[Federal Register Volume 84, Number 247 (Thursday, December 26, 2019)]
[Notices]
[Pages 70976-70979]
[FR Doc No: 2019-27799]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4739]

Requesting Food and Drug Administration Feedback on Combination
Products; Draft Guidance for Industry and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Requesting
FDA Feedback on Combination Products.'' The purpose of this guidance is
to discuss ways in which combination product sponsors can obtain
feedback from FDA on scientific and regulatory questions and to
describe best practices for FDA and sponsors when interacting on these
topics. These interactions can occur through application-based
mechanisms, such as the pre-submission process used in the Center for
Devices and Radiological Health (CDRH) and the Center for Biologics and
Research (CBER) and the formal meetings used in the Center for Drug
Evaluation and Research (CDER) and CBER, or through Combination Product
Agreement Meetings (CPAMs), as appropriate.

DATES: Submit either electronic or written comments on the draft
guidance by February 24, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that

identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-4739 for ``Requesting FDA Feedback on Combination
Products.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Office of Combination Products, Food and Drug Administration, Bldg.
32, Rm. 5129, 10903 New Hampshire Ave., Silver Spring, MD 20993. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Melissa Burns, Office of Combination
Products, Food and Drug Administration,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
and FDA staff entitled ``Requesting FDA Feedback on Combination
Products.'' The purpose of this guidance is to discuss ways in which
combination product sponsors can obtain feedback from the Agency on
scientific and regulatory questions. These interactions can occur
through application-based mechanisms, such as the pre-submission
process used in CDRH and CBER and the formal meetings used in CDER and
CBER, or through CPAMs, as appropriate.
    We are publishing this guidance consistent with the Agency's
ongoing commitment to enhancing clarity and transparency regarding
regulatory considerations for combination products, and in accordance
with the mandate under section 503(g)(8)(C)(vi) of the Federal Food,
Drug, and Cosmetics Act (FD&C Act) (21 U.S.C. 353(g)(8)(C)(vi)), which
was added by section 3038 of the 21st Century Cures Act (Pub. L. 114-
255) (Cures Act). Section 503(g)(8)(C)(vi) requires FDA to issue a
final guidance addressing: (1) The structured process for managing pre-
submission interactions with sponsors developing combination products;
(2) best practices to ensure FDA feedback in such pre-submission
interactions represents the Agency's best advice based on the
information provided during these pre-submission interactions; and (3)
how CPAMs relate to other FDA meeting types, what information should be
submitted prior to a CPAM, and the form and content of agreements
reached through a CPAM.
    FDA is in the process of operationalizing the procedures related to
submission and receipt of a CPAM request. Therefore, if a sponsor
wishes to submit a CPAM request to FDA at this time, the sponsor should
first contact the Product Jurisdiction Office for the lead Center
<EMAIL_ADDRESS>
<EMAIL_ADDRESS>or
<EMAIL_ADDRESS>and the Office of Combination
Products<EMAIL_ADDRESS>prior to submitting a CPAM request
to help ensure that the CPAM request is efficiently received and
processed by FDA.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Requesting
FDA Feedback on Combination Products.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ''Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance

of FDA's functions, including whether the information will have
practical utility; (2) the accuracy of FDA's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Combination Product Agreement Meetings Under FD&C Act
Section 503(g)(2)(A)(i); Requesting FDA Feedback on Combination
Products.
    Description of Respondents: Respondents to this collection of
information are combination product sponsors that submit CPAM requests.
    Burden Estimate: This draft guidance includes recommendations
regarding information that sponsors should include in CPAM requests.
Specifically, the draft guidance states that for CPAM requests,
sponsors should:\1\
---------------------------------------------------------------------------

    \1\ The draft guidance also notes that combination products must
be identified as such in CPAM requests under section
503(g)(8)(C)(v)(I) of the FD&C Act.
---------------------------------------------------------------------------

     Product Information.
    [cir] Include the product name, description of the overall
combination product and constituent parts, indications for use
statement, and, as applicable, route of administration and dosing
information.
    [cir] Include, as relevant:
    [ssquf] For a drug- or biological product-led combination product
that includes a device constituent part, a device description, design
diagram or other image, and identify components that are part of the
device.
    [ssquf] For a device-led combination product, provide the chemical
name, established or proper name (if available), and structure, for the
drug and/or biological product constituent part(s).
    [ssquf] For a device-led combination product, provide the route of
administration and/or dosing information for the drug and/or biological
product constituent part(s).
    [ssquf] For combination products that contain an active ingredient
that is included in an approved drug product that the sponsor seeks to
cross reference or rely upon in its submission, identify the
application number of the approved product.
    [ssquf] For combination products that contain a device constituent
part that is a cleared or approved device that the sponsor seeks to
cross reference, identify the application or submission number for the
previously cleared or approved device.
     Background. Describe the status of product development,
summarize any previous interactions with FDA on the product, including
applications, application-based mechanisms, other meetings, Request for
Designations (RFDs) or pre-RFDs, and identify the proposed regulatory
pathway if not already established.
     Meeting Request. Include the requested form of
communication (i.e., face-to-face meeting, teleconference, or written
response). Summarize why the specific communication format is
appropriate. If proposing a face-to-face meeting or teleconference,
provide three proposed meeting dates/times, dates and times when the
sponsor is not available, and a proposed agenda.
     Agreement Proposals Generally. Identify the specific
proposals for which the sponsor seeks FDA agreement. Proposals should
be grouped by discipline (e.g., Pharmacology/Toxicology, Pharmaceutical
Quality/Chemistry and Manufacturing Controls (CMC), Engineering, Human
Factors) where possible. The proposals should be limited to those for
which the sponsor is seeking agreement from FDA.
     Rationale and Data Supporting Proposals. Provide
rationale(s) and data adequate to support FDA's review of the agreement
proposals. Organize the rationale(s) and data by topic when
appropriate.
     Attendees. Include a list of planned participants from the
sponsor's organization, including names and titles. A list of names,
titles and affiliations of consultants and interpreters should also be
included. If this information changes, it should be updated no later
than 5 business days prior to the meeting. If the sponsor wishes to
request that a specific FDA staff member or expertise be included in
the meeting, that information should be included in the CPAM request.
    FDA has not received any CPAM requests since the enactment of the
Cures Act in December 2016. FDA estimates that less than one CPAM
request will be received per year by each medical product center (CBER,
CDER, and CDRH). To provide a conservative estimate of burden, FDA
estimates that approximately one CPAM request will be submitted per
year to each medical product center. FDA estimates that it will take
sponsors approximately 25 hours to compile and draft the information
that this draft guidance recommends should be included in a CPAM
request.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
           FDA center                Number of     responses per   Total annual      Hours per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
CDER............................               1               1               1              25              25
CDRH............................               1               1               1              25              25
CBER............................               1               1               1              25              25
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................  ..............  ..............  ..............  ..............              75
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    This draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
pertaining to orphan drug provisions in 21 CFR part 316 are approved
under OMB control number 0910-0167; the collections of information
pertaining to investigational device exemption submission provisions in
21 CFR part 812 are approved under OMB control number 0910-0078; the
collections of information pertaining to investigational new drug
submission provisions in 21 CFR part 312 are approved under OMB control
number 0910-0014; and the collections of information pertaining to
biologics licensing submission

provisions in 21 CFR part 601 are approved under OMB control number
0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/combination-products/guidance-regulatory-information/combination-products-guidance-documents or https://www.regulations.gov.

    Dated: December 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27799 Filed 12-23-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: July 24, 2009 (Volume 74, Number 141)]
[Rules and Regulations]
[Page 36605-36607]
[DOCID:fr24jy09-3]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2009-0659]
RIN 1625-AA08

Special Local Regulations for Marine Events; Port Huron to
Mackinac Island Sail Race

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard will enforce a special local regulation for
the annual Port Huron to Mackinac Island Sail Race. This action is
necessary to safely control vessel movements in the vicinity of the
race starting point and provide for the safety of the general boating
public and commercial shipping. During this period, no person or vessel
may enter the regulated area without the permission of the Coast Guard
Patrol Commander (``PATCOM'').

DATES: This rule is effective from 9 a.m. through 4 p.m. on July 25,
2009.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2009-0659 and are available online
by going to http://www.regulations.gov, selecting the Advanced Docket
Search option on the right side of the screen, inserting USCG-2009-0659
in the Docket ID box, pressing Enter, and then clicking on the item in
the Docket ID column. They are also available for inspection or copying
at the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions concerning this
temporary rule, call or e-mail Mr. Frank Jennings, Jr., Enforcement
Branch, Ninth Coast Guard District, 1240 East 9th Street, Cleveland,
OH, via e-mail at<EMAIL_ADDRESS>or by phone at: (216) 902-
6094. If you have questions on viewing the docket, call Renee V.
Wright, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the special local regulation
pertaining to this annual race was previously published in the Code of
Federal Regulations, but inadvertently removed during the most recent
revision to 33 CFR 100.901. Because this is an annual race, held in the
same location, local maritime interests are already familiar with the
provisions of these regulations. Based on the late discovery of the
missing permanent rule, the hazards associated with marine regattas
within Port Huron and the short amount of time until the event,
delaying publication of this regulation would be contrary to the public
interest.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. The special local regulation
pertaining to this annual race was previously published in the Code of
Federal Regulations, but inadvertently removed during the most recent
revision to 33 CFR 100.901. Because this is an annual race, held in the
same location, local maritime interests are already familiar with the
provisions of these regulations. Delaying this rule would be contrary
to the public interest of ensuring the safety of spectators and vessels
during this operation and immediate action is necessary to prevent
possible loss of life or property.

Background and Purpose

    Special local regulations are necessary to safely control vessel
movements in the vicinity of the race starting point and provide for
the safety of the general boating public and commercial shipping. The
Captain of the Port Detroit has determined that the start of the Port
Huron to Mackinac Island Sail Race does pose significant risks to
public safety and property. The likely combination of congested
waterways, vessels engaged in a regatta, and fast currents could easily
result in serious injuries or fatalities.

Discussion of Rule

    The Coast Guard will enforce special local regulations for the
annual Port Huron to Mackinac Sail Race from 9 a.m. until 4 p.m. on
July 25, 2009. The special local regulations apply to the waters of the
Black River, St. Clair River and lower Lake Huron from:

------------------------------------------------------------------------
             Latitude                             Longitude
------------------------------------------------------------------------
42[deg]58.8[min] N................  082[deg]26[min] W, to
42[deg]58.4[min] N................  082[deg]24.8[min] W, thence
                                     northward along the International
                                     Boundary to
43[deg]02.8[min] N................  082[deg]23.8[min] W, to
43[deg]02.8[min] N................  082[deg]26.8[min] W, thence
                                     southward along the U.S. shoreline
                                     to
42[deg]58.9[min] N................  082[deg]26[min] W, thence to
42[deg]58.8[min] N................  082[deg]26[min] W.
------------------------------------------------------------------------

    [DATUM: NAD 1983].
    In order to ensure the safety of spectators and participating
vessels, the special local regulations will be in effect for the day of
the start of the event. The Coast Guard will patrol the race area under
the direction of a designated Coast Guard Patrol Commander

(``PATCOM''). Vessels desiring to transit the regulated area may do so
only with prior approval of the PATCOM and when so directed by that
officer. The PATCOM may be contacted on Channel 16 (156.8 MHZ) by the
call sign ``Coast Guard Patrol Commander.'' Vessels will be operated at
a no wake speed to reduce the wake to a minimum, and in a manner which
will not endanger participants in the event or any other craft. The
rules contained in the above two sentences shall not apply to
participants in the event or vessels of the patrol operating in the
performance of their assigned duties.
    In the event these special local regulations affect shipping,
commercial vessels may request permission from the PATCOM to transit
the area of the event by hailing call sign ``Coast Guard Patrol
Commander'' on Channel 16 (156.8 MHZ).

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to transit
or anchor in a portion of the Black River, St. Clair River and lower
Lake Huron from 9 a.m. until 4 p.m. July 25, 2009.
    These special local regulations will not have a significant
economic impact on a substantial number of small entities for the
following reasons. This rule will be enforced for only 7 hours on a
weekend when the majority of vessel traffic transiting the area is
recreational. Vessel traffic will be allowed to pass through the area
of the race start with the permission of the Coast Guard patrol
commander. Before the effective period, the Coast Guard will issue
maritime advisories widely to users of the river.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small
entities in understanding the rule so that they could better evaluate
its effects on them and participate in the rulemaking process. Small
businesses may send comments on the actions of Federal employees who
enforce, or otherwise determine compliance with, Federal regulations to
the Small Business and Agriculture Regulatory Enforcement Ombudsman and
the Regional Small Business Regulatory Fairness Boards. The Ombudsman
evaluates these actions annually and rates each agency's responsiveness
to small business. If you wish to comment on actions by employees of
the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard
will not retaliate against small entities that question or complain
about this rule or any policy or action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or Tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure we do
discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not affect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    The Coast Guard recognizes the treaty rights of Native American
Tribes. Moreover, the Coast Guard is committed to working with Tribal
Governments to implement local policies and to mitigate Tribal
concerns. We have determined that these regulations and fishing rights
protection need not be incompatible. We have also determined that this
Rule does not have Tribal implications under Executive Order 13175,
Consultation and Coordination with Indian Tribal Governments, because
it does not 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. Nevertheless, Indian Tribes
that have questions concerning the provisions of this Rule or options
for compliance are encouraged to contact the point of contact listed
under FOR FURTHER INFORMATION CONTACT.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs

has not designated it as a significant energy action. Therefore, it
does not require a Statement of Energy Effects under Executive Order
13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(h), of the Instruction. This rule involves the enforcement of
special local regulations, pursuant to 33 CFR 100, for the annual Port
Huron to Mackinac Island Sail Race, July 25, 2009 at 9 a.m. to July 25,
2009 at 4 p.m. This action is necessary to safely control vessel
movements in the vicinity of the start of the race and provide for the
safety of the general boating public and commercial shipping.
Regulations will be in effect for seven hours on the day the event
starts. The Coast Guard will patrol the race area under the direction
of a designated Coast Guard Patrol Commander.
    An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR Part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority: 33 U.S.C. 1233.

0
2. A new temporary Sec.  100.35T09-0659 is added as follows:

Sec.  100.35T09-0659  Special Local Regulations for Marine Events; Port
Huron to Mackinac Island Sail Race.

    (a) Location. The special local regulations apply to the waters of
the Black River, St. Clair River and lower Lake Huron from:

------------------------------------------------------------------------
             Latitude                             Longitude
------------------------------------------------------------------------
42[deg]58.8[min] N................  082[deg]26[min] W, to
42[deg]58.4[min] N................  082[deg]24.8[min] W, thence
                                     northward along the International
                                     Boundary to
43[deg]02.8[min] N................  082[deg]23.8[min] W, to
43[deg]02.8[min] N................  082[deg]26.8[min] W, thence
                                     southward along the U.S. shoreline
                                     to
42[deg]58.9[min] N................  082[deg]26[min] W, thence to
42[deg]58.8[min] N................  082[deg]26[min] W.
------------------------------------------------------------------------

    [DATUM: NAD 1983].
    (b) Effective period. This rule is effective from 9 a.m. to 4 p.m.
on July 25, 2009.
    (c) Regulations.
    (1) In accordance with the general regulations in section 100.35 of
this part, the Coast Guard will patrol the regatta area under the
direction of a designated Coast Guard Patrol Commander (``PATCOM'').
The PATCOM may be contacted on Channel 16 (156.8 MHz) by the call sign
``Coast Guard Patrol Commander.'' Vessels desiring to transit the
regulated area may do so only with prior approval of the PATCOM and
when so directed by that officer.
    (2) Vessels will be operated at a no wake speed to reduce the wake
to a minimum, and in a manner which will not endanger participants in
the even or any other craft. The rules in this subparagraph shall not
apply to participants in the event or vessels of the patrol operating
in the performance of their assigned duties.
    (3) The PATCOM may direct the anchoring, mooring or movement of any
boat or vessel within the regatta area. A succession of sharp, short
signals by whistle or horn from vessels patrolling the area under the
direction of the U.S. Coast Guard PATCOM shall serve as a signal to
stop. Vessels so signaled shall stop and shall comply with the orders
of the PATCOM. Failure to do so may result in expulsion from the area,
citation for failure to comply, or both.
    (4) The PATCOM may establish vessel size and speed limitations and
operating conditions. The PATCOM may restrict vessel operation within
the regatta area to vessels having particular operating
characteristics. The PATCOM may terminate the marine event or the
operation of vessel at any time it is deemed necessary for the
protection of life and property.

    Dated: July 10, 2009.
F.M. Midgette,
Captain, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. E9-17748 Filed 7-23-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)]
[Rules and Regulations]
[Pages 14636-14639]
[FR Doc No: 2017-05703]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0606; FRL-9959-12]

Polyglycerol Polyricinoleate; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of polyglycerol polyricinoleate when used
as an inert ingredient in a pesticide chemical formulation. AgroFresh
Inc., submitted a petition to EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of polyglycerol polyricinoleate on food
or feed commodities.

DATES: This regulation is effective March 22, 2017. Objections and
requests for hearings must be received on or before May 22, 2017, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2016-0606, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2016-0606 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
May 22, 2017. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2016-0606, by one of
the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of December 20, 2016 (81 FR 927580) (FRL-
9956-04), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-
10970) filed by AgroFresh Inc., 400 Arcola Road, P.O. Box 7000
(RC3356), Collegeville, PA 19426. The petition requested that 40 CFR
180.960 be amended by establishing an exemption from the requirement of
a tolerance for residues of polyglycerol polyricinoleate (CAS Reg. No.
29894-35-7). That document included a summary of the petition prepared
by the petitioner and solicited comments on the petitioner's request.
The Agency did not receive any comments.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and use in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing an exemption from the
requirement of a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue . . .'' and
specifies

factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). Polyglycerol polyricinoleate conforms
to the definition of a polymer given in 40 CFR 723.250(b) and meets the
following criteria that are used to identify low-risk polymers:
    a. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
    b. The polymer does contain as an integral part of its composition
the atomic elements carbon, hydrogen, and oxygen.
    c. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
    d. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
    e. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
    f. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
    g. The polymer does not contain certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length as specified in
40 CFR 723.250(d)(6).
    Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
    h. The polymer's number average MW of 2,500 daltons is greater than
1,000 and less than 10,000 daltons. The polymer contains less than 10%
oligomeric material below MW 500 and less than 25% oligomeric material
below MW 1,000, and the polymer does not contain any reactive
functional groups.
    Thus, polyglycerol polyricinoleate meets the criteria for a polymer
to be considered low risk under 40 CFR 723.250. Based on its
conformance to the criteria in this unit, no mammalian toxicity is
anticipated from dietary, inhalation, or dermal exposure to
polyglycerol polyricinoleate.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this
exemption, EPA considered that polyglycerol polyricinoleate could be
present in all raw and processed agricultural commodities and drinking
water, and that non-occupational non-dietary exposure was possible. The
number average MW of polyglycerol polyricinoleate is 2,500 daltons.
Generally, a polymer of this size would be poorly absorbed through the
intact gastrointestinal tract or through intact human skin. Since
polyglycerol polyricinoleate conforms to the criteria that identify a
low-risk polymer, there are no concerns for risks associated with any
potential exposure scenarios that are reasonably foreseeable. The
Agency has determined that a tolerance is not necessary to protect the
public health.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not found polyglycerol polyricinoleate to share a common
mechanism of toxicity with any other substances, and polyglycerol
polyricinoleate does not appear to produce a toxic metabolite produced
by other substances. For the purposes of this tolerance action,
therefore, EPA has assumed that polyglycerol polyricinoleate does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of polyglycerol
polyricinoleate, EPA has not used a safety factor analysis to assess
the risk. For the same reasons the additional tenfold safety factor is
unnecessary.

VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of polyglycerol polyricinoleate.

VIII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint

United Nations Food and Agriculture Organization/World Health
Organization food standards program, and it is recognized as an
international food safety standards-setting organization in trade
agreements to which the United States is a party. EPA may establish a
tolerance that is different from a Codex MRL; however, FFDCA section
408(b)(4) requires that EPA explain the reasons for departing from the
Codex level.
    The Codex has not established a MRL for polyglycerol
polyricinoleate.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of polyglycerol
polyricinole from the requirement of a tolerance will be safe.

X. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

XI. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: February 16, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.960, add alphabetically the entry ``Polyglycerol
polyricinoleate; minimum number average molecular weight (in amu),
2,500'' to the table to read as follows:

Sec.  180.960   Polymers; exemptions from the requirement of a
tolerance.

* * * * *

------------------------------------------------------------------------
                         Polymer                              CAS No.
------------------------------------------------------------------------

                              * * * * * * *
Polyglycerol polyricinoleate; minimum number average          29894-35-7
 molecular weight (in amu), 2,500.......................

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2017-05703 Filed 3-21-17; 8:45 am]
 BILLING CODE 6560-50-P