EPA understands that making the Stage II waiver automatic, without the need to revise SIPs, would shorten the time before a state could act to allow GDF owners/operators to decommission their Stage II installations.   However, it is not a possible result under the cooperative federalism approach of the CAA, under which states first adopt control strategies under state law and then submit those for incorporation by EPA into federal law.  States currently have their Stage II programs established in their own legislation and regulations, and EPA does not have the unilateral power to alter state law.  Moreover, where states have submitted their laws to EPA and EPA has approved them into SIPs, the only way to remove those state law provisions from SIPs is for states to later seek such SIP revisions through new submissions, which EPA would then act on under CAA section 110.  In addition, when a state wishes to remove the requirements for Stage II, the CAA requires EPA to ensure that such an action would not interfere with other applicable CAA requirements under section 110(l), which precludes the Administrator from approving a SIP revision if it would interfere with applicable CAA requirements (including attainment and maintenance of the ozone NAAQS).  Some states may find that by removing Stage II requirements they are reducing the overall level of reductions for which they have previously obtained credit. Such states would need to show that foregoing any additional VOC emissions reductions resulting from Stage II would not interfere with attaining and maintaining the ozone NAAQS in violation of section 110(l).  EPA is providing additional guidance to the states to facilitate completion of these analyses, although that guidance is not part of today's final rule.
      Comment:  Commenters (EPA-HQ-OAR-2010-1076-0046, 0049, 0051 and 0052) believed that if Stage II controls are mandated in the OTR for several more years, it will lead to a net emissions increase.  The commenter explained that when an ORVR equipped vehicle is fueled at a Stage II equipped service station, a lack of compatibility between the two controls may actually cause emission reduction of the two systems together to be less than the emission reduction achieved by either system alone.  The commenter contended that by removing Stage II, states would actually be reducing the amount of emissions because a substantial majority of cars on the road will have ORVR and will increase as older vehicles continue to be phased out.  The commenter assumed that if EPA does not revise its section 184(b)(2) guidance for "comparable" measures, states in the OTR will need to achieve additional emissions reductions in order to offset the removal of Stage II.  The commenter encouraged EPA to clearly state that this reduction in emissions from the removal of Stage II can act as an offset for purposes of the comparability analysis.  In other words the vapor emissions that would result if Stage II and ORVR were used in conjunction with one another should be deducted from the total emission reductions states would otherwise need to achieve in implementing another "comparable" emissions reduction policy.  The commenter also recommended that the guidance contain detailed data on the percentage of vehicles on the road projected to have ORVR systems that would be used in the comparability analysis.
      Response:  We acknowledge the points raised by the commenters, although they are not directly relevant to the ORVR widespread use finding and waiver of the section 182(b)(3) requirement that is the subject of this rulemaking.  Part of the purpose for developing the separate section 184(b)(2) guidance released after the publishing of this final rule is to describe these kinds of  concerns and address how they might be handled in future SIPs.
      Comment:  Commenters (EPA-HQ-OAR-2010-1076-0032, 0046, 0049, 0051 and 0052) indicated that in 1995, EPA released a study identifying control measures capable of achieving emission reductions "comparable" to those achievable by Stage II vehicle refueling controls in the OTR.  The commenter pointed out that in the study, EPA interpreted section 184(b)(2) as saying only measures not already prescribed under the CAA can be considered "comparable" measures sufficient to eliminate the Stage II requirement for areas in the OTR.  The commenters concluded that under EPA's interpretation, ORVR controls cannot be considered a "comparable" measure because ORVR systems area already required under section 202(a)(6).  The commenters urged EPA to reconsider this interpretation.  The commenters further alleged that it is not reasonable to interpret the statute as saying a technology designed to replace Stage II is not comparable to Stage II.  The commenters asserted that such an interpretation ignores the plain and contextual meaning of the statute.  The commenters added that by requiring areas in the OTR to implement Stage II or policies that achieve emission reductions "comparable" to Stage II, Congress wanted states to achieve mechanisms not already in place.  The commenters further stated that this is to be distinguished from mechanisms not already prescribed under the statute.  The commenter contended that when the 1995 study was released, ORVR standards were promulgated less than one year earlier.  The commenters indicated that automobile manufacturers generally did not begin installing ORVR on new passenger cars until 1998 when 40 percent of new cars were required to have ORVR.  Since 2000, all new cars have been required to be equipped with ORVR, and all light duty trucks and vans have been so required since 2003.  The commenters concluded that under the CAA, states in the OTR could not point to ORVR to avoid requiring Stage II in 1995 because ORVR was not yet in place, not because ORVR was already prescribed under the statute.  The commenters stated their belief that ORVR was designed to phase out the Stage II requirement, not augment it.
        The commenters pointed out that EPA stated in the July 15, 2011, preamble that when an ORVR vehicle is fueled at a service station equipped with vacuum assist Stage II vapor recovery system, a lack of compatibility between the two controls may actually cause the emission reduction of the two systems together to be less than the emission reduction achieved by either system alone.  The commenters offered a 2007 study published by the Northeast States for Coordinated Air Use Management (NESCAUM), titled "Onboard Refueling Vapor Recovery Systems Analysis of Widespread Use," noted the potential for significant excess emissions throughout the northeast as early as 2012 caused by the incompatibility of the two systems.
      The commenters also offered that beyond the increasing prevalence of ORVR controls, interpreting the word "comparable" in section 184(b)(2) as referring to measures not already prescribed under the CAA disregards EPA's own control efficiency data.  The commenters contended that according to EPA, ORVR-equipped vehicles achieve 98 percent control efficiency, while Stage II alone achieves just 77.4 percent control efficiency.  The commenters indicated their belief that ORVR has infiltrated the market to the point that the EPA no longer believes Stage II will be necessary within two years, largely because ORVR is more successful at reducing emissions than Stage II.  Nonetheless, under EPA's current interpretation of section 184(b)(2), states in the OTR are currently unable to point to ORVR's prevalence as achieving "comparable" emissions reductions.  The commenters believed this is arbitrary and unreasonable.  The commenters further speculated that EPA intends to provide additional guidance for OTR states on how they can conduct updated comparability analyses based on the 1995 study for purposes of removing Stage II under  section 184(b)(2).  The commenters recommended that EPA should revise its interpretation of the word "comparable" in that section.  The commenters asserted that until EPA releases new guidance that clarifies its interpretation of the word "comparable" in section 184(b)(2), they lack sufficient information to provide EPA with informed comments on the Proposal.  The commenters further maintain that if EPA does not revise its outdated interpretation of the word "comparable" in section 184(b)(2), the proposed rule will be of little benefit to refueling facilities located in the OTR.  The commenters offered their belief that cash-strapped states will spend their limited resources on independent comparability analyses and revise their SIPs to eliminate the Stage II requirement.  The commenters conclude that if the EPA updates its interpretation to reflect fifteen years of progress, facilities in the OTR stand to reap substantial benefit.
      Response:  See our earlier responses to similar comments regarding the separate and related, but not directly relevant, CAA section 184(b)(2) issues.  Today's rulemaking takes no final action under section 184(b)(2), but instead only under section 202(a)(6) to find widespread use of ORVR and to exercise our express authority to waive the specific section 182(b)(3) requirement.  The commenter is free to re-raise its section 184(b)(2) concerns in the context of future SIP action implementing that section.  EPA acknowledges the concerns raised by the commenters with regards to comparable measures and the OTR states.  The NPRM discussed this issue by describing the emissions of concern as being those captured by Stage II incremental to ORVR as opposed to all emission reductions from Stage II in the absence of ORVR, as was the case in the mid-1990's.  What has changed is the expected level of emissions reductions that Stage II programs can obtain, in light of the fact that in the OTR areas, Stage II systems (or other comparable measures) were fully implemented more than a decade ago and ORVR is now in force with ORVR-equipped vehicles phasing in at the rate of 3-4 percent of the fleet each calendar year. Thus, the factual circumstances influencing EPA's estimate of what level of emissions reductions are "comparable" to those achieved by Stage II, incremental to ORVR, are different today compared to the mid-1990s. This issue will be further addressed in EPA's guidance which will be issued after publication of this rulemaking, but is not part of the final rule.

     VI. Comments Regarding Decommissioning of Stage Vapor Recovery Systems

      Comment:  Commenter (EPA-HQ-OAR-2010-1076- 0037) insisted that where Stage II equipment is decommissioned, steps must be taken to minimize leaks and fugitive emissions, all of which may result in increased exposure to air toxics or groundwater and soil contamination. NESCAUM urges EPA to provide guidance to ensure that Stage II decommissioning occurs in a manner that minimizes potential for vapor releases from underground piping at facilities that remove their Stage II systems. This guidance should encourage state air offices to coordinate with their state counterparts that manage underground storage tanks to ensure that consistent procedures are in place to address liquid and vapor leak issues associated with decommissioning.
      Commenter (EPA-HQ-OAR-2010-1076-0055) contends that for regions interested in decommissioning Stage II recovery systems, EPA must provide clear implementation guidance describing the CAA provisions that apply depending on an area's circumstances (i.e., Ozone Transport Region [OTR] states, states opting in to Stage II programs, states with Stage II recovery systems prior to 1990 and states with Stage II as a result of the 1990 CAA amendments), since the applicable CAA requirements vary depending on when Stage II was initially implemented or whether a particular area is part of the OTR. Although some states have successfully decommissioned Stage II recovery systems through the SIP revision process, for those areas eligible to decommission Stage II, the commenter believes EPA must still provide the 2 elements minimally needed for a SIP revision, including what is needed for areas subject to CAA section 110(l) and for those subject to section 193. The resulting SIP process should be a streamlined one, consistent with the principles underlying the ongoing NACAA-ECOS-EPA SIP Reform Workgroup.
      Commenter (EPA-HQ-OAR-2010-1076-0043) pointed out that EPA did not provide any guidance on the proper decommissioning or removal of Stage II equipment from facilities.  The commenter expressed concern that Stage II systems be decommissioned properly and requested that EPA provide proper shut down procedures and final inspection criteria to certify a proper shut down.
      Commenter (EPA-HQ-OAR-2010-1076-0042) requested that EPA provide further information on the overall expectations and steps needed for states to be granted a waiver and properly retire a Stage II program.  The commenter stated that the guidance should include the following: 1) a listing of specific steps necessary for gasoline dispensing facilities to decommission their existing Stage II equipment, 2) a description of the State's role in the decommissioning procedure and outline any required follow-up with the affected GDFs.
      Commenter (EPA-HQ-OAR-2010-1076-0048) requested that EPA should be clear in the final rule that the process for physically decommissioning the Stage II equipment should be left to the individual states and regions and not dictated in a rule or guidance document by EPA.
      Response:  EPA understands the request for clear guidelines for decommissioning Stage II systems safely and effectively.  EPA has often referenced that industry association codes and standards be followed (where applicable) to ensure that Stage II systems are properly designed, constructed, installed, and, in this case, dismantled or decommissioned. Industry codes and standards provide a means for improving methods or developing alternative methods of Stage II system decommissioning and we encourage States and local agencies to reference these codes.  EPA realizes that industry codes and standards may be updated periodically and EPA also recognizes that State and local requirements may supersede industry codes and standards or be inherently more stringent.  EPA regulations do not require the use of a particular issue of any code. EPA encourages owners/operators to use the version of the code or standard that is current at the time the Stage II decommissioning activity occurs.  The Petroleum Equipment Institute (PEI) and at least four states have recommended practices or specific requirements for decommissioning Stage II systems.  The PEI guidance, "Recommended Practices for Installation and Testing of Vapor Recovery Systems at Vehicle Fueling Sites, PEI/RP300-09," is especially instructive as it was developed by industry experts with a focus on regulatory compliance and safety.  It basically contains the steps which involve dismantling Stage II hardware and applies to both balance and vacuum assist type systems.  Please be aware that there may be other codes or standards not listed here that may be used to ensure proper Stage II decommissioning.
      Comment:  Commenter (EPA-HQ-OAR-2010-1076-0060) described themselves as a company that has valid emissions monitoring data from sites where Stage II vapor return has been disconnected.  The commenter supplied data that showed the effectiveness of conducting continuous pressure monitoring inside storage tanks at locations where Stage II vapor recovery has been removed.
      Response:  EPA is encouraged that continuous pressure monitoring inside storage tanks can be very effective in monitoring the liquid and vapor containment integrity of the system.  EPA encourages the commenter to make available their technology to the states to consider in SIP actions and for the GDF operators to follow federal, state and local requirements for tank integrity testing. We did not propose nor at this point are we considering any mandatory integrity testing beyond that contained in 40 CFR part 63 subpart CCCCCC.

     VII. Comments Regarding EPA's Proposed Estimated Cost Savings

      Comment:  Commenters (EPA-HQ-OAR-2010-1076-0046, 0049, 0050, 0051 and 0052), estimated the cost for purchase and installation of new Stage II equipment to be $50,000 per retail site, exclusive of annual maintenance costs.  The commenters further stated that overall escalating costs at retail locations is increasingly burdensome for small business petroleum marketers and largely unnecessary given what the commenters believed is current attainment of widespread use of ORVR nationwide.  In regards to the Stage II waiver, the commenters stated that the waiver should be self-effective on June 30, 2013, when nationwide widespread use is set to occur, rather than conditioned on the lengthy process involving the preparation, submission and approval of a SIP for the NAAQS. The commenters added that this action would be far more likely to achieve the Administration's regulatory and cost-savings objectives, rather than requiring states with strained resources to develop and submit a SIP revision.
      Response:  EPA thanks the commenters for providing support for the waiver of CAA Section 182(b)(3) Stage II vapor recovery requirements.  EPA also recognized a cost savings in the decommissioning of Stage II vapor recovery systems and we share the commenter's interest in a quick and orderly decommissioning of Stage II installations and avoidance of installations at new GDFs where they may be in place for a very short time assuming such actions meet state requirements.
      EPA understands that making the Stage II waiver automatic, without the need to revise SIPs would shorten the time before a state could act to allow GDF owners/operators to decommission their Stage II installations.  However, as previously explained, such an approach is not possible under the cooperative federalism scheme of the CAA, which depends upon state adoption and submission of proposed SIP revisions before EPA can revise any SIP that currently requires Stage II under state law.  Moreover, when a state wishes to remove from its EPA-approved SIP its own state law requirements for Stage II, the CAA requires EPA to ensure that such an action would not interfere with other applicable CAA requirements under section 110(l), which precludes the Administrator from approving a SIP revision if it would interfere with applicable CAA requirements (including attainment and maintenance of the ozone NAAQS).
      Of course, even after EPA takes final action to find widespread use of ORVR has occurred and issues a waiver of the section 182(b)(3) requirement, states remain free under CAA section 116 to choose to implement Stage II programs in any area, and would not be forced to remove existing Stage II provisions from a SIP.  States may choose to continue to require or enhance Stage II controls in a particular area or areas assuming they continue to achieve air quality benefits.
        Comment:  Commenter (EPA-HQ-OAR-2010-1076-0036) believed that EPA's rule changes did not address the incompatibility of ORVR and State II vapor recovery systems. The commenter stated that EPA failed to highlight the unique differences between the two types of State II vapor recovery systems, the balanced system and the assisted systems. The commenter offered inherent advantages in the balance system and stated that EPA proposal neglected to implement programs that can lower a station's operating costs and save substantial quantities of gasoline by preventing air pollution. The commenter contends that funds would be better spent converting existing Stage II assist and balance sites into enhanced vapor recovery (EVR) systems. The commenter claimed EVR systems would save over 66 million gallons of gasoline between mid-2013 and the end of 2020.
      Response:  In the proposed rule, EPA believes it addressed the incompatibility of ORVR and Stage II vapor recovery systems by indicating that when an ORVR vehicle is fueled at a GDF equipped with a vacuum assist Stage II vapor recovery, a lack of compatibility between the two controls may actually cause the emission reduction of the two systems together to be less than the emission reduction achieved by either system alone.  This issue was discussed in the NPRM and documents related to this issue were placed in the docket at that time. A guidance document related to this issue, to help states address this issue in future SIP actions, will be released subsequent to this final rule. EPA proposed a waiver of the requirements of section 182(b)(3) and did not propose a waiver of a certain type of Stage II vapor recovery technology in favor of another Stage II technology.  In fact the section 182(b)(3) requirement does not specify which type of Stage II hardware should be used.  This specification was left to the affected states. EPA is taking final action to find widespread use of ORVR has occurred and has issued a waiver of the section 182(b)(3) requirement.  The waiver of the section 182(b)(3) requirement does not depend upon whether an area has chosen to use a balance system or a vacuum assist system.  States remain free under CAA section 116 to choose to implement Stage II programs in any area, and would not be forced to remove existing Stage II provisions from a SIP.  Those States may implement any particular type of technology they may choose.  In the draft Regulatory Support Document, EPA's intent was to associate national cost savings with the decommissioning and removal of Stage II equipment. However, EPA has not prohibited any area that maintains its Stage II requirements from allowing investment into enhanced Stage II systems or any other system which enhances emission controls at GDFs.
      Comment:  Commenters (EPA-HQ-OAR-2010-1076-0046, 0049, 0051, and 0052) welcomed EPA's desire to eliminate Stage II vapor recovery requirements. NACS has urged EPA move in this direction for many years. However, the commenters articulated that if the Proposed Rule were finalized as written, it would achieve only 41 percent of the Administration's desired savings, leaving over $52,000,000 of the projected annual savings unrealized.  The commenters indicated that 15,937 retail fuel outlets are within the OTR.  The commenters asserted that this is approximately 59 percent of the total number of dispensing facilities (outside California) that are required to have Stage II vapor recovery systems. The commenters claimed that based on EPA's estimated cost savings, affected stations would save approximately $3,277 annually if Stage II requirements were eliminated.  The commenters determined that the total dollars saved by eliminating Stage II in the OTR would be approximately $52,225,000. The commenters concluded that according to EPA's estimate for the total savings achieved by the Proposal ($88 million), nearly 60 percent of such savings would be lost if areas in the OTR are still required to mandate Stage II controls.
      Response:  EPA's analysis indicates that there are about 17,000 public, government, and private GDFs in the OTR with Stage II. This count varies almost daily as current GDFs close and new ones are opened.  This final rule will allow states with Serious and above ozone nonattainment areas that are now required by CAA section 182(b)(3) to have Stage II gasoline vapor recovery equipment on these GDFs to be relieved of this requirement after the waiver date.  States in the Ozone Transport Region (OTR) may already choose, in lieu of Stage II requirements in areas that are cleaner than Serious ozone nonattainment, to adopt measures to achieve emissions reductions that are comparable to those achievable by Stage II.  After the Stage II waiver is effective, Serious and above ozone nonattainment areas in the OTR would also be able to make this choice.  Separate from this rulemaking, EPA will develop additional updated guidance for OTR states on determining "comparability" of emissions reductions in light of continuing growth of the vehicle fleet equipped with ORVR.  We believe this guidance will facilitate state analysis regarding comparable reductions if they choose to both act on the Stage II waiver to revise their section 182(b)(3) SIPs and to revise their section 184(b)(2) SIPs. EPA's estimate of potential cost savings was based on the assumption that states in the OTR currently subject to the section 182(b)(3) requirement would be able to remove Stage II and adopt comparable measures as needed, and we still believe this is a valid view.  Indeed such actions are now underway to varying degrees in Maine, Vermont, and New Hampshire.


[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Notices]
[Pages 7390-7391]
[FR Doc No: 2019-03807]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1067]

Evaluation of Bulk Drug Substances Nominated for Use in
Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic
Act; 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 the Agency) is
announcing the availability of a final guidance for industry entitled
``Evaluation of Bulk Drug Substances Nominated for Use in Compounding
Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This
guidance describes policies that FDA intends to use in evaluating bulk
drug substances nominated for use in compounding under section 503B of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) for inclusion on
the list of bulk drug substances that can be used in compounding under
section 503B.

DATES: The announcement of the guidance is published in the Federal
Register on March 4, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2018-D-1067 for ``Evaluation of Bulk Drug Substances Nominated for
Use in Compounding Under Section 503B of the Federal Food, Drug, and
Cosmetic Act.'' 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.gpo.gov/fdsys/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 guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-
3110.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Evaluation of Bulk Drug Substances Nominated for Use in
Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic
Act.'' Section 503B (21 U.S.C. 353b), added to the FD&C Act by the Drug
Quality and Security Act in 2013, describes the conditions that must be
satisfied for human drug products compounded by an outsourcing facility
to be exempt from the following three sections of the FD&C Act: section
505 (21 U.S.C. 355) (concerning the approval of drugs under new drug
applications or abbreviated new drug applications); section 502(f)(1)
(21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate
directions for use); and section 582 (21 U.S.C. 360eee-1) (concerning
drug supply chain security requirements). One of the conditions that
must be met for a drug product compounded by an outsourcing facility to
qualify for these exemptions is that the outsourcing facility does not
compound drug products using a bulk drug substance unless either: (1)
It appears on a list established by the Secretary of Health and Human
Services identifying bulk drug substances for which there is a clinical
need (see section 503B(a)(2)(A)(i) of the FD&C Act) (503B Bulks List)
or (2) the drug compounded from such bulk drug substances appears on
the drug shortage list in effect under section 506E of the FD&C Act (21
U.S.C. 356e) at the time of compounding, distribution, and dispensing
(see section 503B(a)(2)(A)(ii) of the FD&C Act).
    This guidance addresses FDA policies for developing the 503B Bulks
List, including the Agency's interpretation of the phrase ``bulk drug
substances for which there is a clinical need,'' as it is used in
section 503B of the FD&C Act. The guidance also addresses the factors
and processes by which the Agency intends to evaluate and list bulk
drug substances.
    In the Federal Register of March 26, 2018 (83 FR 12952), FDA issued
a notice announcing the availability of the draft version of this
guidance. The comment period ended on May 25, 2018. FDA received
approximately 60 comments on the draft guidance. In response to
received comments or on its own initiative, FDA made certain changes to
the guidance. For example, FDA has further explained how Congress'
limitation on bulk drug substances that can be used in compounding
under section 503B helps to preserve the integrity of the new drug
approval process and identified the process to request that FDA add or
remove a bulk drug substance from the 503B Bulks List after the Agency
has made a final determination with respect to that substance in the
Federal Register.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). This guidance represents the
current thinking of FDA on ``Evaluation of Bulk Drug Substances
Nominated for Use in Compounding Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.'' 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. This guidance is not subject to Executive
Order 12866.

II. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: February 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03807 Filed 3-1-19; 8:45 am]
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[Federal Register: June 22, 2010 (Volume 75, Number 119)]
[Notices]
[Page 35512]
[DOCID:fr22jn10-80]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, June
24, 2010 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Paredes, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting scheduled for Thursday,
June 24, 2010 will be:

Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Adjudicatory matters; and
Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: June 17, 2010.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010-15147 Filed 6-18-10; 11:15 am]
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