[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Proposed Rules]
[Pages 22428-22436]
[FR Doc No: 2018-10321]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 3

[Docket No. FDA-2004-N-0191]

Product Jurisdiction

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing
to amend its regulations concerning the classification of products as
biological products, devices, drugs, or combination products, and their
assignment to Agency components for premarket review and regulation.
This proposed rule would update the regulations to clarify the scope of
the regulations, streamline and clarify the appeals process, align the
regulations with more recent legislative and regulatory measures,
update advisory content, and otherwise clarify the regulations,
including updates to reflect Agency practices and policies. These
changes are intended to enhance regulatory clarity and efficiency.

DATES: Submit either electronic or written comments on the proposed
rule by July 16, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 16, 2018. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management

Staff, FDA will post your comment, as well as any attachments, except
for information submitted, marked and identified, as confidential, if
submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2004-N-0191 for ``Product Jurisdiction.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov, or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     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.

FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Associate Director
for Policy, Office of Combination Products, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver
Spring, MD 20933,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary
I. Description of the Proposed Rule
    A. Clarify the Scope of the Regulation
    B. Streamline and Clarify the Appeals Process for Product
Classifications and Assignments
    C. Aligning Part 3 with More Recent Legislative and Regulatory
Measures
    D. Update Advisory Content
    E. Other Clarifications to the Rule
II. Legal Authority
III. Paperwork Reduction Act of 1995
IV. Analysis of Environmental Impact
V. Federalism
VI. Consultation and Coordination with Indian Tribal Governments
VII. Preliminary Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
VIII. Proposed Effective Date
IX. Reference

Executive Summary

    FDA promulgated its product jurisdiction regulations, codified at
part 3 (21 CFR part 3), in 1991 (see 56 FR 58754, November 21, 1991).
Although FDA amended these regulations most recently in 2005, to
clarify the meaning of the statutory term ``primary mode of action''
for assignment of combination products to Agency components (see 70 FR
49848, August 25, 2005), the regulations remain largely as published in
1991. However, relevant statutory provisions have changed; FDA has
published additional policies so that the advisory content included in
the regulations requires updating; and in other respects the rule
warrants revisions to enhance clarity and efficiency. Accordingly, FDA
is proposing to amend part 3 to: (1) Clarify the scope of the
regulations; (2) streamline and clarify the appeals process; (3) align
the regulations with more recent legislative and regulatory measures;
(4) update advisory content; and (5) otherwise clarify the rule,
including updating it to reflect Agency policies and practices.
    The incremental quantified cost savings of the proposed rule accrue
to both the Agency and industry from resources, such as time and paper,
saved through eliminating the part 3 appeal to the Office of
Combination Products (OCP). These annual social cost savings are
estimated to be $28,000. Sponsors are expected to incur one-time costs
to read and understand the regulation. Our primary estimate of the
total cost to industry in the first year is approximately $131,000.
    The Agency estimates the quantifiable net social effect of the
proposed rule to be a cost of approximately $103,000 in the first year
and a cost savings of approximately $28,000 each year starting in the
second year. The net present discounted value of the quantifiable net
effect over 10 years is approximately $114,000 at a 3 percent discount
rate and $76,000 at a 7 percent discount rate. The total annualized net
effect of the proposed rule is estimated to produce an average net cost
savings ranging from $13,000 at a 3 percent discount rate and $11,000
at a 7 percent discount rate.

I. Description of the Proposed Rule

    For the reasons presented in the following subsections, FDA
proposes to amend its regulations on Product Jurisdiction codified at
part 3 to: (1) Clarify the scope of the regulation; (2) streamline and
clarify the appeals process; (3) align the regulations with more recent
legislative and regulatory measures; (4) update advisory content; and
(5) otherwise clarify the rule, including updating it to reflect Agency
policies and practices.

A. Clarify the Scope of the Regulation

    This proposed rule, if finalized, would amend Sec.  3.3--Scope, to
clarify that the part 3 procedures apply to sponsors (also referred to
as applicants, see Sec.  3.2--Definitions) for products for which the
classification as biological products, devices, drugs, or combination
products, or the Agency component with primary jurisdiction, is unclear
or in dispute. It would also make conforming revisions to other
sections in part 3, including the definitions in Sec.  3.2.
    FDA published its product jurisdiction regulations codified at part
3 in 1991, in part to implement section 503(g) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353(g)), which calls upon
the Agency to assign products that are comprised of any combination of
a drug and a device, a device and a biological product, a biological
product and a drug, or a drug, a device and a biological product
(``combination products'') to Agency components based on the primary
mode of action (PMOA) of the combination product. The rulemaking also
established that the same procedures would be used to assign biological
products, devices, and drugs to Agency components when their assignment
was unclear or in dispute.
    Although part 3 did not expressly refer to classification of
products as biological products, devices, drugs, or combination
products, such

determinations are generally necessary to make an assignment
determination. Non-combination products (biological products, devices,
and drugs) are assigned to Agency components based on their
classification. Accordingly, the Agency needs to determine, for
example, whether a product is a biological product to be able to
determine whether it should be assigned to a component that regulates
biological products. Similarly, assignment of combination products is
based on determining whether the product is a combination product and
if so, which constituent part of the combination product (biological
product, device, or drug) provides the PMOA (or applying the algorithm
specified in Sec.  3.4(b) if the PMOA cannot be determined with
reasonable certainty).
    Therefore, the Agency has been accepting under part 3 sponsor
requests for the Agency to make product classification as well as
assignment determinations (see, e.g., ``How to Write a Request for
Designation (RFD)'', at https://www.fda.gov/regulatoryinformation/guidances/ucm126053.htm). FDA's longstanding acceptance and review of
sponsors' requests for product classification under part 3 is
consistent with the obligations to which FDA became subject in 1998
under section 416 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115), which added section 563 to the FD&C
Act (21 U.S.C. 360bbb-2). Section 563 of the FD&C Act requires FDA to
classify products as biological products, devices, drugs, or
combination products and to assign products to an Agency component for
regulation, in response to requests for designations submitted by
product sponsors. The procedures at part 3 are appropriate for
implementation of section 563 as well as section 503(g) of the FD&C
Act, and FDA has used these procedures for both purposes to date.
    This proposed rule would revise Sec.  3.3 to clarify that FDA's
procedures in part 3 apply to classification of products as biological
products, devices, drugs, or combination products as well as to
assignment of these products to Agency components, and would make
corresponding amendments to other sections in part 3, including
Sec. Sec.  3.1, 3.7(c)(3) (see proposed 3.5(b)), 3.8(b) (see proposed
3.6(b)), 3.9(b) (see proposed 3.7(b)), and the definitions in Sec.  3.2
for ``letter of designation,'' ``letter of request,'' and ``product
jurisdiction officer,'' to be consistent with this clarified statement
of scope.
    In addition, Agency experience over the 26 years since part 3 was
codified has shown that sponsors sometimes are confused as to whether
they must request a classification or assignment determination under
part 3 as a prerequisite to making a premarket submission for their
product, regardless of whether the classification or assignment for
their product is unclear or in dispute. In addition, some entities who
are not the sponsor for the product have attempted to obtain a product
classification or assignment determination. To eliminate this
confusion, this proposed rule would also revise Sec.  3.3 to state that
the part 3 procedures apply to sponsors if classification or assignment
is unclear or in dispute for their product. If no such uncertainty
exists, use of the procedures is unnecessary, and sponsors can engage
directly with the appropriate Agency component. Further, clarifying
that part 3 applies to sponsors is consistent with section 503(g) of
the FD&C Act, as amended by the 21st Century Cures Act (Cures Act)
(Pub. L. 114-255), and with section 563 of the FD&C Act.

B. Streamline and Clarify the Appeals Process for Product
Classifications and Assignments

    Section 3.8(c)--Requests for reconsideration. The proposed rule
would remove, as confusing and inefficient, the process codified at
Sec.  3.8(c) for sponsors to request that the product jurisdiction
officer reconsider determinations made under part 3.
    Currently, a sponsor may make a request for reconsideration and if
the sponsor disagrees with the decision upon reconsideration, the
sponsor may make an additional, supervisory appeal in accordance with
Sec.  10.75 (21 CFR 10.75). Alternatively, the sponsor may directly
submit such a supervisory appeal without first requesting
reconsideration under Sec.  3.8(c).
    This current approach has proven confusing to sponsors and
inefficient for sponsors and Agency staff. Determinations under part 3
are made through a robust process involving OCP's review of
information, either provided by the sponsor or otherwise available to
the Agency, in consultation with regulatory, legal, and scientific
staff from other Agency components, as appropriate. Consistent with
appeals under Sec.  10.75, no new information may be presented in a
request for reconsideration under Sec.  3.8(c). Because determinations
under part 3 are made through a robust process, further evaluation of
the same data and information by OCP is unlikely to result in a change
of decision. Requests for reconsideration have been inefficient for
sponsors who have opted to utilize this mechanism, and inclusion of the
request for reconsideration mechanism has led to confusion, with
sponsors sometimes believing they must make a request for
reconsideration before they may submit a Sec.  10.75 supervisory
appeal.
    Accordingly, FDA has determined that the request for
reconsideration process is unhelpful to retain.

C. Aligning Part 3 With More Recent Legislative and Regulatory Measures

    In addition to the amendments made by section 416 of FDAMA
regarding classification and assignment discussed in section I.A, two
other statutory changes have been made relating to issues addressed in
part 3 since FDA promulgated the part 3 regulations in 1991, and this
rule proposes to amend part 3 to comport with these statutory changes
as well.
    FDA amended part 3 in 2005 to clarify the meaning of PMOA for
assignment of combination products, and to codify at Sec.  3.2
definitions for biological product, device, and drug ``modes of
action'' based upon the statutory definitions of biological product,
device, and drug. The Biologics Price Competition and Innovation Act of
2009 (Subtitle A of Title VII of the Patient Protection and Affordable
Care Act (Pub. L. 111-148)) amended the definition for biological
product at section 351(i) of the Public Health Service Act (PHS Act)
(42 U.S.C. 262(i)) to address expressly and more precisely the
classification of proteins as biological products. This proposed rule
would amend the definition for ``biological product mode of action'' at
Sec.  3.2 to align with the current statutory definition for biological
product.
    In 2016, section 3038 of the Cures Act amended section 503(g) of
the FD&C Act, to include additional provisions relating to intercenter
consultation and coordination (see 21 U.S.C. 353(g)(8)(C)), reinforcing
expectations that intercenter consultation and coordination occur as
appropriate. Currently, Sec.  3.4(c) states in part that the
designation of a center (an ``agency component'' as defined in Sec.
3.2) as having primary jurisdiction for a combination product does not
preclude consultations by that component with other components. In
keeping with section 503(g) of the FD&C Act as amended and Agency
practice, the Agency is revising Sec.  3.4(c) to make clear that
consultations with other Agency components will occur as FDA deems
appropriate. Agency practice is to conduct intercenter consultation and
coordination routinely to ensure appropriate expertise is brought to
bear

to enable fully informed reviews and consistent regulation of products.
    In addition, section 503(g) of the FD&C Act, as amended by section
3038 of the Cures Act, states that combination products shall be
reviewed under a single application whenever appropriate, and that
sponsors may submit separate applications for the constituent parts of
a combination product unless FDA determines a single application is
necessary (see 21 U.S.C. 353(g)(1)(B) and (6)). Currently, Sec.  3.4(c)
states in part that the Agency can require in appropriate cases that
constituent parts of a combination product be reviewed under separate
applications. Accordingly, to avoid confusion that might arise from
maintaining this different articulation of Agency authority on this
topic, the proposed rule would remove this language at Sec.  3.4(c).
FDA intends to issue guidance regarding implementation of the new
statutory provisions as needed given Agency experience with
implementing them.\1\
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    \1\ Section 3038 of the Cures Act also amended section 503(g) of
the FD&C Act in other respects relating to combination product
assignment, including to: Incorporate a definition for PMOA, which
is consistent with the regulatory definition of PMOA at Sec.  3.2,
promulgated by FDA in its 2005 amendments to part 3 (see 21 U.S.C.
353(g)(1)(C)); provide that drug or biological product PMOA cannot
be based solely upon the product having any chemical action within
or on the human body (see 21 U.S.C. 353(g)(1)(E)); provide that
sponsors who disagree with FDA's PMOA determination may request a
substantive rationale of the determination (see 21 U.S.C.
353(g)(1)(F)(i)); and provide a mechanism for sponsors and FDA to
collaborate and seek agreement on studies to establish the relevance
of the chemical action in achieving the PMOA of their products if
they do not agree with the Agency's PMOA determination (see 21
U.S.C. 353(g)(1)(F)(ii)). These amendments serve to codify
longstanding Agency regulatory interpretations and practices.
Accordingly, FDA has determined that revision of part 3 with respect
to these statutory amendments is not necessary.
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    The rule uses the term ``application,'' and lists types of
applications within the definition for ``premarket review'' at Sec.
3.2. However, the types of premarket submissions for medical products
have changed since publication of part 3, and this listing is now
incomplete. To enhance clarity and completeness, the proposed rule
would add a current, complete definition for ``application,'' and
remove the existing, related language currently included in the
definition for ``premarket review'' in Sec.  3.2. In addition, for
clarity and alignment with Agency practice, the proposed rule would
revise Sec.  3.2 to define premarket review to include examination of
data and information ``submitted by an applicant,'' rather than ``in an
application,'' since premarket review can include Agency review of
information provided as part of ``pre-submission'' engagement with
applicants.
    In addition, the proposed rule would amend Sec.  3.2--Definitions
to include a cross-reference to the definition for ``constituent
part,'' codified at 21 CFR 4.2 in the 2013 rulemaking regarding current
good manufacturing practices for combination products, and which has
also been referenced at 21 CFR 4.101 as part of the 2016 rule on
postmarketing safety reporting for combination products (81 FR 92603).
The meaning of the term is the same for purposes of part 3 as for
purposes of part 4. Accordingly, cross-referencing the definition into
part 3 would serve to ensure clarity and consistency.

D. Update Advisory Content

    Part 3 includes advisory language and addresses associated with
Agency guidance in various locations. As a general matter,
recommendations from FDA are provided in guidance documents published
in accordance with good guidance practices (see 21 CFR 10.115). This
approach not only enables the public to comment on proposed guidance,
but also enables FDA to update guidance in a timely manner given
stakeholder and Agency experience with the policy topic. FDA included
advisory content in part 3 in light of the novelty of the regulatory
topic at the time, to facilitate stakeholder understanding and indicate
Agency thinking. However, Agency thinking has evolved since
promulgation of part 3 and more complete, current guidance documents
and other policy statements are now available. Accordingly, the
proposed rule, if finalized, would remove the advisory content and
discussion of guidance from part 3. Specifically, this proposed rule
would remove the provisions at Sec. Sec.  3.2, 3.5, and 3.7, as
explained below.
    Section 3.2 includes in the definition for ``mode of action'' a
reference to constituent parts of combination products each providing
one type of mode of action and notes that the mode of action of each
constituent part is typically identifiable. The proposed rule would
replace this potentially confusing language, with a simple statement
that each constituent part contributes one mode of action (device,
drug, or biological product). Modes of action of a combination product
and how to address them in requests for assignment are more fully
addressed in Agency guidance, including in ``How to Write a Request for
Designation (RFD).''
    Section 3.5 addresses the relationship between part 3 and
intercenter agreements on product assignment. The proposed rule would
remove this section. These non-binding intercenter agreements adopted
in 1991 address the assignment of biological products, devices, and
drugs, as well as combination products. The Medical Device User Fee and
Modernization Act (MDUFMA) (Pub. L. 107-250) enacted in 2002 amended
section 503(g) of the FD&C Act to require FDA to review each agreement,
guidance, or practice addressing the assignment of combination products
to Agency centers, for consistency with section 503(g) (see 21 U.S.C.
353(g)(8)(F)). In accordance with this mandate, FDA conducted a review,
including of the intercenter agreements addressed in Sec.  3.5, and
published its assessment in 2006 (see ``Jurisdictional Update:
Intercenter Agreements'', at https://www.fda.gov/CombinationProducts/JurisdictionalInformation/JurisdictionalUpdates/ucm106506.htm). The
Agency concluded that: (1) The usefulness of these agreements was
becoming increasingly limited; (2) that they should not be relied upon
independently as the most current, accurate jurisdictional statements;
and (3) that issuance of new guidance and other efforts should be
pursued to enhance transparency and more clearly articulate the
principles upon which jurisdictional determinations are based.
Consistent with that assessment, FDA has since published various policy
statements relating to product classification and assignment and posted
various other relevant materials on its website (see https://www.fda.gov/CombinationProducts/default.htm), most recently, a final
guidance on ``Classification of Products as Drugs and Devices and
Additional Product Classification Issues'' (September 2017) (https://www.fda.gov/RegulatoryInformation/Guidances/ucm258946.htm). The Agency
is currently reviewing these intercenter agreements to determine what
action, if any, to take with respect to them.
    Sections 3.7(a) and (b) include recommendations regarding who
should file an RFD and when they should file them, respectively. The
proposed rule, if finalized, would remove these provisions. These
questions are addressed by the proposed amendments to Sec.  3.3
discussed in section I.A, and current Agency guidance, including in
``How to Write a Request for Designation (RFD)'', which provides more
clear and complete recommendations regarding timing and other process
considerations.

E. Other Clarifications to the Rule

    Section 3.2 defines mode of action, and what constitutes a
biological product, device, and drug mode of action, for purposes of
making combination product assignment determinations. To enhance
clarity, the proposed rule would add an express statement that the mode
of action definitions apply for purposes of making combination product
assignment determinations, and would simplify the definition for device
mode of action at Sec.  3.2 by referring to the statutory definition of
device provided in section 201(h) of the FD&C Act (21 U.S.C. 321(h))
and removing redundant language.
    Section 3.4(a)--Designated Agency component. The proposed rule
would amend Sec.  3.4(a) to clarify that the Agency component to which
a combination product is assigned based on PMOA is the component that
regulates the constituent part providing the PMOA. For example, some
biological products are assigned to the Center for Biologics Evaluation
and Research (CBER) and others are assigned to the Center for Drug
Evaluation and Research (CDER). If a combination product has a
biological product PMOA, it is assigned to either CBER or CDER based
upon which of these two Centers regulate that type of biological
product. This interpretation of the statutory provisions governing PMOA
and combination product assignments is consistent with Agency practice
and ensures that combination products are assigned to the Agency
component most familiar with the constituent part that provides the
PMOA.
    Sections 3.2 and 3.6--Product jurisdiction officer. Section 3.2
includes a definition of ``product jurisdiction officer'' and section
3.6 specifies that OCP is the designated product jurisdiction officer.
The proposed rule would revise the definition for ``product
jurisdiction officer'' at Sec.  3.2 to include information currently
provided in Sec.  3.6, and remove Sec.  3.6, simplifying the rule by
consolidating this related information. Specifically, the definition of
``product jurisdiction officer'' at Sec.  3.2 would be revised to refer
to OCP as the office responsible for classification and assignment of
medical products. MDUFMA required FDA to establish an office to perform
various regulatory functions relating to combination products,
including their assignment to Agency components. Consistent with that
mandate, FDA created OCP and delegated to specified staff within OCP
the authority to classify products as biological products, devices,
drugs, or combination products as well as to assign these products to
an Agency component with primary jurisdiction for their premarket
review and regulation.
    Existing section 3.7(d) addresses where to file RFD communications
and currently requires submission in hard copy with the option to
submit electronically as well. FDA sees no reason to continue to
require a hard copy submission and proposes to revise the provision
(see proposed Sec.  3.5(b)) and make corresponding revisions to the
content of Sec.  3.7(c) (see proposed 3.5(b)) to give sponsors the
alternative of submitting solely electronically. In addition, to avoid
the need to revise the rule given changes to OCP's mailing address or
email address, this rule would amend Sec.  3.7(d) (see proposed 3.5(b))
to direct sponsors to submit RFDs to the current mailing address or
email address for OCP as published by FDA, currently on the Office of
Combination Products web page (https://www.fda.gov/CombinationProducts/default.htm).
    Section 3.9(b) addresses grounds for changing a classification or
assignment designation, including circumstances under which the Agency
can do so without the consent of the sponsor. It currently provides
that sponsors shall be given 30 days written notice (which can be via
email) of proposed changes and that such changes require the
concurrence of the Principal Associate Commissioner. Because positions
and titles in the Agency change from time to time, to avoid the need to
revise part 3 when such changes occur, this rule would revise Sec.
3.9(b) (see proposed Sec.  3.7(b)) to state that such changes of
classification or assignment require the concurrence of the official in
the Agency responsible for the oversight of OCP.
    Other clarifying changes to part 3 include in Sec.  3.2: In the
definitions of ``combination product'' and ``product,'' changing
``biologic'' to ``biological product'' to provide for consistency in
part 3 and with the term used in section 351 of the PHS Act; and in the
definitions of ``biological product'' and ``product,'' changing
``351(a)'' to ``351(i)'' and ``262(a)'' to ``262(i)'' so that the
correct provision in the PHS Act and the U.S. Code is cited (i.e., the
provision that defines ``biological product'').

II. Legal Authority

    The Agency derives its authority to issue the regulations found in
part 3 from 21 U.S.C. 321, 351, 352, 353, 355, 360, 360c-360f, 360h-
360j, 360gg-360ss, 360bbb-2, 371(a), 379e, 381, 394; 42 U.S.C. 216,
262, and 264. Congress expressly directed FDA to assign combination
products to the appropriate Agency component for regulation based on
the Agency's assessment of PMOA as set forth in section 503(g) of the
FD&C Act. Congress also expressly directed FDA to determine the
classification of a product as a drug, biological product, device, or
combination product, or the component of the Agency that will regulate
the product, as applicable, in response to a request submitted under
section 563 of the FD&C Act. Under section 701 of the FD&C Act (21
U.S.C. 371) and for the efficient enforcement of the FD&C Act, FDA has
the authority to issue and amend the regulations found in part 3.

III. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no new
collection of information. Therefore, clearance by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
is not required. Information collection under part 3 has already been
approved under OMB control number 0910-0523.

IV. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

V. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.

VI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the rule does not contain policies that would have a
substantial direct effect on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on

the distribution of power and responsibilities between the Federal
Government and Indian Tribes. The Agency solicits comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.

VII. Preliminary Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 13771
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.'' We
believe that this proposed rule is not a significant regulatory action
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this rule imposes no new burdens, we propose to
certify that the proposed rule will not have a significant economic
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $148 million, using the most current (2016) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.

B. Summary of Costs and Benefits

    The objective of this proposed rule is to amend the regulations
concerning RFDs of the classification of products as biological
products, devices, drugs, or combination products, or their assignment
to Agency components for premarket review and regulation. The proposed
rule is intended to clarify the scope of the regulations, streamline
and clarify the appeals process, align the regulations with more recent
legislative and regulatory measures, update advisory content, and
otherwise to clarify part 3.
    Many provisions of this proposed rule codify current practices and
may not result in estimated costs, benefits, or savings. However, we
expect a few provisions to lead to changes that may generate additional
public health benefits and cost savings to society. A summary of the
quantified costs and cost savings of the proposed rule are presented in
table 1. The lower and upper estimates given in table 1 are at the 5
and 95 percent interval, respectively.

                          Table 1--Summary of Net Cost Savings of the Proposed Rule 1 2
----------------------------------------------------------------------------------------------------------------
                  Category                          Primary estimate           Low estimate      High estimate
----------------------------------------------------------------------------------------------------------------
Costs......................................  Annualized Monetized $/year..            $17,000            $12,000
                                             Annualized Quantified........
                                             Qualitative..................
----------------------------------------------------------------------------------------------------------------
\1\ We use a 10-year time horizon for this rule with payments occurring at the end of each period.
\2\ All dollar values are rounded to the nearest $1,000.

    The estimated primary costs of the proposed rule include the
additional one-time costs incurred by industry to read and understand
the regulation. We expect only a subset of firms currently producing
medical products will incur this cost. Our primary estimate of the
total up-front cost to industry is approximately $131,000. Annualizing
these costs over a 10-year period, we estimate total annualized costs
to be $15,000 at a 3 percent discount rate, and $17,000 at a 7 percent
discount rate. The present value of these costs over 10 years is
$127,000 at a 3 percent discount rate, and $122,000 at a 7 percent
discount rate.
    The primary public health benefit from adoption of the proposed
rule would be the value of the illnesses and deaths avoided as a result
of finalizing the proposed rule. Current regulatory requirements may
cause applicants to unnecessarily submit RFDs, or to make misguided
judgments regarding the need to confirm product classification or
assignment. The reduction in uncertainty about the RFD process will,
thereby, potentially allow sponsors to make more informed decisions
regarding product development and seeking marketing authorization, and
potentially allow sponsors and FDA personnel to divert resources used
under current regulations to other areas, such as to product
development and marketing applications. We are not able to quantify or
to identify specific ways by which the proposed rule would lead to
avoided illnesses or deaths and therefore do not include public health
benefits in our net estimates.
    FDA is able to quantify the resource savings to both the Agency and
industry from the proposed rule associated with streamlining and
clarifying the appeals process for product classification and
assignments. Our primary estimate of total cost savings to industry and
FDA is approximately $28,000 annually. The present value of these
savings over 10 years is $241,000 at a 3 percent discount rate, and
$198,000 at a 7 percent discount rate. Potential resource savings to
FDA and industry from the optional electronic submission of RFDs are
not included in this estimate because of the uncertainty in the number
of sponsors who would choose to submit electronically.
    Our best estimate of the quantifiable net social effect of the
proposed rule, using a 10-year time horizon, is a cost of approximately
$103,000 in the first year and a cost savings of approximately $28,000
each year starting in the second year. The net present discounted value
of the quantifiable cost savings over 10 years is approximately
$114,000 at a 3 percent discount rate and approximately $76,000 at a 7
percent discount rate. The total annualized net effect of the proposed
rule is estimated to produce an average net cost savings ranging from
$13,000 at a 3 percent discount rate and $11,000 at a 7 percent
discount rate.
    Executive Order 13771 requires that the costs associated with
significant

new regulations ``shall, to the extent permitted by law, be offset by
the elimination of existing costs associated with at least two prior
regulations.'' We believe that the proposed rule, if finalized, is not
significant under Executive Order 12666 and is deregulatory under
Executive Order 13771.
    The present value of our primary net cost savings estimate of the
proposed rule, using an infinite time horizon, is approximately
$281,000, discounted at 7 percent, with a lower bound of approximately
$165,000 and an upper bound of approximately $1.2 million. The
annualized net cost savings of the proposed rule are approximately
$20,000, discounted at 7 percent on an infinite time horizon, with a
lower bound of approximately $12,000 and an upper bound of
approximately $83,000. Discounted at 3 percent, the present value of
our primary net cost savings of the proposed rule is approximately
$814,000, with a lower bound of approximately $634,000 and an upper
bound of approximately $2.9 million. The annualized net cost of the
proposed rule is approximately -$20,000, discounted at 3 percent on an
infinite time horizon, with a lower bound of approximately -$12,000 and
an upper bound of approximately -$83,000. The estimated net costs using
a 7 percent discount rate under Executive Order 13771 are summarized in
table 2.

                 Table 2--Summary of Executive Order 13771 Net Costs of the Proposed Rule 1 2 3
----------------------------------------------------------------------------------------------------------------
                                                                                Lower bound     Upper bound
                                                                   Primary (7%)        (7%)            (7%)
----------------------------------------------------------------------------------------------------------------
Present Value of Costs..........................................        $122,000         $81,000        $192,000
Present Value of Savings........................................         403,000         357,000       1,266,000
Present Value of Net Costs......................................         281,000         165,000       1,184,000
Annualized Costs................................................           9,000           6,000          13,000
Annualized Savings..............................................          28,000          25,000          89,000
Annualized Net Costs............................................         -20,000         -12,000         -83,000
----------------------------------------------------------------------------------------------------------------
\1\ We use an infinite time horizon for this rule with payments occurring at the end of each period.
\2\ All dollar values are rounded to the nearest $1,000.
\3\ A negative net cost implies a net cost savings.

    The Regulatory Flexibility Act requires Agencies to prepare an
initial regulatory flexibility analysis if a proposed rule would have a
significant economic impact on a substantial number of small entities
(including small businesses, small non-profit organizations, and small
governmental jurisdictions). FDA has examined the economic implications
of the proposed rule as required by the Regulatory Flexibility Act.
This rule, if finalized, will not impose any new burdens on small
entities, and thus will not have a significant economic impact on a
substantial number of small entities.
    The full preliminary analysis of economic impacts is available in
the docket for this proposed rule (Ref. 1) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VIII. Proposed Effective Date

    FDA is proposing that any final rule based on this proposed rule
become effective 30 days after the date of its publication in the
Federal Register.

IX. Reference

    The following reference is on display in 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 also
available electronically at https://www.regulations.gov or https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

1. Preliminary Regulatory Impact Analysis of the Proposed Rule,
Amendments to 21 CFR Part 3--Product Jurisdiction, Docket No. FDA-
2004-N-0191.

List of Subjects in 21 CFR Part 3

    Administrative practice and procedure, Biological products,
Combination products, Drugs, Medical devices, Authority delegations.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and authority delegated to the Commissioner
of Food and Drugs, it is proposed that 21 CFR part 3 be amended as
follows:

0
1. The authority citation for part 3 is revised to read as follows:

    Authority:  21 U.S.C. 321, 351, 352, 353, 355, 360, 360c-360f,
360h-360j, 360gg-360ss, 360bbb-2, 371(a), 379e, 381, 394; 42 U.S.C.
216, 262, 264.

0
2. Revise part 3 to read as follows:

PART 3--PRODUCT JURISDICTION

Subpart A--Product Classification and Assignment of Agency
Component for Review of Premarket Applications

Sec.
3.1 Purpose.
3.2 Definitions.
3.3 Scope.
3.4 Designated agency component.
3.5 Request for designation.
3.6 Letter of designation.
3.7 Effect of letter of designation.
3.8 Stay of review time.
Subpart B [Reserved]

Sec.  3.1  Purpose.

    The purpose of this subpart is to provide procedures for
determining whether a product is a biological product, device, drug, or
combination product, and which component within FDA will have primary
jurisdiction for a biological product, device, drug, or combination
product, where product classification or assignment is unclear or in
dispute. By doing so, this subpart implements section 503(g) of the
Federal Food, Drug, and Cosmetic Act. Nothing in this subpart prevents
FDA from using any agency resources it deems necessary to ensure
adequate review of the safety and effectiveness of any product, or the
substantial equivalence of any device to a predicate device.

Sec.  3.2  Definitions.

    For the purpose of this part:
    Agency means the Food and Drug Administration.
    Agency component means the Center for Biologics Evaluation and
Research, the Center for Devices and Radiological Health, the Center
for Drug Evaluation and Research, or alternative organizational
component of the agency.
    Applicant means any person who submits or plans to submit an
application to the Food and Drug Administration for premarket review.
For purposes of this section, the terms ``sponsor'' and ``applicant''
have the same meaning.

    Application means any investigational new drug application,
investigational device exemption application, new drug application,
abbreviated new drug application, biologics license application,
premarket notification submission, De Novo classification request,
premarket approval application, product development protocol, or
humanitarian device exemption application, including all amendments and
supplements.
    Biological product has the meaning given the term in section 351(i)
of the Public Health Service Act (42 U.S.C. 262(i)).
    Combination product includes:
    (1) A product comprised of two or more regulated components, i.e.,
drug/device, biological product/device, drug/biological product, or
drug/device/biological product, that are physically, chemically, or
otherwise combined or mixed and produced as a single entity;
    (2) Two or more separate products packaged together in a single
package or as a unit and comprised of drug and device products, device
and biological products, or biological and drug products;
    (3) A drug, device, or biological product packaged separately that
according to its investigational plan or proposed labeling is intended
for use only with an approved individually specified drug, device, or
biological product where both are required to achieve the intended use,
indication, or effect and where upon approval of the proposed product
the labeling of the approved product would need to be changed, e.g., to
reflect a change in intended use, dosage form, strength, route of
administration, or significant change in dose; or
    (4) Any investigational drug, device, or biological product
packaged separately that according to its proposed labeling is for use
only with another individually specified investigational drug, device,
or biological product where both are required to achieve the intended
use, indication, or effect.
    Constituent part has the meaning given the term in Sec.  4.2 of
this chapter.
    Device has the meaning given the term in section 201(h) of the
Federal Food, Drug, and Cosmetic Act.
    Drug has the meaning given the term in section 201(g)(1) of the
Federal Food, Drug, and Cosmetic Act.
    FDA means Food and Drug Administration.
    Letter of designation means the written notice issued by the
product jurisdiction officer classifying the product, specifying the
agency component with primary jurisdiction, or both.
    Letter of request means an applicant's written submission to the
product jurisdiction officer seeking product classification, the
designation of the agency component with primary jurisdiction, or both.
    Mode of action is the means by which a product achieves an intended
therapeutic effect or action. For purposes of this definition,
``therapeutic'' action or effect includes any effect or action of the
combination product intended to diagnose, cure, mitigate, treat, or
prevent disease, or affect the structure or any function of the body.
When making assignments of combination products under this part, the
agency will consider three types of mode of action: The actions
provided by a biological product, a device, and a drug. Each
constituent part of a combination product has one such type of mode of
action. For purposes of combination product assignment:
    (1) A constituent part has a biological product mode of action if
it acts by means of a virus, therapeutic serum, toxin, antitoxin,
vaccine, blood, blood component or derivative, allergenic product,
protein (except any chemically synthesized polypeptide), or analogous
product, or arsphenamine or derivate of arsphenamine (or any other
trivalent organic arsenic compound), applicable to the prevention,
treatment, or cure of a disease or condition of human beings, as
described in section 351(i) of the Public Health Service Act.
    (2) A constituent part has a device mode of action if it meets the
definition of device contained in section 201(h) of the Federal Food,
Drug, and Cosmetic Act, and it does not have a biological product mode
of action.
    (3) A constituent part has a drug mode of action if it meets the
definition of drug contained in section 201(g)(1) of the Federal Food,
Drug, and Cosmetic Act, and it does not have a biological product or
device mode of action.
    Premarket review includes the examination of data and information
submitted by an applicant.
    Primary mode of action is the single mode of action of a
combination product that provides the most important therapeutic action
of the combination product. The most important therapeutic action is
the mode of action expected to make the greatest contribution to the
overall intended therapeutic effects of the combination product.
    Product means any article that contains any drug as defined in
section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act; any
device as defined in section 201(h) of the Federal Food, Drug, and
Cosmetic Act; or any biological product as defined in section 351(i) of
the Public Health Service Act (42 U.S.C. 262(i)).
    Product jurisdiction officer is the person or persons in the Office
of Combination Products responsible for classification of products as
biological products, devices, drugs, and combination products and for
designating the component of FDA with primary jurisdiction for the
premarket review and regulation of such products.
    Sponsor means ``applicant'' as defined in this section.

Sec.  3.3  Scope.

    This subpart applies to sponsors for products for which
classification as a drug, device, biological product, or combination
product, or the agency component with primary jurisdiction, is unclear
or in dispute.

Sec.  3.4  Designated agency component.

    (a) To designate the agency component with primary jurisdiction for
the premarket review and regulation of a combination product, the
agency shall determine the primary mode of action of the product. Where
the primary mode of action is that of:
    (1) A drug (other than a biological product), the agency component
charged with premarket review of such drugs shall have primary
jurisdiction;
    (2) A device, the agency component charged with premarket review of
such devices shall have primary jurisdiction;
    (3) A biological product, the agency component charged with
premarket review of such biological products shall have primary
jurisdiction.
    (b) In some situations, it is not possible to determine, with
reasonable certainty, which one mode of action will provide a greater
contribution than any other mode of action to the overall therapeutic
effects of the combination product. In such a case, the agency will
assign the combination product to the agency component that regulates
other combination products that present similar questions of safety and
effectiveness with regard to the combination product as a whole. When
there are no other combination products that present similar questions
of safety and effectiveness with regard to the combination product as a
whole, the agency will assign the combination product to the agency
component with the most expertise related to the most significant
safety and effectiveness questions presented by the combination
product.
    (c) The agency component with primary jurisdiction for the
premarket review and regulation of a product will

consult with other agency components, as FDA deems appropriate.

Sec.  3.5  Request for designation.

    (a) What to file: A request for designation may be submitted only
by the sponsor and must be filed in accordance with this section. The
request for designation must not exceed 15 pages, including
attachments, and must set forth:
    (1) The identity of the sponsor, including company name and
address, establishment registration number, company contact person,
email address, and telephone number.
    (2) A description of the product, including:
    (i) Classification, name of the product and all component products,
if applicable;
    (ii) Common, generic, or usual name of the product and all
component products;
    (iii) Proprietary name of the product;
    (iv) Identification of any component of the product that already
has received premarket approval, is marketed as not being subject to
premarket approval, or has received an investigational exemption, the
identity of the sponsors, and the status of any discussions or
agreements between the sponsors regarding the use of this product as a
component of a new combination product.
    (v) Chemical, physical, or biological composition;
    (vi) Status and brief reports of the results of developmental work,
including animal testing;
    (vii) Description of the manufacturing processes, including the
sources of all components;
    (viii) Proposed use or indications;
    (ix) Description of all known modes of action, the sponsor's
identification of the single mode of action that provides the most
important therapeutic action of the product, and the basis for that
determination;
    (x) Schedule and duration of use;
    (xi) Dose and route of administration of drug or biological
product;
    (xii) Description of related products, including the regulatory
status of those related products; and
    (xiii) Any other relevant information.
    (3) The sponsor's recommendation as to the classification of the
product as a drug, device, biological product, or combination product,
or as to which agency component should have primary jurisdiction. For
combination products, the recommendation for primary jurisdiction must
be based on the primary mode of action unless the sponsor cannot
determine with reasonable certainty which mode of action provides the
most important therapeutic action of the combination product, in which
case the sponsor's recommendation must be based on the assignment
algorithm set forth in Sec.  3.4(b) and an assessment of the assignment
of other combination products the sponsor wishes FDA to consider during
the assignment of its combination product.
    (b) How and where to file: All communications pursuant to this
subpart shall be addressed to the attention of the product jurisdiction
officer and plainly marked ``Request for Designation.'' Such
communications shall be submitted either in hard copy (an original and
two copies) or in an electronic format that FDA can process, review,
and archive, to the current mailing address or email address,
respectively, for the Office of Combination Products as published by
FDA.

Sec.  3.6  Letter of designation.

    (a) Each request for designation will be reviewed for completeness
within 5 working days of receipt. Any request for designation
determined to be incomplete will be returned to the applicant with a
request for the missing information. The sponsor of an accepted request
for designation will be notified of the filing date.
    (b) Within 60 days of the filing date of a request for designation,
the product jurisdiction officer will issue a letter of designation to
the sponsor, with copies to the agency components, specifying the
classification of the product at issue or the agency component
designated to have primary jurisdiction for the premarket review and
regulation of the product at issue, and any consulting agency
components. The product jurisdiction officer may request a meeting with
the sponsor during the review period to discuss the request for
designation. If the product jurisdiction officer has not issued a
letter of designation within 60 days of the filing date of a request
for designation, the sponsor's recommendation of the classification of
the product or the center with primary jurisdiction, in accordance with
Sec.  3.5(a)(3), shall become the designated product classification or
agency component.

Sec.  3.7  Effect of letter of designation.

    (a) The letter of designation constitutes an agency determination
that is subject to change only as provided in paragraph (b) of this
section.
    (b) The product jurisdiction officer may change the designated
product classification or agency component with the written consent of
the sponsor, or without its consent to protect the public health or for
other compelling reasons. A sponsor shall be given 30 days written
notice of any proposed such change in designated product classification
or agency component. The sponsor may request an additional 30 days to
submit written objections, not to exceed 15 pages, to the proposed
change, and shall be granted, upon request, a timely meeting with the
product jurisdiction officer and appropriate center officials. Within
30 days of receipt of the sponsor's written objections, the product
jurisdiction officer shall issue to the sponsor, with copies to
appropriate agency component officials, a written determination setting
forth a statement of reasons for the proposed change in designated
product classification or agency component. Such a change in the
designated product classification or agency component requires the
concurrence of the official in the agency responsible for overseeing
the Office of Combination Products.

Sec.  3.8  Stay of review time.

    Any filing with or review by the product jurisdiction officer stays
the review clock or other established time periods for agency action
for an application during the pendency of the review by the product
jurisdiction officer.

Subpart B [Reserved]

    Dated: May 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10321 Filed 5-14-18; 8:45 am]
 BILLING CODE 4164-01-P


                                                                        6560-50
ENVIRONMENTAL PROTECTION AGENCY

 [EPA-HQ-ORD-2021-0601; FRL - ]

 Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Underground Storage Tank Finder Application

AGENCY:	Environmental Protection Agency (EPA).
ACTION:	Notice.
SUMMARY:	The Environmental Protection Agency has submitted an information collection request (ICR), "Underground Storage Tank Finder Application" (EPA ICR No. 2696.01, OMB Control No. 2050-NEW), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a request for approval of a new collection. Public comments were previously requested via the Federal Register (87 FR 56656) on September 15, 2022 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
 DATES: Additional comments may be submitted on or before [insert date 30 days after publication in the Federal Register].
ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-ORD-2021-0601, to EPA online using https://www.regulations.gov/ (our preferred method), by email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave., NW, Washington, DC 20460.
Submit written comments and recommendations to OMB's Office of Information and Regulatory Affairs using the interface at 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 EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.
FOR FURTHER INFORMATION CONTACT: Alexander Hall, Office of Research and Development, Center for Environmental Solutions and Emergency Response, Environmental Protection Agency, 26 West Martin Luther King Drive, Cincinnati, OH 45268; telephone number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
	Supporting documents that explain in detail the information that the EPA will collect are available in the public docket for this ICR. The docket can be viewed online at https://www.regulations.gov or in person at the EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is<PHONE_NUMBER>. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.
Abstract: The EPA recently developed the Underground Storage Tank (UST) Finder application (hereafter ``UST Finder''). UST Finder is a publicly available web map application containing a comprehensive, state-sourced national map of UST and leaking underground storage tank (LUST) data. UST Finder is available via EPA's GeoPlatform at https://gispub.epa.gov/ustfinder. UST Finder provides users access to information on the attributes and locations of active and closed USTs, UST facilities, and LUSTs in states in a geographic information system (GIS) environment. The application provides users with geospatial information about UST facilities and LUST sites, resulting in better understanding and assessment of vulnerability to human health and the environment. UST Finder also contains information about proximity of UST facilities and LUST sites to surface and groundwater public drinking water protection areas; the estimated number of private domestic wells and number of people living nearby; and areas prone to floods, wildfires, earthquakes, and other hazards. UST Finder may be used to import additional geospatial data layers of interest or to export UST facility and LUST site information for use by other software programs. The underlying data accessible in UST Finder are publicly available and free to use.
      This information collection relates to information that state and territorial agencies already collect from UST and LUST owners and operators as part of their customary business practice to manage their compliance and enforcement programs. To successfully implement, maintain, and improve the data quality and usability of UST Finder, the Agency seeks to gather, on a voluntary basis, information from state and territorial agencies that oversee UST/LUST programs. Specifically, EPA will request that these agencies provide location and other relevant data about USTs and LUSTs that are already being collected and managed by states and territories. The UST Finder application may be used for many purposes, such as helping regulators, owners, and operators in decision-making; prioritizing site cleanups or inspections; triaging risk; and identifying sites that may be more likely to have a release based on UST age and substance stored. The application may also be used by emergency response personnel to protect UST facilities from extreme weather events. After disasters, UST Finder can be used to rapidly identify LUST site cleanups impacted by natural disasters and assist in restarting cleanups after these events.
      To have a dynamic database that provides more detailed and current data, the EPA intends to request UST/LUST data from state and territorial agencies that oversee UST/LUST programs. This information collection is voluntary and does not require the agencies to collect additional data on USTs/LUSTs beyond the data elements that are already being collected through their previously implemented programs. States and territories will decide the extent of information to be provided. The EPA intends to implement four options for collecting the UST/LUST data from states and territories: (1) by developing an Exchange server or other automated service through which states can ``push'' their data to the EPA, (2) by developing a link to the agencies' pre-existing electronic service used to maintain public websites such that the EPA can ``pull'' the data, (3) by allowing states and territories to submit existing databases or spreadsheets through an approved file sharing method, or (4) by EPA obtaining publicly available data from state and territory public agency websites (an option that will be exercised if states and territories do not voluntarily submit their data). For all data transfer options, the EPA will standardize, curate, and enter records into the UST Finder application. The EPA does not intend to collect any data that would be considered confidential business information.
Form Numbers: None.
Respondents/affected entities: States and territories with delegated authority to operate UST and LUST programs under 40 CFR parts 280, 281, 282, and 40 CFR 302.4.
Respondent's obligation to respond: Voluntary.
Estimated number of respondents: 56 (total). This includes the 50 states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.
Frequency of response: Semiannually.
Total estimated burden: 3,470 hours (per year). Burden is defined at 5 CFR 1320.3(b).
Total estimated cost: $175,000 (per year), includes $0 annualized capital or operation and maintenance costs.
Changes in the Estimates: This is a new information collection, therefore, there are no previous burden estimates. The estimated burden reflects assumptions based on Agency experience from the development of the UST Finder application and consultation with affected entities. No comments were received on the burden previously published in the Federal Register. Should the EPA request to extend this information collection 3 years from now, changes in burden will be evaluated at that time.
Dated: _____________________________________
___________________________________________
Charlotte Coleman, Deputy Director, Center for Environmental Solutions and Emergency Response (CESER), Office of Research and Development.


[Federal Register: December 28, 2005 (Volume 70, Number 248)]
[Notices]
[Page 76828-76829]
[DOCID:fr28de05-116]

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

ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0176; FRL-7748-8]

Mancozeb Reregistration Eligibility Decision

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the availability of EPA's Reregistration
Eligibility Decision (RED) for the pesticide mancozeb. The Agency's
risk assessments and other related documents are also available in the
mancozeb Docket. Mancozeb is a member of the ethylene
bisdithiocarbamate (EBDC) group of fungicides, which also includes the
related fungicides maneb and metiram. Mancozeb is used as a broad
spectrum fungicide on a variety of agricultural crops, ornamentals, and
turf. As a part of this process, the Agency announced the availability
of the EBDCs preliminary risk assessments and supporting documents for
a 90-day comment period and requested risk reduction options under
docket identification (ID) number EPA-HQ-OPP;2004-0078. Through these
programs, EPA is ensuring that all pesticides meet current health and
safety standards.

FOR FURTHER INFORMATION CONTACT: Christina Scheltema, Special Review
and Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others may also be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this
action under docket ID number OPP-2005-0176. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although, a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at
the Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-
5805.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.

     EDOCKET, epa's electronic public docket and comment system was
replaced on November 25, 2005, by an enhanced Federal-wide electronic
docketmanagement and comment system located at http://www.regulations.gov/.
 Follow the on-line instructions

     An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public

comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search''
then key in the appropriate docket ID number.

II. Background

A. What Action is the Agency Taking?

     Under section 4 of the Federal Insecticide, Fungicide, and
Rodenticide

Act (FIFRA), EPA is reevaluating existing pesticides to ensure that
they meet current scientific and regulatory standards. EPA has
completed a Reregistration Eligibility Decision (RED) for the
pesticide, mancozeb under section 4(g)(2)(A) of FIFRA. Mancozeb is an
EBDC fungicide used on a variety of agricultural crops, ornamentals,
and turf. EPA has determined that the data base to support
reregistration is substantially complete and that products containing
mancozeb are eligible for reregistration depending on their specific
uses, provided that the risk mitigation measures outlined in the RED
are adopted, and labels are amended to reflect these measures.
Registrants have requested cancellations and/or deletions of mancozeb
use as a foliar treatment for cotton, use in pineapple propagation, and
use on residential lawns, athletic fields, and pachysandra; these uses
are not eligible for reregistration. Upon submission of any required
product specific data under section 4(g)(2)(B) and any necessary
changes to the registration and labeling (either to address concerns
identified in the RED or as a result of product specific data), EPA
will make a final reregistration decision under section 4(g)(2)(C) for
products containing mancozeb.
     EPA must review tolerances and tolerance exemptions that were in
effect when the Food Quality Protection Act (FQPA) was enacted in
August 1996, to ensure that these existing pesticide residue limits for
food and feed commodities meet the safety standard established by the
new law. Tolerances are considered reassessed once the safety finding
has been made or a revocation occurs. EPA has reviewed and made the
requisite safety finding for the mancozeb tolerances included in this
notice.
     EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and Reregistration; Public
Participation Process, published in the Federal Register on May 14,
2004, (69 FR 26819) (FRL-7357-9) explains that in conducting these
programs, EPA is tailoring its public participation process to be
commensurate with the level of risk, extent of use, complexity of
issues, and degree of public concern associated with each pesticide.
Due to its uses, risks, and other factors, mancozeb was reviewed
through the modified 4-Phase public participation process. Through this
process, EPA worked extensively with stakeholders and the public to
reach the regulatory decisions for mancozeb.
     The reregistration program is being conducted under
Congressionally mandated time frames, and EPA recognizes the need both
to make timely decisions and to involve the public. Opportunities for
public comment were offered as this decision was being developed.
Additionally, all issues related to this pesticide were resolved
through consultations with stakeholders. The Agency, therefore, is
issuing the mancozeb RED without a comment period.

B. What is the Agency's Authority for Taking this Action?

     Section 4(g)(2) of FIFRA as amended directs that, after submission
of all data concerning a pesticide active ingredient, ``the
Administrator shall determine whether pesticides containing such active
ingredient are eligible for reregistration,'' before calling in product
specific data on individual end-use products and either reregistering
products or taking other ``appropriate regulatory action.''
     Section 408(q) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(q), requires EPA to review tolerances and
exemptions for pesticide residues in effect as of August 2, 1996, to
determine whether the tolerance or exemption meets the requirements of
section 408(b)(2) or (c)(2) of FFDCA. This review is to be completed by
August 3, 2006.

List of Subjects

     Mancozeb, EBDC fungicides, Environmental protection, Pesticides
and pests.

    Dated: December 15, 2005.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 05-24465 Filed 12-27-05; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 84, Number 59 (Wednesday, March 27, 2019)]
[Notices]
[Page 11597]
[FR Doc No: 2019-05812]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85388; File No. SR-CboeBZX-2019-001]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change, as Modified by Amendment No. 1, To List and Trade Under BZX
Rule 14.11(c)(3) Shares of the Global X Russell 2000 Covered Call ETF
of Global X Funds

March 21, 2019.
    On January 28, 2019, Cboe BZX Exchange, Inc. (``Exchange'' or
``BZX'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to list and trade under Rule 14.11(c)(3) shares of
the Global X Russell 2000 Covered Call ETF (``Fund'') of Global X
Funds. The proposed rule change was published for comment in the
Federal Register on February 15, 2019.\3\ On March 14, 2019, the
Exchange filed Amendment No. 1 to the proposed rule change, which
amended and replaced the proposed rule change as originally filed.\4\
The Commission has received no comment letters on the proposed rule
change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 85099 (Feb. 11,
2019), 84 FR 4584.
    \4\ Amendment No. 1 to the proposed rule change is available on
the Commission's website at: https://www.sec.gov/comments/sr-cboebzx-2019-001/srcboebzx2019001-5145199-183369.pdf.
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    Section 19(b)(2) of the Act \5\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is April 1, 2019. The Commission is extending this 45-day time period.
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    \5\ 15 U.S.C. 78s(b)(2).
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    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider the proposed rule change, as
modified by Amendment No. 1. Accordingly, the Commission, pursuant to
Section 19(b)(2) of the Act,\6\ designates May 16, 2019, as the date by
which the Commission shall either approve or disapprove, or institute
proceedings to determine whether to disapprove, the proposed rule
change, as modified by Amendment No. 1 (File No. SR-CboeBZX-2019-001).
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    \6\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(31).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-05812 Filed 3-26-19; 8:45 am]
BILLING CODE 8011-01-P