to order them, but to maintain them, clean them,
and store them. The Agency’s cost model has many employees wearing
PAPRs now—one PAPR is made available for every 10 negative pressure
respirators.  The annual cost for wearing a PAPR is about $1,500
compared to about $500 for a negative-pressure respirator.  Annual costs
of providing PAPRs for every 1 in 5 employees are about $1.5 million and
for every employee about $13.4 million.

Personal Protective Clothing and Equipment

The Agency is considering two options in this area.  First, whether or
not to specify the type of clothing, gloves, etc. for certain jobs.
Secondly, to specify procedures for putting on and taking off PPE where
there is concern about ultrafine particles.  The Agency has
preliminarily concluded that neither of these provisions would pose a
significant addition to its current estimates of the costs of
compliance.  Specifications for clothing and equipment could potentially
raise employer costs by constraining employer flexibility or restricting
the choice as new products are developed.  The advantage to this option
would be that small business employers who would not normally employ
industrial hygiene expertise would know what PPE would be necessary for
a given operation without the expense of hiring an expert.  In regard to
methods of donning and doffing PPE, the Agency has already provided
considerable time for training and believes that such requirements could
be easily accommodated in the time given to that provision.

Hygiene Facilities

The preliminary draft standard requires that employers provide clean
change areas and hand washing and showering facilities when employee
exposures to  beryllium exceed the PEL or where there is anticipated
skin exposure from routine handling of beryllium powders and dusts or
contact with contaminated surfaces.  This provision is similar to other
OSHA standards and is designed to prevent spreading beryllium to other
non-exposed areas of the work site, and to employees’ homes, and to
provide facilities for removing any beryllium that may be on the
employee’s skin.

	The Agency is considering an option to drop the requirement for
employees to shower as part of the hygiene facility provisions.
Instead, only hand washing facilities would be required for removing
beryllium from employees’ skin.  Removing this provision would reduce
costs by about $12 million annually across all PEL levels as the
Agency’s cost model and assumptions had put most production employees
in protective clothing and provided change rooms and showers as well.
However, there are reported incidents of families members being
sensitized to beryllium and skin exposure may be a substantial source of
sensitization (Newman 1992).

Housekeeping

The preliminary draft standard requires that employers ensure that all
surfaces are free of accumulated beryllium, and they are cleaned by a
method that minimizes the likelihood of redistributing beryllium, such
as by the use of a HEPA-filter vacuum.   In addition, shoveling,
sweeping, and brushing may be used only where HEPA-filter vacuuming or
other methods that minimize the likelihood of beryllium exposure have
been tried and found not to be effective.  Employers are required to
eliminate the use of compressed air without ventilation to remove
beryllium from surfaces.

OSHA is considering one alternative in which OSHA would specify cleaning
procedures for removing, replacing, and cleaning air filters
contaminated with beryllium.  Employers would have specific procedures
to follow and would not have to consult outside expertise to know what
to do. The Agency does not believe that this would be a significant cost
item given that it has made substantial estimates of the time for
training under the standard.

Medical Surveillance

The Agency is considering an option to require a chest x-ray in the
initial medical exam to be evaluated by a B reader, and, as a second
option, to require x-rays every five years.  In the first option, as
part of the medical evaluation, the posteroanterior chest radiographs
are scored independently by a B reader.  The chest x-ray, along with
spirometry, may be used to establish a baseline for possible comparison
with future testing or evaluations.  This provision is consistent with
DOE’s provision on periodic x-rays (see 10 CFR 850.34).   The Agency
estimates that requiring an x-ray and B-reader in the initial exam would
add about $111,000 to costs when annualized over five years.  Requiring
an x-ray every five years would add about $215,000 annually to costs.
These costs would be constant across the PEL alternatives.

	The Agency is also considering an option to require that previously
exposed employees be included in medical surveillance—with a medical
exam every three years.  The Agency does not believe that this would be
a significant additional cost for most affected industries.  The Agency
believes that internal turnover out of production work (but staying with
the employer) is not high in most of the affected industries in the
analysis.  The unit costs of providing surveillance have been presented
(above) in this analysis ($377); providing medical surveillance every
three years for previously exposed employees would roughly cut that
annual cost by one-third (on an annual basis) for previously exposed
employees.  But the Agency has no data with which to estimate how many
employees would be affected.

	The preliminary draft standard requires that all medical examinations
be performed by or under the supervision of a physician or licensed
health care professional (PLHCP).  However, in the case of beryllium,
there are certain medical complexities in diagnosing, treating, and
providing effective medical follow-up of beryllium-exposed employees,
particularly those who have had an abnormal (i.e. positive) response on
the BeLPT.   In order to address these medical complexities, OSHA is
considering three alternatives to the PLHCP.  The first alternative is
to require that all medical examinations be performed by or under the
supervision of a physician only.  OSHA is also considering a second
alternative to address the added concern that not all physicians may
have experience in this area due to the fact that cases of CBD are not
as common as other medical conditions.   Under this alternative, all
medical examinations would be required to be performed by or under the
supervision of a physician with knowledge and expertise in the diagnosis
and treatment of CBD.  However, since many of the medical complexities
may arise in the management of employees who have been determined to
have an abnormal or positive BeLPT test (i.e. they are sensitized to
beryllium), OSHA is also considering a third alternative.  This
alternative would require that if an employee is determined to be
sensitized to beryllium, then all medical examinations would be required
to be performed by a physician with knowledge and expertise in the
diagnosis and treatment of CBD.  This would limit the occasions when
beryllium-specific expertise would be required and would help to assist
the employer in deciding when special medical expertise would be
necessary.  The Agency has not estimated the costs of these
alternatives.

Training

The Agency is considering a requirement to provide additional training,
or retraining, every three years.  The Agency has estimated the annual
cost of such an optional provision as roughly one-third of the cost of
initial training, or about $1.9 million to $3.7 million annually,
depending on the PEL (Table 17).  The Agency’s view of training is
that it is one of the most effective ways to educate employees about
occupational risks and provide protection from these hazards, and that
it re-inforces employers’ policies and commitment.

Adopt the DOE Regulation

One major alternative to the preliminary draft standard would be to
adopt, in its entirety, the DOE Chronic Beryllium Disease Prevention
Program regulation--to the extent that the OSH Act would allow.  DOE
currently has provisions to prevent CBD from occupational exposures to
beryllium for DOE employees and its contractors at all DOE facilities
[see DOE’s (CBDPP) final rule, 10 CFR Part 850, December 8, 1999, Part
III, pp. 68854-68914].  In its regulation DOE specifically delegated to
OSHA responsibility for setting an airborne permissible exposure limit
(10 CFR 850.22).    The DOE Chronic Beryllium Disease Prevention Program
has an action level of 0.2 g/m3, and it and the preliminary draft
standard share most of the same provisions.  The DOE regulation has more
requirements for surface sampling than OSHA’s preliminary draft
standard.  The Agency believes that the costs estimated in this analysis
for a PEL of 0.2 g/m3 would reasonably approximate the costs of
adopting the essentials of the DOE standard as an OSHA health standard.

PEL Only Standard

This regulatory option would eliminate all costs except for engineering
controls (and respiratory protection where still necessary) and
protective clothing, assuming that the PEL would have a designation for
skin protection, for which employers would provide protective clothing,
gloves, equipment, etc.  The cost savings for this alternative range
from $30 million to $50.8 million annually, which basically reflect
dropping remaining program or ancillary provision costs.   However, the
Agency has preliminarily determined that the risk of beryllium,
especially, argues for the necessity of a comprehensive program.  There
is evidence that employees may become sensitized via the skin.  This
argues strongly not only for stringent housekeeping but also protective
clothing, changing rooms, and showers.  The current theory of disease is
that it a two-step process, with CBD following beryllium sensitization.
Medical surveillance is therefore needed to protect employees, to alert
employers of weakness in exposure control efforts, and to continue to
collect information about this not-fully-understood disease process.
Provisions for exposure assessment are critical for planning engineering
controls.  In addition, Section 6(b)(7) of the OSH Act requires a 6(b)
standard to include provisions for labeling and warning signs, exposure
monitoring, and medical surveillance.  Such provisions seem especially
appropriate for a beryllium standard.

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桤ā㄀$ᔀconsidering whether to remove an employee from the area(s)
with beryllium exposure, the MRP provisions normally would specify that
the employee may select a second PLHCP for a second opinion, after first
visiting a PLHCP designated by the employer.  The second PLHCP normally
would review any previous findings, determinations or recommendations of
the initial PLHCP and conduct any appropriate medical examinations,
consultations, and laboratory tests deemed necessary.

	If an employee tested positive for beryllium sensitization or was
diagnosed with CBD, the MRP option would require employers to provide a
PAPR or to offer an available job with exposures below the action level.
 The employer would have to maintain the employee’s original earnings
and other benefits. This option would also provide for additional
physician’s review and evaluation of the employee’s health status if
necessary.  Table 18 presents a model for estimating the costs of MRP.

	OSHA estimated the number of employees subject to MRP as the total
number of employees in the exposure profile less the number of employees
in abrasive blasting and

Table 18dental technicians.  The Agency then estimated the number of
employees with median exposures above 0.1 g/m3 and who did not work
for an employer who already has a

removal program, which left 7,000 employees.  To estimate the number who
might be subject to MRP, the Agency multiplied that total by 3.7
percent, which was the prevalence rate that DOE found across a large
number of its employees and contractors’ employees (this also roughly
corresponded to prevalence rates from other cohorts).  An estimated 264
employees are expected to be sensitized to beryllium or have CBD in the
first year, and there will be 26 new employees each year who are
expected to qualify for

the benefit. (Note:  In the benefits analysis above, the Agency
estimated 59-144 new cases of BeS and CBD at a PEL of 0.1 (Table 7); but
for purposes of estimating costs for MRP the Agency simplified the
counting of cases and also subtracted employers with existing removal
programs.)  Assuming employers comply with the medical removal
protection requirements by assigning employees with beryllium-related
health conditions to alternative jobs, the cost of MRP would depend on
the difference between the employee’s customary wage and the wage that
would normally be paid for the alternative work.  OSHA estimated costs
for medical removal protection by using the difference between the
average annual wages, including benefits, for production employees in
manufacturing and the average wages for a basic clerical job, or file
clerk. The Agency used a similar method of estimating the cost of MRP in
its Crystalline Silica PIRFA. This differential amounted to about $4,600
for a year, the total length of the MRP protection.   The Agency
estimates that one-half of employees entitled to MRP will be placed in
an alternative available job.  The remaining 50 percent would be divided
between individuals who would receive employees’ compensation for
beryllium-related disability and employees who would work in PAPRs since
(the model assumes) there would not be an available alternative job with
exposures below the action level.  The annual cost of a PAPR is
estimated at $1,416 and the cost of employees’ compensation two-thirds
of normal gross wages.  The first year costs of MRP are then estimated
to be about $1.5 million and  about $150,000 for new cases in future
years (Table 18).  Annualizing the first year costs over 10 years with a
7 percent discount rate yields about $225,000 (annually).   Total annual
costs are then estimated at about $375,000 for the MRP option.

This cost impact may not be borne evenly by all firms.  Only a small
number of firms will be affected in a given year, but for those firms
the impact could be considerable—about $5,000 per case.  In addition,
this analysis assumes that businesses will often be able to find an
alternate job for the employee on medical removal, albeit at a reduced
level of productivity.  While this provides a useful means of estimating
the average case, this may not always be the case for individual firms,
particularly for small firms. While some firms might be able to offset
such a cost by placing the employee

on employees compensation, for those firms that are not able to, or are
largely experience rated, the cost per case could be greater than the
average.

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Newman, L. S., Kreiss, K. Nonoccupational beryllium disease masquerading
as sarcoidosis: identification by blood lymphocyte proliferative
response to beryllium. Am Rev Respir Dis, 1992 May;145(5):1212-4

Peyton MF, Worchester J., [Worchester, 1959], “Exposure Data and
Epidemiology of the Beryllium Case Registry 1958”, AMA Arch Ind
Health, 1959; 19:94-99.

Rosenman, K., Hertzberg, V., Rice, C., Reilly, M. J., Aronchick, J.,
Parker, J. E., Regovich, J., Rossman, M., Chronic beryllium disease and
sensitization at a beryllium processing facility.

Environ Health Perspectives, Volume 113(10):1366-72 (2005).

Sanderson, W.T., Petersen. M.R., and Ward, E.M., Estimating Historical
Exposures of Workers in a Beryllium Manufacturing Plant, American
Journal of Industrial Medicine, 36:145-157, (2001).

Sanderson W.T.,  Ward, E.M., Steenland, K., and Peterson, M.R., Lung
Cancer Case-Control Study of Beryllium Workers, American Journal of
Industrial Medicine, 36:133-144, (2001).

Schuler, C.R., Kent, M.S., Deubner, D.C., Berakis, M.T., McCawley, M.,
Henneberger, P.K., Rossman, M.D., and Kreiss, K., Process-Related Risk
of Beryllium Sensitization and Disease in a Copper-Beryllium Alloy
Facility, American Journal of Industrial Medicine, 47:195-205, (2005).

Stange, A., Furman, F. J., Hilmas, D. E., The Beryllium Lymphocyte
Proliferation Test: Relevant Issues in Beryllium Health Surveillance,
American Journal of Industrial Medicine, 46:453-462, (2004).

 Steenland K. and Ward, E., “Lung Cancer Incidence Among Patients With
Beryllium Disease:  A Cohort Mortality Study,” Journal of the National
Cancer Institute, 83 (1991), 1380-1385.

Tinkle, S.S.,  Anthonini, J. M., Rich, B. A., Roberts, J. R., Salmen,
R., DePree, K., and Adkins, E. J., Skin as a Route of Exposure and
Sensitization in Chronic Beryllium Disease, Environmental Health
Perspectives, Volume 111(9): July 2003.

Yoshida, T. Shima, S., Nagaoka, K., Taniwaki, H., Wada, A., Kurita, H.,
and Morita, K., A Study on the Beryllium Lymphocyte Transformation Test
and the Beryllium Levels in Working Environment, Industrial Health,
35:374-379, 1997.

 Note that estimates of cumulative, mean, and peak exposures in
Henneberger et al. were constructed based on individual work histories
and job-specific exposure sampling, not personal sampling of each
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Date circulated:    June 14, 2007


1 SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY NSPS for VOC Emissions From Petroleum Refinery Wastewater Systems ( 40 CFR part 60, subpart QQQ) ( Renewal)

1. Identification of the Information Collection 1( a) Title of the Information Collection NSPS for VOC Emissions From Petroleum Refinery Wastewater Systems ( 40 CFR part 60, subpart QQQ) ( Renewal)

1( b) Short Characterization/ Abstract The New Source Performance Standards ( NSPS) for petroleum refinery wastewater systems for the regulations published at 40 CFR 60.690 were proposed on May 4, 1987 and promulgated on November 23, 1988. These standards apply to the following affected facilities in petroleum refinery wastewater systems: individual drain systems, oil water separators, and aggregate facilities commencing construction, modification or reconstruction after the date of proposal. An individual drain system consists of all process drains connected to the first downstream junction box. An oil water separator is the wastewater treatment equipment used to separate oil from water. An aggregate facility is an individual drain system together with ancillary downstream sewer lines and oil water separators, down to and including the secondary oil water separator, as applicable. Aggregate facilities are intended to capture any potential volatile organic compound ( VOC) emissions within the petroleum refinery wastewater system during expansions of and additions to the system. There are no additional recordkeeping or reporting requirements for aggregate facilities. For the purposes of this document, new facilities are those affected facilities that have had construction, modification or reconstruction within the last three years. This information is being collected to determine compliance with 40 CFR part 60, subpart QQQ.

In general, all NSPS standards require initial notifications, performance tests, and periodic reports. Owners or operators are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all sources subject to NSPS.

For most of the recordkeeping requirements for this rule any owner or operator subject to the provisions of this part shall maintain a file of these measurements and retain the file for at least two years following the date of such measurements, maintenance reports, and records. However, some records are required to be kept for ten years and other records are required to be kept for the life of the source, or the life of the facility. All reports are sent to the delegated state or local authority. In the event that there is no such delegated authority, the reports are sent directly to 2 the United States Environmental Protection Agency ( EPA) regional office. Once received by the authority, reports are reviewed and the data is entered, analyzed, and maintained in the Air Facility System ( AFS). Information from these reports can be used by any regions, states, agencies and offices with access to AFS and may be used in determining where inspections and enforcement actions may be necessary.

Approximately 135 sources are currently subject to the regulation, and it is estimated that no additional sources will become subject to the regulation in the next three years. It is further assumed that there is an average of two affected facilities per plant. The annual cost of this ICR will be $ 17,550 dollars for non labor and $ 589,385 dollars for labor ( based on a labor burden of 9,237 hours) for a total of $ 606,935 dollars.

These estimates are based on industry journals and industry consultation. The number of refineries has declined since the previous approval due to consolidation and closures, but is not expected to decline further in the next three years. The active ( previous) ICR speculated that the number of refineries would remain constant over the following three years; this estimate appears to have been incorrect.

The active ( previous) ICR had the following Terms of Clearance:

" This Information Collection Request is approved for three years. When EPA resubmits the ICR for renewal, the Agency should update the wage rates and verify that the rates have been properly loaded to include overhead, consistent with current EPA and OMB guidelines."

EPA has addressed each item of concern in the Terms of Clearance by updating the industry and Agency wage rates, based on recent information provided by the Department of Labor ( DOL) and the Office of Personnel Management ( OPM). These rates have been loaded to account for overhead. The updated wage and overhead rates for industry are included in Section 6( b)( i) of this document. The updated wage and overhead rates for the Agency are included in Section 6( c) of this document.

2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection The EPA is charged under Section 111 of the Clean Air Act ( CAA), as amended, to establish standards of performance for new stationary sources that reflect:

. . . application of the best technological system of continuous 3 emissions reduction which ( taking into consideration the cost of achieving such emissions reduction, or any non air quality health and environmental impact and energy requirements) the Administrator determines has been adequately demonstrated. Section 111( a)( l).

The Agency refers to this charge as selecting the best demonstrated technology ( BDT). Section 111 also requires that the Administrator review and, if appropriate, revise such standards every four years.

In the Administrator's judgment, VOC emissions from petroleum refinery wastewater systems cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, the NSPS were promulgated for this source category at 40 CFR part 60, subpart QQQ.

2( b) Practical Utility/ Users of the Data The control of emissions of VOC from petroleum refinery wastewater systems requires not only the installation of properly designed equipment, but also the operation and maintenance of that equipment. Emissions of VOC from petroleum refinery wastewater systems are the result of operation of the affected facilities. The subject standards are achieved by the capture or reduction of VOC emissions using incinerators, flares and carbon adsorbers, and by leak detection and repair procedures. The notifications required in the applicable regulations are used to inform the Agency or delegated authority when a source becomes subject to the requirements of the regulations. The reviewing authority may then inspect the source to check if the pollution control devices are properly installed and operated, leaks are being detected and repaired, and the regulations are being met. Performance test reports are needed as these are the Agency's record of a source's initial capability to comply with the emission standards, and serve as a record of the operating conditions under which compliance was achieved. The required operating conditions for enclosed combustion devices are a VOC destruction efficiency of 95 percent or greater, and/ or a minimum residence time of 0.75 seconds at a minimum temperature of 1,500 degrees Fahrenheit (

F). The required operating condition for vapor recovery systems ( e. g., carbon adsorbers) is a VOC recovery efficiency of 95 percent or greater. The required operating conditions for flares are no visible emissions and flame must be present at all times. The required operating condition for closed vent systems is for emissions to be non detectable, as indicated by an instrument reading of less than 500 parts per million VOC above backgound. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations. The information generated by the monitoring, recordkeeping and reporting requirements described in this ICR is used by the Agency to ensure that facilities affected by the NSPS continue to operate the control equipment in compliance with the regulation. Adequate monitoring, recordkeeping, and reporting are necessary to ensure compliance with the applicable regulations, as required by the Clean Air Act. The information 1 Worldwide Refineries Capacities as of January 1, 2003. Oil & Gas Journal. Penn Well Publishing Company, December 23, 2002.

4 collected from recordkeeping and reporting requirements is also used for targeting inspections, and is of sufficient quality to be used as evidence in court.

3. Nonduplication, Consultations, and Other Collection Criteria The requested recordkeeping and reporting are required under 40 CFR part 60, subpart QQQ.

3( a) Nonduplication If the subject standards have not been delegated, the information is sent directly to the appropriate EPA regional office. Otherwise, the information is sent directly to the delegated state or local agency. If a state or local agency has adopted its own similar standards to implement the federal standards, a copy of the report submitted to the state or local agency can be sent to the Administrator in lieu of the report required by the federal standards. Therefore, no duplication exists.

3( b) Public Notice Required Prior to ICR Submission to OMB An announcement of a public comment period for the renewal of this ICR was published in the Federal Register ( 68 FR 62289) on November 3, 2003. No comments were received on the burden published in the Federal Register.

3( c) Consultations Published industry data, an industry trade association and the EPA database OTIS were used for this ICR. A dataset from the Penn Well Publishing Company ( publishers of Oil & Gas Journal) was the primary source of information regarding the number of existing affected sources1. Also, EPA consulted with Norbert Dee and Tom Wigglesworth of the National Petroleum Refiners Association ( NPRA) at ( 202) 457 0480. They provided information regarding the number of refineries, industry growth rate, level of electronic reporting, and representation of small businesses, as well as anecdotal information regarding industry's opinion of the rule. According to the NPRA, respondents perceive the record keeping and reporting burden as " fairly reasonable." However, the prevailing opinion is that the language of the rule could be clarified. There is some confusion over the definitions of the terms " individual drain system," " aggregate facility," and " stormwater sewer system." Respondents believe that the definition of " oily wastewater" should be revised to include a minimum threshold; the NPRA suggested a threshold concentration of 500 parts per million of organics. Also, there is some confusion over the applicability of the rule. For example, some respondents are unclear as to 5 whether the rule would apply to a source that installs new piping as part of a sewer system.

3( d) Effects of Less Frequent Collection Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the standards. Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met. If the information required by these standards was collected less frequently, the likelihood of detecting poor operation and maintenance of control equipment and noncompliance would decrease.

3( e) General Guidelines None of these reporting or recordkeeping requirements violate any of the regulations established by OMB at 5 CFR 1320.5.

Some records must be kept for the life of the source, or the life of the facility, as required by: 40 CFR 60.697( h) ( stormwater sewer systems exclusion), 40 CFR 60.697( i) ( ancillary equipment exclusion), and 40 CFR 60.697( j) ( non contact cooling water systems exclusion)

Other records must be kept for ten years, as required by: 40 CFR 60.697( k)( 1). This recordkeeping requirement is for alternative standards for certain oilwater separators. It is not mandatory, but voluntary.

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

3( g) Sensitive Questions None of the reporting or recordkeeping requirements contain sensitive questions.

4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes 6 The respondents to the recordkeeping and reporting requirements are the owners or operators of petroleum refinery wastewater systems that commenced construction, modification, or reconstruction after May 4, 1987. The SIC code for the respondents affected by the standards is SIC ( United States Standard Industrial Classification) 2911, which corresponds to NAICS ( North American Industry Classification System) 324110 for petroleum refineries.

The Agency assumes that all petroleum refineries utilize individual drain systems and/ or oil water separators for treatment of wastewater on site, and that each refinery has constructed, reconstructed, or modified at least one component of the wastewater system since May 4, 1987. Therefore, the Agency assumes that all petroleum refineries are respondents to the recordkeeping and reporting requirements.

4( b) Information Requested ( i) Data Items All data in this ICR that are recorded and/ or reported are required by 40 CFR part 60, subpart QQQ  Standards of Performance for VOC Emissions From Petroleum Refinery Wastewater Systems.

A source must make the following reports:

Notification Reports Notification of construction or reconstruction. 60.7( a)( 1)

Notification of modification. 60.7( a)( 4)

Notification of actual startup date. 60.7( a)( 3)

Notification of initial performance test. 60.8( a)

Notification of election to construct and operate a completely closed drain system. 60.693 1( c) and 60.698( a)

Notification of election to construct and operate a floating roof on an oil water separator tank or other subject auxiliary equipment. 60.693 2( b) and 60.698( a)

Notification of intent to use an alternative means of emission limitation. 60.694( c) Notification Reports 7 Notification of intent to use a VOC control device other than a carbon adsorber to meet the requirements of 60.692 5( a), with information describing the control device and the process parameters being monitored. 60.695( b)

Demonstration that an alternative operational or process parameter will ensure that the control device is operated in compliance with standards. 60.695( c)

Initial certification that the requirements for equipment and inspections have been met. 60.698( b)( 1)

Notification of delay in compliance along with the date of the next scheduled refinery or process unit shutdown and reasons why delay is necessary. 60.698( e)

Reports Semiannual reports of excess emissions from and performance of continuous monitoring systems, and/ or summary report forms. 60.7( c) and 60.7( d)

Semiannual certification that required inspections have been carried out. 60.698( b)( 1)

Initial performance test data and result for flares. 60.8( a) and 60.698( b)( 2)

Initial and semiannual inspection reports detailing problems resulting in VOC emissions and the corrective actions taken. 60.698( c)

Semiannual reports on control device performance. 60.698( d)

A source must keep the following records:

Recordkeeping Keep records of startups, shutdowns, and malfunctions of affected facilities; malfunctions of control devices; and periods where the continuous monitoring system is inoperative. 60.7( b) Recordkeeping 8 Keep records of measurements, performance evaluations, calibration checks, adjustments and maintenance related to continuous monitoring systems. 60.7( f)

Keep records of location, date, and corrective actions for process drains not in compliance. 60.697( b)( 1)

Keep records of location, date, and corrective actions for junction boxes out of compliance. 60.697( b)( 2)

Keep records of location, date, and corrective actions for sewer lines out of compliance. 60.697( b)( 3)

Keep records of location, date, and corrective actions for oil water separators out of compliance. 60.697( c)

Keep records of location, date, and corrective actions for closed vent systems and completely closed drain systems out of compliance. 60.697( d)

Keep records of expected date of repairs if emission point cannot be repaired without a process shutdown; reason for delay; signature of company official who authorizes the delay; and the date of actual repairs. 60.697( e)

Keep records of copy of design specifications for all equipment used to comply with the standards. 60.697( f)( 1) and ( 2)

Keep records of information pertaining to the operation and maintenance of closed drain systems and closed vent systems. 60.697( f)( 3)

Keep records of location, plans or specifications for inactive process drains. 60.697( g)

Keep records of location, plans or specifications for exempted stormwater sewer systems. 60.697( h)

Keep records of location, plans or specifications for exempted ancillary equipment. 60.697( i)

Keep records of location, plans or specifications for exempted noncontact cooling water systems. 60.697( j) 2 Consultation with Norbert Dee and Tom Bigglesworth, National Petroleum Refiners Association.

9 Electronic Reporting The majority of the record keeping requirements associated with this rule are related to visual inspections of transport systems and other facilities. Personnel at the affected source must perform these inspections and note the nature of the corrective actions taken. Because of the human labor involved with these requirements, there are few record keeping requirements that could be easily automated. As a result, automated record keeping appears to be rare among respondents. Some regulatory agencies are setting up electronic reporting systems to allow sources to report electronically which is reducing the reporting burden. However, electronic reporting systems are still not widely used by the regulatory agencies. It is believed that electronic reporting is not common among respondents2.

( ii) Respondent Activities Respondent Activities Read instructions.

Install, calibrate, maintain, and operate a continuous temperature monitoring device for thermal or catalytic incinerators; a continuous VOC monitoring device for regenerative carbon adsorbers; and/ or a thermocouple or equivalent device for flares, as applicable.

Perform initial performance test, Reference Method 21 test ( Method 22 for flares), and repeat performance tests if necessary.

Write the notifications and reports listed above.

Enter information required to be recorded above.

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

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

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

Adjust the existing ways to comply with any previously applicable instructions and requirements. Respondent Activities 10 Train personnel to be able to respond to a collection of information.

Transmit, or otherwise disclose the information.

5. The Information Collected: Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities EPA conducts the following activities in connection with the acquisition, analysis, storage, and distribution of the required information.

Agency Activities Observe initial performance tests and repeat performance tests if necessary.

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

Audit facility records.

Input, analyze, and maintain data in the Air Facility System ( AFS).

5( b) Collection Methodology and Management Following notification of startup, the reviewing authority may inspect the source to check if the pollution control devices are properly installed and operated, leaks are being detected and repaired, and the regulations are being met. Performance test reports are needed as these are the Agency's record of a source's initial capability to comply with the emission standards, and serve as a record of the operating conditions under which compliance was achieved. The required operating conditions for enclosed combustion devices are a VOC destruction efficiency of 95 percent or greater, and/ or a minimum residence time of 0.75 seconds at a minimum temperature of 1,500 degrees Fahrenheit (

F). The required operating condition for vapor recovery systems ( e. g., carbon adsorbers) is a VOC recovery efficiency of 95 percent or greater. The required operating conditions for flares are no visible emissions and flame must be present at all times. The required operating condition for closed vent systems is for emissions to be non detectable. Data and records maintained by the respondents are tabulated and published for use in compliance and enforcement programs. The semiannual reports are used for problem identification, as a check on 2 Consultation with Norbert Dee and Tom Bigglesworth, National Petroleum Refiners Association.

11 source operation and maintenance, and for compliance determinations.

Information contained in the reports is entered into the AFS, which is operated and maintained by EPA's Office of Compliance. AFS is EPA's database for the collection, maintenance, and retrieval of compliance data for approximately 125,000 industrial and government owned facilities. EPA uses the AFS for tracking air pollution compliance and enforcement by local and state regulatory agencies, EPA regional offices and EPA headquarters. EPA and its delegated Authorities can edit, store, retrieve and analyze the data.

The records required by this regulation must be retained by the owner or operator for two years.

5( c) Small Entity Flexibility A majority of the affected facilities are large entities ( e. g., large businesses) 2. However, the impact on small entities ( i. e., small businesses) was taken into consideration during the development of the regulation. Due to technical considerations involving the process operations and the types of control equipment employed, the recordkeeping and reporting requirements are the same for both small and large entities. The Agency considers these requirements the minimum needed to ensure compliance and, therefore, cannot reduce them further for small entities. To the extent that larger businesses can use economies of scale to reduce their burden, the overall burden will be reduced.

5( d) Collection Schedule The specific frequency for each information collection activity within this request is shown in Table 1: Annual Respondent Burden and Cost, NSPS for VOC Emissions From Petroleum Refinery Wastewater Systems ( 40 CFR part 60, subpart QQQ).

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

The Agency may not conduct or sponsor, and a person is not required to respond to, a 12 collection of information unless it displays a currently valid OMB Control Number.

6( a) Estimating Respondent Burden The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated to be 9,237 hours ( Total labor hours from Table 1). These hours are based on Agency studies and background documents from the development of the regulation, Agency knowledge and experience with the NSPS program, the previously approved ICR, and any comments received.

6( b) Estimating Respondent Costs ( i) Estimating Labor Costs This ICR uses the following labor rates:

Managerial $ 95.32 ($ 45.39 + 110%) Technical $ 64.60 ($ 30.76 + 110%) Clerical $ 40.09 ($ 19.09 + 110%)

These rates are from the United States Department of Labor, Bureau of Labor Statistics, December, 2003, " Table 10. Private industry, by occupational and industry group." The rates are from column 1, " Total compensation." The rates have been increased by 110% to account for the benefit packages available to those employed by private industry.

( ii) Estimating Capital/ Startup and Operation and Maintenance Costs The type of industry costs associated with the information collection activities in the subject standards are both labor costs which are addressed elsewhere in this ICR and the costs associated with continuous monitoring. The capital/ startup costs are one time costs when a facility becomes subject to the regulation. The annual operation and maintenance costs are the ongoing costs to maintain the monitors and other costs such as photocopying and postage.

The estimated respondent burden associated with capital/ startup and operation and maintenance costs has decreased to less than the current OMB inventory. This difference is the result of a reduction in the number of existing affected sources, a reduction in the number of new sources, the inclusion of controls other than flares, and revisions to operation and maintenance costs. Because there are no new sources expected, capital/ startup costs are expected to be zero.

( iii) Capital/ Startup vs. Operation and Maintenance ( O& M) Costs 2 Consultation with Norbert Dee and Tom Bigglesworth, National Petroleum Refiners Association.

13 The following table presents the respondent costs associated with capital/ startup, and operation and maintenance of the control devices and monitoring systems that are required by 40 CFR part 60, subpart QQQ:

Capital/ Startup vs. Operation and Maintenance ( O& M) Costs ( A) Monitoring Device ( B) Capital/ Startu p Cost for One Respondent ( C) Number of New Respondents ( D) Total Capital/ Startu p Cost, ( B X C) ( E) Annual O& M Costs for One Respondent ( F) Number of Respondents with O& M ( G) Total O& M,

( E X F)

Portable VOC analyzer for Nonregenerative carbon adsorber $ 2,960 0 $ 0 $ 130 135 $ 17,550 Total $ 0 $ 17,550 Cost information in the above table is from the EPA Air Pollution Control Cost Manual, January 2002, " Table 4.10: Cost Summary for Parametric Monitoring of VOCs Using Carbon Adsorption Capacity." The Agency assumes that all respondents utilize VOC controls to comply with the rule. This is believed to be a conservative estimate, as industry consultation indicates that some respondents use covers or floating roofs to avoid the requirements for closed vent systems and control devices2. The Agency bases the cost estimate on the monitoring of nonregenerative carbon adsorbers because this type of control is believed to be common among respondents.

The total capital/ startup costs for this ICR are $ 0. This is the total of column D in the above table. These costs are shown on the OMB 83 I form in block 14( a), Total annualized capital/ startup costs.

The total operation and maintenance ( O& M) costs for this ICR are $ 17,550. This is the total of column G and for reporting purposes will be rounded off to $ 17,600. These costs are shown on the OMB 83 I form in block 14( b), Total annual costs ( O& M).

The total respondent costs in block 14 have been calculated as the addition of the capital/ startup costs, and the annual operation and maintenance costs. The average annual cost for capital/ startup and operation and maintenance costs to industry over the next three years of 2 Norbert Dee and Tom Bigglesworth, National Petroleum Refiners Association.

14 the ICR is estimated to be $ 17,600. This cost is shown on the OMB 83 I form in block 14( c), Total annualized cost requested. The numbers in block 14 of the OMB 83 I form are rounded to show the cost in thousands of dollars.

6( c) Estimating Agency Burden and Cost The only costs to the Agency are those costs associated with analysis of the reported information. EPA's overall compliance and enforcement program includes activities such as the examination of records maintained by the respondents, periodic inspection of sources of emissions, and the publication and distribution of collected information.

The average annual Agency cost during the three years of the ICR is estimated to be $ 98,254 [ See Table 2 in Section 6( d)].

This cost is based on the average hourly labor rate as follows:

Managerial $ 54.66 ( GS 13, Step 5, $ 34.16 x 1.6) Technical $ 40.56 ( GS 12, Step 1, $ 25.35 x 1.6) Clerical $ 21.95 ( GS 6, Step 3, $ 13.72 x 1.6)

These rates are from the Office of Personnel Management ( OPM) " 2004 General Schedule," which excludes locality rates of pay. Details upon which this estimate is based appear in Table 2: Annual Agency Burden and Cost, NSPS for VOC Emissions From Petroleum Refinery Wastewater Systems ( 40 CFR Part 60, Subpart QQQ), below.

6( d) Estimating the Respondent Universe and Total Burden and Costs Based on our research for this ICR, approximately 135 existing sources are currently subject to the standard. It is estimated that no additional sources will become subject to the standard in the next three years; no new refineries have been constructed in nearly 30 years, and existing sources rarely need to construct new wastewater facilities2. None of the existing sources have new facilities ( no change year to year). All subject sources are required to keep records and submit reports. The number of affected sources has declined in recent years due to consolidation and closures but is not expected to decline further in the next three years. 15 The number of respondents is calculated using the following table, which addresses the three years covered by this ICR:

Number of Respondents Respondents That Submit Reports Respondents That Do Not Submit Any Reports Year ( A) Number of New Respondents 1 ( B) Number of Existing Respondents ( C) Number of Existing Respondents that keep records but do not submit reports ( D) Number of Existing Respondents That Are Also New Respondents ( E) Number of Respondents ( E= A+ B+ C D)

1 0 135 0 0 135 2 0 135 0 0 135 3 0 135 0 0 135 Average 0 135 0 0 135 1 New respondents include sources with constructed, reconstructed and modified affected facilities. In this standard, existing respondents submit initial notifications.

To avoid double counting respondents, column D is subtracted. As shown above, the average Number of Respondents over the three year period of this ICR is 135. This number appears on the OMB 83 I form in block 13( a), Number of respondents.

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

Total Annual Responses ( A)

Information Collection Activity ( B)

Number of Respondents ( C)

Number of Responses ( D) Number of Existing Respondents That Keep Records But Do Not Submit Reports ( E) Total Annual Responses E=( BxC)+ D Total Annual Responses 16 Notification of construction/ reconstruction 0 1 N/ A 0 Notification of modification 0 1 N/ A 0 Notification of actual start up 0 1 N/ A 0 Initial certification of equipment and inspections 0 1 N/ A 0 Initial inspection report detailing emission problems 0 1 N/ A 0 Various notifications of intent1 0 1 N/ A 0 Demonstration for alternative operational or process parameter 0 1 N/ A 0 Notification of delay in compliance 0 1 N/ A 0 Semiannual report 135 2 0 270 Notification of initial performance test 0 1 N/ A 0 Total 270 1 This includes review of the following notifications: election to construct and operate a completely closed drain system; election to construct and operate a floating roof; intent to use an alternative means of emission limitation; and intent to use a VOC control device other than a carbon adsorber to meet the requirements of 60.692 5( a).

The number of Total Annual Responses is 270. This number is shown on the OMB 83 I form in block 13( b), Total annual responses.

The Total Hours Requested is shown on the OMB 83 I form in block 13( c). The total annual labor costs are $ 589,385. The annual labor costs are not shown on the OMB 83 I form. Details regarding these estimates may be found in Table 1: Annual Respondent Burden and Cost, NSPS for VOC Emissions From Petroleum Refinery Wastewater Systems ( 40 CFR part 60, subpart QQQ).

6( e) Bottom Line Burden Hours Burden Hours and Cost Tables The detailed bottom line burden hours and cost calculations for the respondents and the 17 Agency are shown in Tables 1 and 2, respectively, and summarized below.

( i) Respondent Tally The Total Hours Requested is shown on the OMB 83 I form in block 13( c). The total annual labor costs are $ 589,385. The annual labor costs are not shown on the OMB 83 I form. Details regarding these estimates may be found in Table 1: Annual Respondent Burden and Cost, NSPS for VOC Emissions From Petroleum Refinery Wastewater Systems ( 40 CFR part 60, subpart QQQ). Furthermore, the annual public reporting and recordkeeping burden for this collection of information is estimated to average 34.2 hours per response.

The total annual capital/ startup and O& M costs to the regulated entity are $ 17,500. This number is shown on the OMB 83 I form in block 14( c), Total annualized cost requested. The cost calculations are detailed in Section 6( b)( iii), Capital/ Startup vs. Operation and Maintenance ( O& M) Costs.

( ii) The Agency Tally The average annual Agency burden and cost over the next three years is estimated to be 2,484 labor hours at a cost of $ 98,254. See Table 2: Annual Agency Burden and Cost, NSPS for VOC Emissions From Petroleum Refinery Wastewater Systems ( 40 CFR part 60, subpart QQQ).

6( f) Reasons for Change in Burden The decrease in burden from the most recently approved ICR is due to adjustments. The adjustment decrease in burden from the most recently approved ICR is primarily due to a decrease in the number of sources and a more accurate ( decreased) estimate of the number of anticipated new sources. Because there are no new sources anticipated, there is no expected burden resulting from capital/ startup costs, initial notifications, or initial performance tests. These revisions led to decreases in burden that offset increases in burden resulting from other revisions. Revisions leading to increases in burden included use of updated labor rates, inclusion of managerial and clerical hours in addition to technical hours, use of updated O& M costs, inclusion of O& M costs for control devices other than flares, and inclusion of burden associated with notification and reporting requirements that were omitted from the current ICR.

The estimated respondent burden associated with capital/ startup and operation and maintenance costs has decreased to less than the current OMB inventory. This difference is the result of a reduction in the number of existing affected sources, a reduction in the number of new sources, the inclusion of controls other than flares, and revisions to operation and maintenance costs. Because there are no new sources expected, capital/ startup costs are expected to be zero. 18 6( g) Burden Statement The annual public reporting and recordkeeping burden for this collection of information is estimated to average 34.2 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB Control Number. The OMB Control Numbers for EPA's regulations are listed at 40 CFR Part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number OECA 2003 0145, which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Avenue, NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Enforcement and Compliance Docket and Information Center is ( 202) 566 1752. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select " search," then key in the Docket ID Number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number OECA 2003 0145 and OMB Control Number 2060 0172 in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information. 19 20 Table 1: Annual Respondent Burden and Cost, NSPS for VOC Emissions From Petroleum Refinery Wastewater Systems ( 40 CFR part 60, subpart QQQ)

Activity ( A) Technical Hrs/ Occurrence ( B) Occurrences/

Respondent/

Yr. ( C) Hours/ Respondent/

Yr. ( D) Number of Respondents ( E) Technical Hrs/ Yr.

( E = C x D) ( F) Management Hours/ Yr.

( F = 0.05 x E) ( G) Clerical Hours/ Yr.

( G = 0.1 x ( H) Total Labor Costs/

1. Applications Not applicable 2. Survey and Studies Not applicable 3. Reporting Requirements A. Read instructions 2 1 2 135 270 13.5 27 19,811 B. Required activities i. Inspect drain systems 2 12 24 135 3,240 162 324 237,735 ii. Inspect O/ W separators 8 2 16 135 2,160 108 216 158,490 iii. Performance test 330 0 0 0 0 0 0 0 C. Create information See 3B D. Gather existing information See 3E E. Write reports i. Notification of construction/

reconstruction 2 0 0 0 0 0 0 0 ii. Notification of modification 2 0 0 0 0 0 0 0 iii. Notification of actual start up 2 0 0 0 0 0 0 0 iv. Initial certification of equipment and inspections 2 0 0 0 0 0 0 0 v. Initial inspection report detailing emission problems 2 0 0 0 0 0 0 0 vi. Various notifications of intent2 2 0 0 0 0 0 0 0 Activity ( A) Technical Hrs/ Occurrence ( B) Occurrences/

Respondent/

Yr. ( C) Hours/ Respondent/

Yr. ( D) Number of Respondents ( E) Technical Hrs/ Yr.

( E = C x D) ( F) Management Hours/ Yr.

( F = 0.05 x E) ( G) Clerical Hours/ Yr.

( G = 0.1 x ( H) Total Labor Costs/

21 vii. Demonstration for alternative operational or process parameter 2 0 0 0 0 0 0 0 viii. Notification of delay in compliance 2 0 0 0 0 0 0 0 ix. Semiannual report 8 2 16 135 2,160 108 216 158,490 x. Notification of initial 2 0 0 0 0 0 0 0 xi. Results of performance test See 3B 4. Recordkeeping Requirements A. Read instructions See 3A B. Plan activities Not applicable C. Implement activities Not applicable D. Develop record system Not applicable E. Enter information 1.5 1 1.5 135 202.5 10.13 20.25 14,859 F. Train personnel Not applicable G. Perform audits Not applicable TOTAL LABOR BURDEN AND COST ( rounded) 9,237 hours $ 589,385 1 This cost is based on the sum of personnel hours multiplied by their hourly labor rates [( Technical hours x $ 64.60) + ( Management hours x $ 95.32) +

( Clerical hours x $ 40.09)].

2 This includes review of the following notifications: election to construct and operate a completely closed drain system; election to construct and operate a floating roof; intent to use an alternative means of emission limitation; and intent to use a VOC control device other than a carbon adsorber to meet the requirements of 60.692 5( a). 22 Table 2: Annual Agency Burden and Cost, NSPS for VOC Emissions From Petroleum Refinery Wastewater Systems ( 40 CFR part 60, subpart QQQ)

Activity ( A) Technical Hrs/ Occurrence ( B) Occurrences/

Respondent/

Yr. ( C) Hours/ Respondent/ Yr.

( C = A x B) ( D)

# Respondents ( E) Technical Hrs/

Yr.

( E = C x D) ( F) Management Hours/ Yr.

( F = 0.05 x E) ( G) Clerical Hours/ Yr.

( G = 0.1 x E) ( H)

Total Labor Costs/ Yr.

($) 1 1. Review of notification of construction/ reconstruction 2 0 0 0 0 0 0 0 2. Review of notification of modification 2 0 0 0 0 0 0 0 3. Review of notification of actual start up 2 0 0 0 0 0 0 0 4. Review of initial certification for equipment and inspections 2 0 0 0 0 0 0 0 5. Review of initial inspection report detailing emission problems 2 0 0 0 0 0 0 0 6. Review of various notifications of intent2 2 0 0 0 0 0 0 0 7. Review of demonstration for alternative 2 0 0 0 0 0 0 0 Activity ( A) Technical Hrs/ Occurrence ( B) Occurrences/

Respondent/

Yr. ( C) Hours/ Respondent/ Yr.

( C = A x B) ( D)

# Respondents ( E) Technical Hrs/

Yr.

( E = C x D) ( F) Management Hours/ Yr.

( F = 0.05 x E) ( G) Clerical Hours/ Yr.

( G = 0.1 x E) ( H)

Total Labor Costs/ Yr.

($) 1 23 operational or process parameter 8. Review of notification of delay in compliance 2 0 0 0 0 0 0 0 9. Review of notification of initial performance test 2 0 0 0 0 0 0 0 10. Review of initial performance test report for flares 2 0 0 0 0 0 0 0 11. Attend performance test 120 0 0 0 0 0 0 0 12. Attend performance retests3 188 0 0 0 0 0 0 0 13. Review of semiannual reports 8 2 16 135 2,160 108 216 98,254 TOTAL LABOR BURDEN AND COST ( rounded) 2,484 hours $ 98,254 1 This cost is based on the sum of personnel hours multiplied by their hourly labor rates [( Technical hours x $ 40.56) + ( Management hours x $ 54.66) +

( Clerical hours x $ 21.95)].

2 This includes review of the following notifications: election to construct and operate a completely closed drain system; election to construct and operate a floating roof; intent to use an alternative means of emission limitation; and intent to use a VOC control device other than a carbon adsorber to meet the requirements of 60.692 5( a).

3 The Agency burden of 188 person hours per retest reflects 16 hours for a notice and a conference; 120 hours to attend the retest; 40 hours for compliance order preparation; and 12 hours for delays in testing that occur at an estimated 10% of retests.


[Federal Register Volume 84, Number 168 (Thursday, August 29, 2019)]
[Notices]
[Pages 45505-45506]
[FR Doc No: 2019-18698]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2019-0704]

Cooperative Research and Development Agreement: Cell Phone
Geolocation for USCG Search and Rescue

AGENCY: Coast Guard, DHS.

ACTION: Notice of intent; request for public comments.

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SUMMARY: The Coast Guard announces its Cooperative Research and
Development Agreement (CRADA) with Callyo 2009 Corporation, to
investigate the potential operational use of leveraging smart phone
technology, specifically the phone's location services, to help locate
mariners in distress more efficiently. The CRADA with Callyo 2009
Corporation is based on market research and visits to vendors with
advertised expertise in this unique application of technology in the
maritime environment for Search and Rescue. While the Coast Guard is
currently partnering with Callyo 2009 Corporation, the agency is
soliciting public comment on the possible nature of and participation
of other parties in the proposed CRADA. In addition, the Coast Guard
also invites other potential non-Federal participants, who have the
interest and capability to bring similar contributions to this type of
research, to consider submitting proposals for consideration in similar
CRADAs.

DATES: Comments must be submitted to the online docket via http://www.regulations.gov on or before September 9, 2019.
    Synopses of proposals regarding future CRADAs must reach the Coast
Guard (see FOR FURTHER INFORMATION

CONTACT) on or before September 9, 2019.

ADDRESSES: Submit comments online at http://www.regulations.gov in
accordance with website instructions.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice
or wish to submit proposals for future CRADAs, contact Sekaran
Jambukesan, Project Official, C5I Branch, U.S. Coast Guard Research and
Development Center, 1 Chelsea Street, New London, CT 06320, telephone
860-271-2884, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We request public comments on this notice. Although we do not plan
to respond to comments in the Federal Register, we will respond
directly to commenters and may modify our proposal in light of
comments.
    Comments should be marked with docket number USCG-2019-0704 and
should provide a reason for each suggestion or recommendation. You
should provide personal contact information so that we can contact you
if we have questions regarding your comments; but please note that all
comments will be posted to the online docket without change and that
any personal information you include can be searchable online (see the
Federal Register Privacy Act notice regarding our public dockets, 73 FR
3316, Jan. 17, 2008). We also accept anonymous comments.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the Coast Guard
(see FOR FURTHER INFORMATION CONTACT). Documents mentioned in this
notice, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that website's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.
    Do not submit detailed proposals for future CRADAs to the Docket
Management Facility. Instead, submit them directly to the Coast Guard
(see FOR FURTHER INFORMATION CONTACT).

Discussion

    CRADAs are authorized under 15 U.S.C. 3710(a).\1\ A CRADA promotes
the transfer of technology to the private sector for commercial use, as
well as specified research or development efforts that are consistent
with the mission of the Federal parties to the CRADA. The Federal party
or parties agree with one or more non-Federal parties to share research
resources, but the Federal party does not contribute funding.
---------------------------------------------------------------------------

    \1\ The statute confers this authority on the head of each
Federal agency. The Secretary of DHS's authority is delegated to the
Coast Guard and other DHS organizational elements by DHS Delegation
No. 0160.1, para. II.B.34.
---------------------------------------------------------------------------

    CRADAs are not procurement contracts. Care is taken to ensure that
CRADAs are not used to circumvent the contracting process. CRADAs have
a specific purpose and should not be confused with procurement
contracts, grants, and other type of agreements.
    Under this CRADA, the R&D Center will collaborate with a non-
Federal participant. Together, the R&D Center and the non-Federal
participant will collect information/data for performance, reliability,
maintenance requirements, human systems integration and other data on
using smart phone's location services for geolocation.
    We anticipate the Coast Guard's contributions under this CRADA will
include the following:
    (1) Research by the parties under this CRADA will be performed
offsite at Callyo 2009 Corporation's facilities and the RDC.
    (2) Provide web based support at the following locations:

CG Sector New York: Staten Island, NY
CG Sector Long Island Sound: New Haven, CT
CG Sector Boston: Boston, MA
CG Sector Southeastern New England: Woods Hole, MA
CG Sector Northern New England: South Portland, ME

We anticipate that the non-Federal participant's contributions under
this CRADA will include the following:
    (1) Provide technical support, training and maintenance throughout
the period of performance to ensure maximum availability and utility of
Callyo 2009 Corporation i911 web based solution.
    (2) Deployment of the Callyo 2009 Corporation i911 capability,
including the interface to the RapidSOS NG911 Clearinghouse, at each CG
Sector.
    The Coast Guard reserves the right to select for CRADA participants
all, some, or no proposals submitted for this CRADA. The Coast Guard
will provide no funding for reimbursement of proposal development
costs. Proposals and any other material submitted in response to this
notice will not be returned. Proposals submitted are expected to be
unclassified and have no more than five single-sided pages.
    The Coast Guard will select proposals at its sole discretion on the
basis of:
    (1) How well they communicate an understanding of, and ability to
meet, the proposed CRADA's goal; and
    (2) How well they address the following criteria:
    (a) Technical capability to support the non-Federal party
contributions described; and
    (b) Resources available for supporting the non-Federal party
contributions described.
    Currently, the Coast Guard entered a CRADA with Callyo 2009
Corporation for participation in this CRADA. This consideration is
based on the fact that Callyo 2009 Corporation has demonstrated its
technical ability as the developer, manufacturer, and integrator of
cellular direction finding equipment. However, we do not wish to
exclude other viable participants from this or future similar CRADAs.
    The CRADA with Callyo 2009 Corporation is based on market research
and visits to vendors with advertised expertise in this operational use
of cellular phone geolocation technology.
    This is a technology assessment effort. The goal for the Coast
Guard of this CRADA is to better understand the advantages,
disadvantages, required technology enhancements, performance, costs,
and other issues associated with cellular direction finding
technologies. Special consideration will be given to small business
firms/consortia, and preference will be given to business units located
in the U.S. This document is issued under the authority of 5 U.S.C.
552(a).

    Dated: August 15, 2019.
Bert N. Macesker,
Executive Director, U.S. Coast Guard Research and Development Center.
[FR Doc. 2019-18698 Filed 8-28-19; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: October 30, 2008 (Volume 73, Number 211)]
[Notices]
[Page 64641]
[DOCID:fr30oc08-78]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Regulation BTR; OMB Control No. 3235-0579; SEC File No. 270-521.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission
(``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Regulation Blackout Trade Restriction (``Regulation BTR'') (17 CFR
245.100-245.104) clarifies the scope and application of Section 306(a)
of the Sarbanes-Oxley Act of 2002 (``Act'') (15 U.S.C. 7244(a)).
Section 306(a)(6) (15 U.S.C. 7244(a)(6)) of the Act requires an issuer
to provide timely notice to its directors and executive officers and to
the Commission of the imposition of a blackout period that would
trigger the statutory trading prohibition of Section 306(a)(1)(15
U.S.C. 7244(a)(1)). Approximately 1,230 issuers file Regulation BTR
notices annually. We estimate that it takes 2 hours per response for an
issuer to draft a notice to directors and executive officers for a
total annual burden of 2,460 hours. The issuer prepares 75% of the
2,460 annual burden hours for a total reporting burden of (1,230 x 2 x
.75) 1,845 hours. In addition, we estimate that an issuer distributes a
notice to five directors and executive officers at an estimated 5
minutes per notice (1,230 blackout period x 5 notices x 5 minutes) for
a total reporting burden of 512 hours. The combined annual reporting
burden is (1,845 hours + 512 hours) 2,357 hours.
    Written comments are invited on: (a) Whether this collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information will have practical
utility; (b) the accuracy of the agency's estimate of the burden
imposed by the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Lewis W. Walker, Acting
Director/CIO, Securities and Exchange Commission, C/O Shirley
Martinson, 6432 General Green Way, Alexandria, Virginia 22312; or send
an e-mail to<EMAIL_ADDRESS>
    Dated: October 22, 2008.
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-25866 Filed 10-29-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 157 (Thursday, August 13, 2020)]
[Notices]
[Pages 49383-49385]
[FR Doc No: 2020-17714]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1298]

Acute Myeloid Leukemia: Developing Drugs and Biological Products
for Treatment; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Acute
Myeloid Leukemia: Developing Drugs and Biological Products for
Treatment.'' This draft guidance is intended to assist sponsors in the
clinical development of drugs and biological products for the treatment
of acute myeloid leukemia (AML). This draft guidance addresses FDA's
current thinking regarding the overall development program and clinical
trial designs for the development of drugs and biological products to
support an indication of treatment of AML, including indications
limited to an individual phase of treatment (for example, maintenance,
transplantation preparative regimen, etc.). The draft guidance
addresses the topics of general drug development, efficacy endpoints,
and exploratory and confirmatory trial considerations for AML drug
development. In addition, the draft guidance addresses investigational
new drug applications, new drug applications, and biologics licensing
applications for AML drugs.

DATES: Submit either electronic or written comments on the draft
guidance by October 13, 2020 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-2020-D-1298 for ``Acute Myeloid Leukemia: Developing Drugs and
Biological Products for Treatment.'' 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.
     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.
    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
Division of Drug Information, CDER, Food and Drug Administration, 10001
New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002 or the Office of Communication, Outreach and Development,
CBER, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71,
Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. The
draft guidance may also be obtained by mail by calling CBER at 1-800-
835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Donna Przepiorka, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2116, Silver Spring, MD 20993-0002, 301-
796-5358; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Acute Myeloid Leukemia: Developing Drugs and Biological
Products for Treatment.'' This draft guidance is intended to assist
sponsors in the clinical development of drugs and biological products
for the treatment of AML. This draft guidance includes FDA's current
thinking regarding the overall development program and clinical trial
designs to support an indication of treatment of AML, including
indications limited to an individual phase of treatment.
    New classes of drugs are being developed as alternatives to the
standard cytotoxic drugs for the treatment of AML. The following
factors contribute substantially to the complexity of clinical
development programs for such new drugs: The expansion of treatment
intent, broadening of the intended population, and development of a
wide range of new drug classes as alternatives to cytotoxic drugs. This
draft guidance includes FDA's thinking regarding general drug
development considerations, efficacy endpoints, exploratory and
confirmatory trial considerations, and regulatory submissions for AML
drugs to facilitate the development of new drugs for the treatment of
AML.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Acute
Myeloid Leukemia: Developing Drugs and Biological Products for
Treatment.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The
collections of information in 21 CFR 312 have been approved under OMB
control number 0910-0014; the collections of information in 21 CFR part
314 have been approved under OMB control number 0910-0001; the
collections of information in 21 CFR part 601 have been approved under
0910-0338; and the collections of information in 21 CFR 201.56 and
201.57 have been approved under OMB control number 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: August 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17714 Filed 8-12-20; 8:45 am]
BILLING CODE 4164-01-P