One commenter 280 stated that capital costs for island facilities are 1.3 to 2.3 times higher on average.  One commenter 280 stated that island facilities transport almost all products by marine vessels, have large MTVLO, must build and operate their own utilities, do not have access to natural gas, and secondary emissions are higher.
      Commenter 280 noted that EPA created the offshore loading terminal subcategory in 1995 because of these differences and the extreme costs.  The commenter reiterated their comments submitted for the 1995 MACT and noted the comments are accurate today.[2]  Commenters 280, 359 stated that nothing has changed since 1995 to justify the changed conclusion on costs and cost effectiveness.
      Response  62:  As discussed in the soon to be published Federal Register notice preamble, the final rule does not include the proposed vapor recovery requirements.  We have reviewed the comments on the beyond-the-floor costs for offshore loading, and we agree that capital costs for offshore loading are likely higher than those for onshore MTVLO terminals, but we do not have any other information than that supplied by the commenters.  We agree that offshore loading should be considered separately based on higher costs and have costed them separately.  We included emission levels at offshore loading facilities based on the emission factor for ship loading, because MTVLO at offshore facilities are more likely to load ships than barges, and the emission rate would be lower.  See additional cost analysis discussion for offshore loading in the cost memorandum.
      In regards to island facilities, we did not analyze this. The commenter expressed concerns that island facilities have higher costs.  Island or remote facilities likely have similar, but possibly somewhat less, logistic and cost issues as offshore facilities that we considered above.

      Comment  63:  Commenter 359 noted that EPA did not demonstrate any benefit from applying control requirements to offshore facilities, and EPA did not assess the nature and fate of the emission to determine if emissions would reasonably be anticipated to endanger public health or contribute to ozone non-attainment status.
      Response  63:  The final submerged fill requirements are for previously unregulated emission sources and thus we are required to set technology standards under CAA section 112(d) (3) standards.  The CAA section 112(d)(3) requires that the MACT floor for existing sources not be less stringent than "the average emission limitation achieved by the best performing 12 percent of the existing sources."  Submerged fill is the MACT floor for two subcategories, as discussed in the October 21, 2010 proposal preamble.

      Comment  64:  One commenter 280 provided updated cost information for a vapor combustion unit [for 54 million bbl/yr island loading facility] of $67 million in TCI and $15 million in TAC for a MTVLO with an annual gasoline throughput of 54 million bbl/yr.  The commenter estimated the cost effectiveness of HAP reductions as $106,000/ton HAP and VOC reductions as $7,700 per ton VOC, and noted the cost effectiveness could be higher.  Commenter 280 noted the beyond-the-floor option for offshore loading is not cost effective.  The commenter 280 does not agree that MACT beyond-the-floor controls should be judged by a criteria pollutant, and noted that secondary emission impacts from operation of the control device and associated utilities should also be considered.
      The commenter states that if additional controls were cost justified for offshore loading terminals based on emissions reductions, the $67 million capital cost is economically infeasible and thus qualifies for treatment under section 112(h). This approach is similar to that included in the rule preamble for Gas 1 Boiler MACT units.
      Commenter 280 noted that a vapor recovery system would be 2.5 to 3 times more costly to build [than a combustion system].  A vapor recovery system would have a VOC cost effectiveness over $13,000/ton VOC and a HAP cost effectiveness of over $177,000/ton HAP.
      Response  64:  We appreciate the input on capital and annualized costs for combustion units for offshore loading.  We do not require that a particular control technology be installed, so a facility would install any control technology that meets a MACT requirement.  We costed a lean oil absorption system as an appropriate, applicable control technology (see Technical Issues below) and that is lower cost.  As discussed in the soon to be published Federal Register preamble, we are not requiring this proposed additional vapor recovery option.

Comment  65:  Commenter 274 noted that many Ozone Transport Commission (OTC) states have lowered the threshold for control of emissions from gasoline loading and have adopted VOC reduction requirements, and the commenter provided a summary of regulations in an attachment to their comment letter.  The thresholds in OTC rules varied from 15,000 gal/day to 6,000,000 gal/day loading (one was 60,000 gal/day in ozone season), control efficiencies varied from 90 to 98 percent VOC reductions, and some rule limited emissions to 2 lb VOC/1000 bbl loaded.  The commenter recommended EPA conduct a review of other state regulations in consideration of strategies to reduce ozone levels.  The commenter further suggested a lowering of the gasoline loading threshold below the proposed 1 million bbl/yr threshold.
      One commenter 297 stated that the proposed rule of 97 percent control is not the best MACT standard that is currently feasible, cost-effective, and available.  The commenter stated that EPA failed to require technologies that eliminate 100 percent of emissions, such as several off-the-shelf Zero Emission Technologies, and failed to require technologies that are 99+ percent effective in capturing emissions and fugitives for ship and land storage tanks, conveyance systems, and connection nozzles.  The commenter requested that EPA research, identify, ascertain and establish a list of available Zero Emission Technologies and MACT Vapor Recovery Systems that could be used for compliance to this proposed ruling.
      The commenter noted that EPA failed to require a secondary enclosure or encasement device to prevent fugitive emissions from escaping from leaking valve connections.
      One commenter 297 recommended that EPA adopt work practices and procedures that would identify, track and require mandatory periodic replacement of frequent equipment, systems, and parts failures, because it is common petroleum industry practice to wait for something to break.  Equipment is subject to metal fatigue, embrittlement, and breakdown.
      Response  65:  We appreciate the information regarding additional rules that support our determination of controlled HAP emissions from gasoline loading at 1 million bbl/yr or less.  The commenter did not provide the data to support those vapor recovery rules.  We believed they are based on VOC reductions and cost effectiveness.  From our analysis, we do not believe additional vapor controls are cost effective for HAP reductions beyond the current standard.
      While we have conducted searches to identify zero emission technologies for control of HAP emissions from MTVLO, the searches revealed mostly zero emission technologies related to combustion emission sources, and not for MTVLO.  Thus, we do not have, nor did the commenter provide, any specific technologies and environmental benefits and costs to assess these technologies for MTVLO.  While one commenter recommended work practices that require mandatory replacement of equipment, the commenter did not provide data on failure frequencies or rates, costs, or environmental impacts on which to evaluate the commenter's suggestion.  Additionally, current Coast Guard rules include safe handling practices and operations that may address these issues.  See 92 FR 25005; May 13, 1994, Background and History for Proposal of the Coast Guard and EPA Standards.

      Comment  66:  Two commenters (359, 264) indicated that §63.560(f) needs corrections related to submerged fill requirements.
      One commenter (359) noted that EPA indicated that the submerged fill requirement would be applied to existing facilities below the 10/25 tpy threshold by a new paragraph §63.560(f), however, in the actual rule language submerged fill is proposed only for offshore facilities.  Commenter (359) noted that proposed edits to §63.560(a)(1), (2), and (3) refer to a paragraph (f) "of this section" but paragraph (f) does not exist.
      Commenter (264) stated that a correction is needed in the proposed language of subpart Y to add a new paragraph §63.560(f) concerning the submerged loading requirement for 2 subcategories (i.e., those facilities emitting less than 10/25 TPY of HAP and those facilities located more than 0.5 miles from shore) and to reference the new provisions in §63.562(f)(1) or (f)(2) for marine terminals that load more than 1 million bbl/yr of gasoline.
	Response  66:  We appreciate the commenters pointing out the omission of §63.560(f) in the proposed rule text.  We mistakenly omitted this paragraph but did include the text in the docket (see Docket item EPA-HQ-OAR-2010-0600-0253).  In the final rule, we are adding the submerged fill requirement to a new subparagraph §63.560(a)(4) for sources with MTVLO emissions less than 10/25 tpy HAP.  (The same submerged fill requirements are also included in the final rule for offshore loading in §63.560(d)(6).)  No new paragraph §63.560(f) will be added to the rule.

	Comment  67:  One commenter (359) noted that the proposed edits to §63.562(b)(1)(i) should read "1 million bbl/yr of gasoline" rather than "1 M barrels of gasoline," so as to read correctly and to be consistent with proposed edits to §63.562(b)(1)(ii) and (iii).
One commenter (359) stated that while proposed edits to §63.562(b)(1) would apply the vapor collection and vapor-tightness requirements to facilities that load at least 1 M bbl/yr of gasoline, the control standard for these facilities is specified separately in a proposed new paragraph §63.562(f). The commenter explained that the manner in which this is done results in the following provisions not being applicable to the new subcategory:	(1)  §63.562(b)(5) Prevention of carbon adsorber emissions during regeneration.	(2)  §63.562(b)(6) Maintenance allowed for loading berths. 	(3)  §63.563(b) Compliance determination for affected sources (initial performance test).  	The commenter explained that it is not apparent whether EPA intended for these provisions to not apply to the new subcategory of facilities that load at least 1 M bbl/yr of gasoline.
      Response  67:  We appreciate the commenter's questions on certain rule provisions being applicable to existing sources with MTVLO emissions less than 10/25 tpy and loading 1 million bbl/yr of gasoline, however, the final rule does not include the vapor recovery requirements.  The proposed vapor recovery requirements paragraph in §63.562(f), and the proposed changes to §63.562(b)(1) are not in the final rule.

      Comment  68:  One commenter (359) noted that the proposed edits to Table 1, at §63.10(c)(10) and (11), include a reference to §63.657(m)(1) for reporting malfunctions but no paragraph §63.657(m) exists.
      Response  68:  We appreciate the commenters pointing out the omission of §63.567(m) in the proposed rule text.  We mistakenly omitted this paragraph.  In the final rule, we are adding a new paragraph in §63.567(m) for reporting malfunctions.  This paragraph is similar to malfunction paragraphs in other rules included in the proposal (e.g., in subpart KK, §63.829(b)(6)(v); and in subpart CCC, §63.1164(c)).

      Comment  69:  Commenter (264) recommended that EPA clarify that §63.562(e) does not apply to existing sources with emissions less than 10 and 25 tons (since the emission limits do not apply) and that only §§63.560(f)(1) [new section], 63.567(j)(4) and 63.565(l) apply as per §63.560(a)(3).  As proposed, §63.56[0](a)(2) states that existing sources with emissions less than 10 and 25 tons are not subject to the emission standards in §63.562(b) and (d), except as specified in paragraph (f) [submerged fill].  The commenter noted §63.56[0](a)(3) implies that only the recordkeeping requirements in §63.567(j)(4) and the emission estimation requirements in §63.565(l) apply to these sources, except as specified in paragraph (f) [submerged fill].  Commenter (0264) noted that the way §63.560(a)(2) is worded, one might conclude that §63.562(e) applies to existing sources with emissions less than 10 and 25 tons. However, §63.560(a)(3) could again lead one to conclude that only those citations mentioned are applicable to sources with emissions less than 10 and 25 tons.
      Because the emission standards do not apply to existing sources with emissions less than 10 and 25 tons, the commenter suggested that one could conclude the operation and maintenance requirements in §63.562(e) for air pollution control equipment and monitoring equipment do not apply either.
      Commenter (264) noted that the proposed changes to the Marine MACT include adding paragraph (7) to §63.562(e) to address recordkeeping and reporting requirements during periods of malfunction.  The rule also is proposing an affirmative defense against civil penalties for exceedances of emission standards caused by malfunctions, as well as the criteria for establishing the affirmative defense.  Because §63.560(a)(2) specifically states that the emission standards in §63.562(b) and (d) do not apply to existing sources with emissions less than 10 and 25 tons, then the affirmative defense requirements proposed in §63.562(e)(7) for exceedances of the emission standards caused by malfunctions should not apply either.  The commenter recommended that the language in §63.560(a)(3) be revised:
      (a)(3) Only the recordkeeping requirements in §63.567(j)(4) and the emission estimation requirements of §63.565(l) apply to existing sources with emissions less than 10 and 25 tons, except as specified in paragraph (f) of this section. No other requirements in this subpart apply to existing sources with emissions less than 10 and 25 tons.
      Response 69:  We have reviewed the comments and we believe that the current and final §63.562(e) "operation and maintenance requirements for air pollution control equipment and monitoring equipment for affected sources" are applicable to existing sources with MTVLO emissions less than 10/25 tpy and are now subject to submerged fill requirements.  The proposed and the current language of §63.562(e) provides "owner and operators of affected sources shall operate and maintain a source, including associated air pollution control equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions".  Additionally, submerged fill reduces the generation of vapor emissions, so it is considered air pollution control equipment as well as process equipment. Thus, it applies to both "control equipment" and the "source" and is not limited to, as the commenter says, to "emission limits" and "air pollution control equipment."  Additionally, we believe the added subparagraph (§63.562(e)(7)) for malfunctions is applicable for the same reasons stated above.
      We do not believe §63.560(a)(2) and (3) specify requirements for emission estimation and recordkeeping as the "only" requirements since the current rule text does not use "only."  However, for clarity, instead of revising the subparagraphs to add the submerged fill requirement as we did in the proposal rule text, we are adding the submerged fill requirement as a new subparagraph §63.560(a)(4) in the final rule.

      Comment  70:  One commenter (264) requested that in the emission estimation procedures under §63.565(l), EPA clarify that the exclusion for "Commodities Exempted by §63.560(d)" was intended to mean that annual HAP emissions do not need to be estimated from marine tank vessel loading operations that meet any of the exemptions provided in §63.560(d).  The commenter believes that, in addition to excluding "commodities," other exemptions in §63.560(d) that should be excluded from the annual emission estimation requirement in §63.565(l) include §63.560(d)(2) thru (7).
   The commenter stated EPA could improve the language in §63.565(l) by rewording it as follows:
      (l) Emission estimation procedures. For sources with emissions less than 10 or 25 tons and sources with emissions of 10 or 25 tons, the owner or operator shall calculate an annual estimate of HAP emissions, excluding commodities emissions from marine tank vessel loading operations exempted by §63.560(d), from marine tank vessel loading operations.
      Response  70:  We appreciate the commenter requesting clarification to §63.565(l); however, the commenter's proposed changes to the rule text would not change this paragraph, and the impacts are unknown.  Therefore, we are not adopting the suggested language in this final action.

Other Comments

      Comment  71:  Commenter 297 stated that EPA failed to provide adequate public notice and meetings to the public and Environmental Justice Communities that would be most impacted by this rulemaking.  The commenter noted that EPA provided the minimum public notice required by law, but made no effort to identify EJ advocacy organizations that traditionally participate in EPA rulemakings or those located in US port areas where Marine Tank Vessel Loading Operations are located, noting that most of these groups do not subscribe to the Federal Register.  The commenter stated that EPA could have worked with their Regional Offices to identify EJ advocacy organizations. The commenter requested that EPA conduct public hearings in Environmental Justice Communities that would be most impacted by this new rulemaking, including areas where Ports and Marine Fuel Terminals are located.
      Response  71:  EPA followed the Clean Air Act provisions of section 307(d) in providing public notice of its actions and generally does not provide special notice to any individual parties. These EJ organizations may also use the free website http://www.federalregister.gov/environment to help identify Federal Register notices related to environmental topics that may be of interest.

      Comment  72:  Commenter 265 supports EPA's efforts to conduct the residual risk and technology reviews concurrently, which provides for efficiency, avoids potential inconsistency between standards, and allows for the results of the residual risk assessment to inform the technology review determination.
      Response  72  We agree with the commenter about the benefits of conducting these reviews concurrently, where the statutory residual risk and technology review deadlines make this practicable.


[Federal Register Volume 85, Number 130 (Tuesday, July 7, 2020)]
[Notices]
[Pages 40663-40666]
[FR Doc No: 2020-14516]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5973]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Health Care
Providers' Understanding of Opioid Analgesic Abuse Deterrent
Formulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by August
6, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is ``Health Care Providers' Understanding of
Opioid Analgesic Abuse Deterrent Formulations.'' Also include the FDA
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Health Care Providers' Understanding of Opioid Analgesic Abuse
Deterrent Formulations

OMB Control Number 0910-NEW

I. Background
    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA-regulated products in
carrying out the provisions of the FD&C Act.
    Prescription opioids play a significant role in the opioid misuse
and abuse epidemic in the United States. Opioid analgesics with
properties designed to deter abuse, commonly known as abuse deterrent
formulations (ADFs), may play a role in helping to curb this epidemic.
Currently available ADFs have been demonstrated to deter some forms of
abuse (injection, snorting, or, in some cases, chewing and swallowing).
FDA's own research and other evidence suggests considerable variability
in health care providers' (HCPs) knowledge of and attitudes toward
prescription opioid products and practices (Ref. 1), including
understanding of ADFs. ADF prescription practices may present
opportunities for HCPs to reduce opioid abuse. Conducting a
comprehensive evaluation of opioid prescribers' knowledge, attitudes,
perceptions, experiences, and behaviors related to ADFs will help to
inform FDA's approaches to ADFs.
    Given the significance and far-reaching nature of the opioid
crisis, along with FDA concerns about potential misunderstanding among
HCPs about ADF terminology and capabilities, FDA determined that
systematic research was necessary to provide the detailed and
comprehensive evidence on which to base the Agency's ADF-related
policy, regulatory, and communication decisions, including potential
alternative language that may be necessary to describe and explain
these products. This work aligns with Priority 1 of the FDA's Strategic
Policy Roadmap (https://www.fda.gov/about-fda/reports/healthy-innovation-safer-families-fdas-2018-strategic-policy-roadmap), and the
Department of Health and Human Services (HHS) and the Administration
have similarly placed high priorities on addressing the epidemic of
misuse and abuse of opioid drugs harming U.S. families.
    The study's purpose is to explore and assess the ADF-related
knowledge, attitudes, and behaviors among opioid prescribers
(physicians, nurse practitioners and physician assistants) and
dispensers/pharmacists, including the related terms addiction and abuse
deterrence, and to explore possible alternative language for describing
these products. Phase 1 consisted of focus groups (OMB approval under
control number 0910-0695). The research described in this notice
represents Phases 2 and 3 of the overall project.
    Phase 2 will consist of a survey based on the Phase 1 focus group
findings related to: (1) Health care provider understanding of
addiction, abuse, and abuse deterrent formulations; (2) attitudes
toward, perceptions about, and experiences with abuse-deterrent opioid
analgesics and abuse deterrence, including prescribing decisions and
practices, potential barriers to using ADFs, the quality and
understandability of the ADF nomenclature, and the underlying reasons
for these perceptions; and (3) HCPs' ideas for minimizing confusion
about ADFs, the kinds of ADF training needed, and suggested language/
terms they believe would best convey the concept of abuse deterrence to
HCPs. The objective of the survey will be to determine the prevalence
of HCP knowledge, attitudes, behaviors, and perceptions identified
through the qualitative discussion occurring in the Phase 1 focus
groups and to uncover any subgroup differences among opioid prescribers
and dispensers. We will conduct one pretest, averaging not longer than
20 minutes, to pilot the main survey

procedures among the target HCP populations. The main survey will also
average 20 minutes.
    Phase 3 will build on findings from the Phase 1 focus groups and
Phase 2 survey and will consist of an experimental study examining
variations in descriptive terminology for abuse deterrent formulation
products. We will conduct two pretests, each averaging not longer than
20 minutes, to test the experimental manipulations and pilot the main
study procedures. The main study procedure will also average 20 minutes
in length. Participants will be randomly assigned to read a description
of abuse deterrent formulation opioids that contains one of four terms
that could be used to refer to these products (ADF will function as the
control term) and then complete a questionnaire that assesses their
comprehension and perceptions of the information, including
terminology, as well as their attitudes, behavioral intentions, and
experience related to these types of opioid products.
    For all phases of this research, we will recruit adult health care
professional volunteers 18 years of age or older. We will exclude
individuals who work for HHS or work in the health care, marketing, or
pharmaceutical industries. The sample will consist of 10 percent
pharmacists, at least half of whom dispense ADF opioids. The other 90
percent will be prescribers who, at the time they are recruited, spend
at least 50 percent of their time seeing patients and who have
prescribed opioids to at least five different patients in the last 30
days, with at least half of the opioids they prescribe being for
chronic non-cancer pain. The prescriber sample will be segmented to
include 70 percent primary care providers (i.e., those practicing in
family practice, or internal or general medicine) and 30 percent a mix
of specialists practicing in a variety of fields such as rheumatology,
neurology, anesthesiology, pain management, emergency medicine,
surgery, orthopedics, and physical medicine and rehabilitation. In each
of these groups, 60 to 70 percent will consist of physicians, 15
percent nurse practitioners, and 15 percent physician assistants. A
minimum of 30 percent must have experience prescribing an ADF opioid.
    We will use soft quotas to ensure that our sample includes a
diversity of participants, including related to age, race/ethnicity,
gender, years and location of practice, and opioid prescribing levels.
We will also exclude pretest participants from the main studies, and
participants will not be able to participate in more than one phase of
the project. With the sample sizes described below, we will have
sufficient power to detect primarily small-sized effects for Phases 2
and 3.
    In the Federal Register of February 5, 2020 (85 FR 6562), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received three submissions that were
PRA-related. Within those submissions, FDA received multiple comments,
which the Agency has addressed below.
    (Comment 1) I believe Phase 2 should include more pharmacists than
10 percent ratio.
    (Response 1) We have carefully planned the sample for the study to
ensure sufficient numbers of prescribers, including primary care
providers and several types of specialists (including neurologists,
pain management specialists, rheumatologists, neurologists, surgeons,
orthopedists, physical medicine and rehabilitation specialists),
physician assistants and nurse practitioners, as well as including a
group of pharmacists for analysis. Expanding the sample further is
beyond the scope of what we have planned for the project. Our power
analysis suggests we will have sufficient power to ensure comparisons
between groups in the sample. In addition, in the earlier focus group
phase, pharmacists said they rarely talk with patients about ADFs and
never talk with health care professionals about them, suggesting the
feedback we would receive from them would likely be limited.
    (Comment 2) Practitioners chosen should be based on greater
prescribing habits. Those practitioners who are the larger rate of
treating chronic non-cancer pain with ADF opioid should be the target
of information gathering.
    (Response 2) One of our screening criteria is that at least half of
a provider's prescriptions must be for chronic, non-cancer pain. We
plan to include approximately equal numbers of low, medium, and high
prescribers across each prescriber type and field of practice so that
comparisons can be made between groups. In addition, in the earlier
focus group phase, current prescribers of ADFs were already aware of
and had significant knowledge about ADFs, so their feedback likely
would not provide the kind of insight needed about the misunderstanding
and confusion we previously observed among other prescribers.
    (Comment 3) We support FDA's decision to conduct a comprehensive
evaluation of opioid prescribers' knowledge, attitudes, perceptions,
experiences, and behaviors related to ADFs and agree with the FDA that
new language is needed to better describe and explain ADFs.
    (Response 3) Thank you for this comment.
    (Comment 4) We strongly encourage testing the impact of terminology
that more accurately describes the product's abuse-deterrent
properties. For example, if a pill is formulated to be difficult to
crush, it should be labeled ``crush-resistant.''
    (Response 4) The survey, in part, will provide HCPs an opportunity
to propose terms they think best describe these opioids and will test
both objectively and subjectively numerous alternative terms that were
commonly cited as appropriate by HCP participants in the earlier focus
group phase of this study. This includes terms that relate to physical
manipulation such as ``alteration-resistant opioids'' and ``tamper-
resistant opioids.''
    (Comment 5) We support FDA's efforts to ensure the diversity of the
sample populations for the three proposed studies. It is important to
study health care providers with varying opioid prescribing levels, and
years and locations of practice. We particularly commend the efforts to
additionally account for diverse ages, ethnicities, and gender of the
health care providers, as all of these factors can affect knowledge,
attitudes, and the patients they serve.
    (Response 5) Thank you for this comment.
    (Comment 6) The proposed study plans to include a wide range of
health care providers, including primary care providers; specialists
from various fields such as rheumatology, neurology, anesthesiology,
pain management, emergency medicine, surgery, orthopedics, and physical
medicine and rehabilitation; nurse practitioners; physician assistants;
as well as dispensers/pharmacists. However, there is clear evidence
that dentists, periodontists, and oral surgeons should also be
included, since research has shown that they often overprescribe
opioids.
    (Response 6) While the reviewers raises an important consideration,
the inclusion of dentists and oral surgeons is beyond the scope of the
current study. Dentists do not typically prescribe for long-term pain
and are therefore less likely to prescribe an abuse-deterrent
formulation opioid or ADF, which is the main focus of this study. For a
similar reason, based on what we heard in the earlier focus group phase
of this study, we chose to exclude emergency medicine physicians from
the sample survey populations.
    (Comment 7) The proposed study should explore providers' knowledge
of

how ADF opioids are used and abused once they are on the market.
Opioids considered to be abuse-deterrent are still widely abused
through the most common oral route.
    (Response 7) Our survey questions will include items about provider
knowledge of ADFs, including specific questions to test whether they
are aware that ADFs can still be abused, as well as related to their
experiences with use, misuse, and abuse of opioids.
    (Comment 8) We applaud the effort to gather information about HCPs'
understanding of these products. This effort is consistent with the
Agency's history of extensive and diverse efforts to balance the needs
of people seeking relief from severe acute and chronic pain and the
simultaneous need to avoid worsening of the abuse, addiction, and
diversion of opioid medications in these times of the opioid overdose
epidemic.
    (Response 8) Thank you for this comment.
    (Comment 9) We believe that the proposed sample design adequately
accounts for current ADF product prescribers for chronic non-cancer
pain. It is not clear, however, whether the proposed sample design
would adequately capture the second relevant population, i.e.
appropriate potential prescribers of ADF products for chronic non-
cancer pain. Commenter recommends that FDA focus on those HCPs who
specialize in chronic non-cancer pain management, because these
relatively few HCPs manage a disproportionate volume of patients with
chronic non-cancer pain and, therefore, manage a disproportionate
volume of current and appropriate potential prescriptions of ADF
products for chronic non-cancer pain.
    Suggestions:
     The proposed threshold of 5 patients treated with opioids
for chronic non-cancer pain in a typical month is too low. A low
threshold does not ensure that pain specialists will be included, and
evidence has shown that the treatment of chronic non-cancer pain with
opioids has consolidated under such pain specialists in recent years.
     Study should focus on HCPs who specialize in chronic non-
cancer pain management. This small subset of HCPs manage a
disproportionate volume of patients with chronic non-cancer pain, and
therefore, they manage a disproportionate volume of current and
appropriate potential ADF prescriptions.
     Study can capture both intended populations (current and
``appropriate potential'' prescribers) by recruiting only pain
specialists and imposing a threshold for experience prescribing ADF
products.
    (Response 9) Pain management is one of the specialties included on
our recruitment screener (in addition to rheumatology, neurology,
anesthesiology, surgery, orthopedics, and physical medicine and
rehabilitation). Our screening criteria will ensure an approximately
equal number of low, medium, and high-volume prescribers across each
provider group. We also have included a requirement that at least 50
percent of prescriptions must be for chronic, non-cancer pain. A key
objective of this study is to gain insight into misunderstandings about
ADF opioids and the terminology and how to best address the confusion
and misunderstandings that we found in the earlier focus group phase of
the study as well as in prior research FDA conducted. These data
indicated pain management specialists already tend to have considerable
knowledge about and experience with ADFs, suggesting their feedback
would likely be of limited usefulness with respect to the study's key
objectives. This is similarly the case for ADF prescribers, which is
the reason the study populations were purposely inclusive of a broad
cross-section of opioid prescribers.
    (Comment 10) Include a screening question with a list of ADF
products to account for respondents' lack of knowledge about which
products are and are not ADF.
    (Response 10) Thank you for the suggestion. Our recruitment
screener includes such a question, which asks respondents to identify
which of 17 different listed opioids they have prescribed, including
six abuse-deterrent formulations that will not be identified as such.
The survey questionnaire itself also asks prescribers to specifically
cite in an open-ended question the ADF opioids they have prescribed,
which will be used, in part, to asses ADF knowledge.
    (Comment 11) Set quotas to ensure recruitment of representative
sample sizes for both non-specialists and pain specialists.
    (Response 11) Early in the protocol development we identified the
need for samples of prescribers working in primary care fields and
among those in specific specialties, which research has shown generally
prescribe the most opioids overall, and the sample populations included
in the study will reflect this necessary diversity.
    (Comment 12) Lower Ns for Phase 2 and 3 to ensure timely
completion. In the company's experience, a survey of 200 HCPs takes 5
weeks to complete.
    (Response 12) We identified current sample sizes based on power
calculations. Any reduction in sample size would reduce our power to
find effects. We have planned a timeline for the project to complete
both phases 2 and 3 based experience collecting data using these
methods but will be adjusting as necessary given the COVID-19 pandemic
and any other unforeseen factors. This project is an FDA priority, and
we will prioritize rigorous methodology that ensures representativeness
and robust data and evidence even if it means taking a little more
time.
    (Comment 13) Implement appropriate honoraria to ensure feasibility
and timely results.
    (Response 13) The financial incentive rates were based on going
rates for incentives in provider panel surveys and on recent research
on incentives for physician surveys. These will also comport with those
allowable by OMB. In addition, our experience has shown that the topic
of this study--opioids and the national crisis--and the fact that the
research is being undertaken by FDA, the Federal agency responsible for
regulating these products, are additional incentives for participation.
    FDA estimates the burden of this collection of information as
follows:

                                                    Table 1--Estimated Annual Reporting Burden 1 2 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     Number of  respondents   Number of  responses        Total annual       Average burden  per
              Activity                         \3\               per  respondent           responses               response             Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Phase 2:
    Pretest screener...............  470...................  1.....................  470..................  0.17.................  79.90
                                                                                (10 minutes).........

    Pretest........................  235...................  1.....................  235..................  0.33.................  77.55
                                                                                (20 minutes).........
    Survey screener................  2,120.................  1.....................  2,120................  0.17.................  360.40
                                                                                (10 minutes).........
    Survey.........................  1,060.................  1.....................  1,060................  0.33.................  349.80
                                                                                (20 minutes).........
Phase 3:
    Pretests screener..............  732...................  1.....................  732..................  0.17.................  124.44
                                                                                (10 minutes).........
    Pretests.......................  366...................  1.....................  366..................  0.33.................  120.78
                                                                                (20 minutes).........
    Main study screener............  2,120.................  1.....................  2,120................  0.17.................  360.40
                                                                                (10 minutes).........
    Main study.....................  1,060.................  1.....................  1,060................  0.33.................  349.80
                                                                                (20 minutes).........
                                    --------------------------------------------------------------------------------------------------------------------
        Total......................  ......................  ......................  .....................  .....................  1,823.07
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Includes total burden for project phases 2 and 3.
\3\ Includes 10 percent overage.
\4\ With online surveys, several participants may be in the process of completing the survey at the time that the total target sample is reached. Those
  participants will be allowed to complete the survey, which can result in the number of valid completes exceeding the target number. With this in mind,
  we have included an additional 10 percent over our target number of valid completes to account for some overage.

II. Reference
    The following reference is on display with the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is not
available electronically at https://www.regulations.gov as this
reference is copyright protected.

    1. Hwang, C.S., L.W. Turner, S.P. Kruszewski, et al. ``Primary
Care Physicians' Knowledge and Attitudes Regarding Prescription
Opioid Abuse and Diversion.'' The Clinical Journal of Pain, 32(4),
279-284, 2016.

    Dated: June 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14516 Filed 7-6-20; 8:45 am]
BILLING CODE 4164-01-P