[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Proposed Rules]
[Pages 46437-46443]
[FR Doc No: 2018-19864]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 20 and 720

[Docket No. FDA-2018-N-1622]
RIN 0910-AH69

Public Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
proposing to amend its public information regulations. The proposed
rule will revise the current regulations to incorporate changes made to
the Freedom of Information Act (FOIA) by the Openness Promotes
Effectiveness in our National Government Act of 2007 (OPEN Government
Act) and the FOIA Improvement Act of 2016 (FOIA Improvement Act).
Additionally, the proposed rule will update the current regulations to
reflect changes to the organization, to make the FOIA process easier
for the public to navigate, and to make provisions clearer.

DATES: Submit either electronic or written comments on this proposed
rule by November 13, 2018. See section VI of this document for the
proposed effective date of a final rule based on this document.

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 November 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 13, 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-2018-N-1622 for ``Public Information; Proposed Rule.'' Received
comments, those received 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: Sarah B. Kotler, Office of the
Commissioner, Office of the Executive Secretariat, Food and Drug
Administration, 5630 Fishers Lane, Rm. 1050, Rockville, MD 20857, 301-
796-3900, [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary

    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations and Acronyms Commonly Used Acronyms in
This Document
III. Background
IV. Legal Authority
V. Description of the Proposed Rule
VI. Proposed Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination with Indian Tribal Governments

I. Executive Summary

A. Purpose of the Proposed Rule

    FDA is proposing to amend FDA's public information regulations. The
regulations are being amended to incorporate changes made to FOIA by
the OPEN Government Act (Pub. L. 89-487) and the FOIA Improvement Act
(Pub. L. 114-185). Additionally, the proposed rule will update the
regulations to reflect changes to the organization, to make the FOIA
process easier for the public to navigate, and to make certain
provisions clearer. Taken together, these changes will enhance
transparency for the public with regard to FDA activities.

B. Summary of the Major Provisions of the Proposed Rule

    The proposed amendments to FDA's public information regulations
bring the Agency's regulations in line with statutory amendments to the
FOIA, update cross references to other statutes and parts of the
Agency's regulations, and clarify certain provisions with minor
editorial updates.

C. Legal Authority

    We are proposing these amendments based on our authority under FOIA
(5 U.S.C. 552) and section 701(a) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 371(a)). These proposed amendments
would allow FDA to more efficiently use our resources to provide
information to the public.

D. Costs and Benefits

    Although FDA is currently implementing the requirements of the OPEN
Government Act and the FOIA Improvement Act in FOIA processing as
standard practice, the requirements are not currently reflected in part
20 (21 CFR part 20). The revisions made by this proposed rule are
intended to incorporate all current FOIA requirements into the existing
regulations. Because the Agency has already adopted many of these
requirements, we anticipate no additional costs or benefits from this
rulemaking.

II. Table of Abbreviations and Acronyms Commonly Used in This Document

------------------------------------------------------------------------
          Abbreviation/Acronym                    What it means
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DFOI...................................  Division of Freedom of
                                          Information.
FOIA...................................  Freedom of Information Act.
FOIA Improvement Act...................  FOIA Improvement Act of 2016.
OGIS...................................  Office of Government
                                          Information Services.
OPEN Government Act....................  Openness Promotes Effectiveness
                                          in our National Government Act
                                          of 2007.
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III. Background

    The FOIA is a law that gives the public the right to access
information from the Federal government. There is a presumption that
government records must be released under FOIA unless they are subject
to one of nine FOIA exemptions. FDA's regulations for the
implementation of the FOIA are in part 20. The FOIA Improvement Act
specifically requires Agencies to review their FOIA regulations and
update their regulations for the disclosure of records in accordance
with its amendments.

IV. Legal Authority

    We are proposing these amendments based on our authority under FOIA
(5 U.S.C. 552) and section 701(a) of the FD&C Act (21 U.S.C. 371(a)).
These proposed amendments would allow FDA to more efficiently use our
resources to provide information to the public.

V. Description of the Proposed Rule

    We are proposing to amend provisions of part 20 regarding the
Agency's public information regulations. Once effective, the amendments
contained in the proposed rule would apply to all FOIA requests
currently pending with, or received in the future by, FDA.
     The proposed amendments to Sec.  20.20 would require FDA
to withhold information under the FOIA only if the Agency reasonably
foresees that disclosure would harm an interest protected by an
exemption or disclosure is prohibited by law. The proposed rule further
amends this provision to require FDA to establish procedures for
identifying records of general interest or use to the public that are
appropriate for public disclosure, and for posting such records in a
publicly accessible electronic format. These changes will promote
transparency by reducing the amount of information that will be
withheld when the Agency has discretion to determine what will be
withheld under the FOIA exemptions, and will make release of
information more efficient through the use of information technology.
These amendments are required by the FOIA Improvement Act, and are
currently part of FDA's FOIA policy and procedures.
     The proposed amendment to Sec.  20.22 would require FDA to
indicate the exemption(s) under which information has been deleted at
the site of the deletion. This change will inform requesters of the
legal bases under which information has been withheld from Agency
records, which promotes transparency. This change is required by the
OPEN Government Act and was adopted by the Agency for FOIA processing
as of the effective date of the OPEN Government Act.
     The proposed amendment to Sec.  20.26 would require FDA to
make available for public inspection in an electronic format records
that have been requested three or more times under the FOIA. This
change codifies the long-standing Department of Justice policy of
federal agencies posting records that have been requested three or more
times. The purpose of this change is to proactively release records to
the public without the need for submission of additional FOIA requests.
This change is required by the FOIA Improvement Act.
     The proposed amendment to Sec.  20.33 would require FDA to
offer the services of their FOIA Public Liaison and notify requesters
of the services provided by the Office of Government Information
Services (OGIS) when responding to FOIA requests. This change provides
requesters with additional avenues for resolving FOIA-related disputes
beyond the appeals process. This provision is required by the FOIA
Improvement Act.
     The proposed amendment to Sec.  20.40 updates the
provision to include reference to the Agency's online FOIA submission
portal, which has been online since June 2012.
     The proposed amendments to Sec.  20.41 would require that
when FDA extends the time limit to respond to requests by more than 10
additional working days, FDA must notify the requester of the right to
seek dispute resolution services from the FOIA Public Liaison and OGIS.
This change provides requesters with additional avenues for resolving
FOIA-related disputes beyond the appeals process.

We further amended the provision to provide that if a court determines
that exceptional circumstances exist, the Agency's failure to comply
with a time limit shall be excused for the length of time provided by
the court order. These changes are required by the FOIA Improvement
Act. The revised provision further clarifies that the Agency may toll
the response period once to seek more information from the requester,
and more than once (if necessary) to clarify fee assessments. This
revision is required by the OPEN Government Act.
     The proposed amendment to Sec.  20.44 updates the title of
the Agency official making determinations regarding requests for
expedited processing.
     The proposed amendments to Sec.  20.45 would modify the
fee schedule to prohibit the Agency from assessing fees if the Agency
fails to comply with time limits to respond and there are no unusual or
exceptional circumstances that apply to the processing of the request.
If unusual circumstances apply, these amendments establish a process by
which the Agency can work with the requester to effectively limit the
scope of the request. These changes will provide an incentive to the
Agency to process requests as efficiently as possible, and will provide
fee relief to requesters who do not receive FOIA responses in a timely
manner. These provisions are required by the OPEN Government Act.
Further amendments to this provision clarify how fees are calculated.
     The proposed rule amends Sec.  20.49(c) to require full
and partial denial letters to include contact information for the FOIA
Public Liaison and OGIS, and to increase the time for transmittal of an
appeal to 90 business days. We also made technical revisions to Sec.
20.49(a) to update the position title of the Agency FOIA Officer, and
to Sec.  20.49(c) to update the position title of the person to whom
appeals shall be addressed. These changes provide requesters with
additional avenues for resolving FOIA-related disputes beyond the
appeals process and provide requesters with additional time to decide
whether to pursue an appeal. These amendments are required by the FOIA
Improvement Act.
     The proposed rule amends Sec.  20.61(e)(2) to allow 10
days from the date of the notice for submitters of trade secrets or
confidential commercial information to object to disclosure. This
change will bring the Agency in line with departmental regulations.
     The proposed rule amends Sec.  20.62 to prohibit the
application of the deliberative process privilege of Exemption 5 of the
FOIA to records created 25 years or more before the date on which the
records were requested. This change will increase transparency by
requiring the Agency to release information that could otherwise fall
within the deliberative process privilege of the Exemption. This
amendment is required by the FOIA Improvement Act.
     The amendment to Sec.  20.82 clarifies that the
discretionary disclosure standard outlined in that provision will guide
the Agency's determinations of whether the Agency reasonably foresees
that a disclosure of information would harm an interest protected by an
exemption or disclosure is prohibited by law as required in
administering Sec.  20.20.
     The amendment to Sec.  20.85 updates the statutory
references.
     The amendment to Sec.  20.86 clarifies that the list of
proceedings subject to the provision is not exclusive.
     The amendments to Sec.  20.88 clarify that the provisions
also apply to local officials and remove references to position titles
that no longer exist.
     The amendments to Sec.  20.89 remove references to
position titles that no longer exist.
     The amendments to Sec.  20.100 update the regulatory
cross-references.
     The amendment to Sec.  20.120 updates the contact
information for the Agency's reading rooms.
     The amendment to 21 CFR 720.8 revises the request for
confidentiality of the identity of a cosmetic ingredient provision for
consistency with FDA's disclosure regulation at Sec.  20.29.

VI. Proposed Effective Date

    FDA proposes that any final rule that issues based on this proposal
become effective 30 days after the final rule publishes in the Federal
Register.

VII. Preliminary Economic Analysis of Impacts

    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 the proposed revisions do not impose any burdens upon
FOIA requesters, including those that might be small entities, 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 $150 million, using the most current (2017) 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.
    We expect to incur negligible costs associated with implementing
this rule. These costs result from updating titles of Agency officials,
providing some additional information to FOIA requesters, and compiling
information for annual reports. These requirements would not require
more resources from us because we would perform these actions as part
of our routine practices for FOIA processing. The proposed rule, if
finalized, would enhance public access to government information as
required by the FOIA Improvement Act.

VIII. 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.

IX. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by OMB under the
Paperwork Reduction Act of 1995 is not required.

X. 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 proposed 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.

XI. 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
concluded 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. Accordingly, we conclude that a tribalism
summary impact statement is not required.

List of Subjects

21 CFR Part 20

    Confidential business information, Courts, Freedom of information,
Government employees.

21 CFR Part 720

    Confidential business information, Cosmetics.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, we propose
that 21 CFR parts 20 and 720 be amended as follows:

PART 20--PUBLIC INFORMATION

0
1. The authority citation for part 20 continues to read as follows:

    Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21
U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n,
243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.

0
2. Revise Sec.  20.20 to read as follows:

Sec.  20.20  Policy on disclosure of Food and Drug Administration
records.

    (a) The Food and Drug Administration (FDA) will make the fullest
possible disclosure of records to the public, consistent with the
rights of individuals to privacy, the property rights of persons in
trade secrets and confidential commercial or financial information, and
the need for the Agency to promote frank internal policy deliberations
and to pursue its regulatory activities without disruption.
    (b) Except where specifically exempt pursuant to the provisions of
this part, all FDA records shall be made available for public
disclosure. FDA will make discretionary disclosures of records or
information exempt from disclosure under the provisions of this part
whenever disclosure would not foreseeably harm an interest protected by
an exemption pursuant to this part. This provision does not require
disclosure of information that is prohibited from disclosure by law.
    (c) In accordance with the FOIA Improvement Act of 2016 (Pub. L.
114-185), FDA will establish procedures for identifying records of
general interest or use to the public that are appropriate for public
disclosure, and for posting and indexing such records in a publicly
accessible electronic format.
    (d) Except as provided in paragraph (e) of this section, all
nonexempt records shall be made available for public disclosure upon
request regardless of whether any justification or need for such
records have been shown.
    (e) ``Record'' and any other term used in this section in reference
to information includes any information that would be an Agency record
subject to the requirements of this part when maintained by the Agency
in any format, including an electronic format.
0
3. In Sec.  20.22, add paragraph (b)(3) to read as follows:

Sec.  20.22  Partial disclosure of records.

* * * * *
    (b) * * *
    (3) The exemption(s) under which the information has been deleted
shall be noted at the site of the deletion.
0
4. In Sec.  20.26, revise the section heading and paragraph (a)(4) to
read as follows:

Sec.  20.26   Electronic availability and indexes of certain records.

    (a) * * *
    (4) Records that have been released to any person in response to a
Freedom of Information request and that the Agency has determined have
become, or are likely to become, the subject of subsequent requests for
substantially the same records or that have been requested three or
more times.
* * * * *
0
5. In Sec.  20.33, add paragraph (c) to read as follows:

Sec.  20.33  Form or format of response.

* * * * *
    (c) Response letters shall contain contact information for the FOIA
Public Liaison and the Office of Government Information Services as
required by the FOIA Improvement Act of 2016 (Pub. L. 114-185).
0
6. In Sec.  20.40, revise paragraph (a) to read as follows:

Sec.  20.40   Filing a request for records.

    (a) All requests for Food and Drug Administration records shall be
made in writing by mailing or delivering the request to the Freedom of
Information Staff at the address on the Agency's website at https://www.fda.gov or by faxing it to the fax number listed on the Agency's
website at https://www.fda.gov, or by submission through the Agency's
online FOIA submission portal at https://www.fda.gov. All requests must
contain the postal address and telephone number of the requester and
the name of the person responsible for payment of any fees that may be
charged.
* * * * *
0
7. In Sec.  20.41, revise paragraphs (b)(3)(i)(A) and (b)(4), and add
paragraphs (b)(5) and (d) to read as follows:

Sec.  20.41   Time limitations.

* * * * *
    (b) * * *
    (3)(i) * * *
    (A) The Agency may provide for an extension of up to 10 working
days by providing written notice to the requester setting out the
reasons for the extension and the date by which a determination is
expected to be sent. In the written notice, the Agency will inform the
requester of the right to contact the Freedom of Information Act Public
Liaison and to seek dispute resolution services from the Office of
Government Information Services.
* * * * *
    (4) The Agency may contact the requester for clarification about
the request or regarding fee assessment. The Agency may toll the 20-day
period as follows:
    (i) One time while it is awaiting a response from the requester
regarding clarification that it has reasonably requested from the
requester; and
    (ii) One or more times while the Agency is awaiting a response from
the requester regarding fee assessment.
    (5) If any record is denied, the letter shall state the right of
the person requesting such records to appeal any

adverse determination to the Deputy Agency Chief Freedom of Information
Act Officer, Department of Health and Human Services, in accordance
with the provisions of 45 CFR 5.62.
* * * * *
    (d) If a court determines that exceptional circumstances exist, as
defined by the Freedom of Information Act, the Agency's failure to
comply with a time limit shall be excused for the length of time
provided by the court order.
0
8. In Sec.  20.44, revise paragraph (e) to read as follows:

Sec.  20.44  Expedited processing.

* * * * *
    (e) The Director, Division of Freedom of Information, (or
Delegatee) will determine whether to grant a request for expedited
processing within 10 days of receipt by the Division of Freedom of
Information of all information required to make a decision.
* * * * *
0
9. In Sec.  20.45, revise paragraphs (a)(1) through (3), add paragraph
(b)(7), and revise paragraphs (c)(1) and (2) to read as follows:

Sec.  20.45  Fees to be charged.

    (a) * * *
    (1) Commercial use request. If the request is for a commercial use,
the Food and Drug Administration will charge for the costs of search,
review, and duplication. The Agency shall not assess search fees if the
Agency fails to comply with any time limit, as described in Sec.
20.41, if no unusual or exceptional circumstances apply to the
processing of the request. If unusual circumstances, as outlined in
Sec.  20.41, apply and more than 5,000 pages are necessary to respond
to the request, the Food and Drug Administration may charge search fees
if timely written notice has been made to the requester and the Agency
has discussed with the requester via written mail, electronic mail, or
telephone (or made not less than three good-faith attempts to do so)
how the requester could effectively limit the scope of the request.
    (2) Educational and scientific institutions and news media. If the
request is from an educational institution or a noncommercial
scientific institution, operated primarily for scholarly or scientific
research, or a representative of the news media, and the request is not
for a commercial use, the Food and Drug Administration will charge only
for the duplication of documents. Also, the Food and Drug
Administration will not charge the copying costs for the first 100
pages of duplication (or its cost equivalent of other media). The
Agency shall not assess duplication fees if the Agency fails to comply
with any time limit, as described in Sec.  20.41, if no unusual or
exceptional circumstances apply to the processing of the request. If
unusual circumstances, as outlined in Sec.  20.41, apply and more than
5,000 pages are necessary to respond to the request, the Food and Drug
Administration may charge duplication fees if timely written notice has
been made to the requester and the Agency has discussed with the
requester via written mail, electronic mail, or telephone (or made not
less than three good-faith attempts to do so) how the requester could
effectively limit the scope of the request.
    (3) Other requests. If the request is not the kind described in
paragraph (a)(1) or (2) of this section, then the Food and Drug
Administration will charge only for the search and the duplication.
Also, the Food and Drug Administration will not charge for the first 2
hours of search time or for the copying costs of the first 100 pages of
duplication (or the cost equivalent of other media). The Agency shall
not assess search fees if the Agency fails to comply with any time
limit, as described in Sec.  20.41, if no unusual or exceptional
circumstances apply to the processing of the request. If unusual
circumstances, as outlined in Sec.  20.41, apply and more than 5,000
pages are necessary to respond to the request, the Food and Drug
Administration may charge search fees if timely written notice has been
made to the requester and the Agency has discussed with the requester
via written mail, electronic mail, or telephone (or made not less than
three good-faith attempts to do so) how the requester could effectively
limit the scope of the request.
* * * * *
    (b) * * *
    (7) Requesters may contact Agency Freedom of Information Act staff
or the Freedom of Information Act Public Liaison to assist in
reformulating a request to meet their needs at lower cost.
* * * * *
    (c) * * *
    (1) Manual searching for or reviewing of records. When the search
or review is performed by employees at grade GS-1 through GS-8 (or
equivalent), an hourly rate based on the salary of a GS-5, step 7,
employee; when done by a GS-9 through GS-14 (or equivalent), an hourly
rate based on the salary of a GS-12, step 4, employee; and when done by
a GS-15 or above (or equivalent), an hourly rate based on the salary of
a GS-15, step 7, employee. In each case, the hourly rate will be
computed by taking the current hourly rate for the specified grade and
step in the General Schedule Locality Pay Table for the Locality of
Washington-Baltimore-Northern Virginia, DC-MD-VA-WV-PA, adding 16
percent of that rate to cover benefits, and rounding to the nearest
whole dollar. When a search involves employees at more than one of
these levels, the Food and Drug Administration will charge the rate
appropriate for each.
    (2) Electronic searching. Charges for the time spent by the
operator to search the computer, database or network, including
development of any specialized programming required to perform the
search, at the rate given in paragraph (c)(1) of this section plus the
cost of any materials.
* * * * *
0
10. In Sec.  20.49, revise paragraphs (a) and (c) and remove paragraph
(d).
    The revisions read as follows:

Sec.  20.49  Denial of a request for records.

    (a) A denial of a request for records, in whole or in part, shall
be signed by the Director, Division of Freedom of Information, or other
official who has been delegated the authority to release or withhold
records.
* * * * *
    (c) A letter denying a request for records, in whole or in part,
shall state the reasons for the denial and shall state that an appeal
may be transmitted to the Deputy Agency Chief Freedom of Information
Act Officer, Department of Health and Human Services, within 90
calendar days from the date of the adverse determination, in accordance
with 45 CFR 5.61. The Agency will also make a reasonable effort to
include in the letter an estimate of the volume of the records denied,
unless providing such an estimate would harm an interest protected by
an exemption under the Freedom of Information Act. This estimate will
ordinarily be provided in terms of the approximate number of pages or
some other reasonable measure. This estimate will not be provided if
the volume of records denied is otherwise indicated through deletions
on records disclosed in part. The letter will also include contact
information for the Freedom of Information Act Public Liaison and the
Office of Government Information Services.
0
11. In Sec.  20.61, revise paragraph (e)(2) to read as follows:

Sec.  20.61  Trade secrets and commercial or financial information
which is privileged or confidential.

* * * * *
    (e) * * *

    (2) The submitter has 10 working days from the date of the notice
to object to disclosure of any part of the records and to state all
bases for its objections. Division of Freedom of Information may extend
this period as appropriate and necessary.
* * * * *
0
12. Revise Sec.  20.62 to read as follows:

Sec.  20.62  Inter- or intra-agency memoranda or letters.

    Inter-agency or intra-agency memoranda or letters that would not be
available by law to a party other than an Agency in litigation with the
Food and Drug Administration may be withheld from public disclosure
except that factual information that is reasonably segregable in
accordance with the rule established in Sec.  20.22 is available for
public disclosure. The deliberative process privilege shall not apply
to records created 25 years or more before the date on which the
records were requested.
0
13. In Sec.  20.82, revise paragraph (a) to read as follows:

Sec.  20.82   Discretionary disclosure by the Commissioner.

    (a) Except as provided in paragraph (b) of this section, the
Commissioner may, in his or her discretion, disclose part or all of any
Food and Drug Administration (FDA) record that is otherwise exempt from
disclosure pursuant to subpart D of this part. As set forth in Sec.
20.20(b) FDA shall make discretionary disclosures of records or
information exempt from disclosure under the provisions of this part
whenever disclosure would not foreseeably harm an interest protected by
an exemption pursuant to this part. Specifically, FDA shall exercise
its discretion to disclose such records whenever it determines that
such disclosure is in the public interest, will promote the objectives
of the Freedom of Information Act and the Agency, and is consistent
with the rights of individuals to privacy, the property rights of
persons in trade secrets, and the need for the Agency to promote frank
internal policy deliberations and to pursue its regulatory activities
without disruption.
* * * * *
0
14. Revise Sec.  20.85 to read as follows:

Sec.  20.85  Disclosure to other Federal government departments and
agencies.

    Any Food and Drug Administration (FDA) record otherwise exempt from
public disclosure may be disclosed to other Federal government
departments and agencies, except that trade secrets and confidential
commercial or financial information prohibited from disclosure by 21
U.S.C. 331(j), 21 U.S.C. 360j(c), 21 U.S.C. 360ll(d), 21 U.S.C.
360nn(e) and 21 U.S.C. 387f(c) may be released only as provided by
those sections. Any disclosure under this section shall be pursuant to
a written agreement that the record shall not be further disclosed by
the other department or Agency except with the written permission of
the FDA.
0
15. Revise Sec.  20.86 to read as follows:

Sec.  20.86  Disclosure in administrative or court proceedings.

    Data and information otherwise exempt from public disclosure may be
revealed in Food and Drug Administration (FDA) administrative
proceedings, such as those pursuant to parts 10, 12, 13, 14, 15, 17,
and 19 of this chapter or court proceedings, where data or information
are relevant. The FDA will take appropriate measures, or request that
appropriate measures be taken, to reduce disclosure to the minimum
necessary under the circumstances.
0
16. In Sec.  20.88, revise paragraphs (d)(1) introductory text,
(d)(1)(i), (d)(1)(ii)(B) and (C), (d)(2), and (e)(1) and (3) to read as
follows:

Sec.  20.88  Communications with State and local government officials.

* * * * *
    (d)(1) The Commissioner of Food and Drugs, or any other officer or
employee of the Food and Drug Administration whom the Commissioner may
designate to act on his or her behalf for the purpose, may authorize
the disclosure of confidential commercial information submitted to the
Food and Drug Administration, or incorporated into Agency-prepared
records, to State and local government officials as part of cooperative
law enforcement or regulatory efforts, provided that:
    (i) The State or local government agency has provided both a
written statement establishing its authority to protect confidential
commercial information from public disclosure and a written commitment
not to disclose any such information provided without the written
permission of the sponsor or written confirmation by the Food and Drug
Administration that the information no longer has confidential status;
and
    (ii) * * *
    (B) Disclosure would be in the interest of public health by reason
of the State or local government's possessing information concerning
the safety, effectiveness, or quality of a product or information
concerning an investigation, or by reason of the State or local
government being able to exercise its regulatory authority more
expeditiously than the Food and Drug Administration; or
    (C) The disclosure is to a State or local government scientist
visiting the Food and Drug Administration on the Agency's premises as
part of a joint review or long-term cooperative training effort
authorized under section 708 of the Federal Food, Drug, and Cosmetic
Act, the review is in the interest of public health, the Food and Drug
Administration retains physical control over the information, the Food
and Drug Administration requires the visiting State or local government
scientist to sign a written commitment to protect the confidentiality
of the information, and the visiting State or local government
scientist provides a written assurance that he or she has no financial
interest in the regulated industry of the type that would preclude
participation in the review of the matter if the individual were
subject to the conflict of interest rules applicable to the Food and
Drug Administration advisory committee members under Sec.  14.80(b)(1)
of this chapter. Subject to all the foregoing conditions, a visiting
State or local government scientist may have access to trade secret
information, entitled to protection under section 301(j) of the Federal
Food, Drug, and Cosmetic Act, in those cases where such disclosures
would be a necessary part of the joint review or training.
    (2) Except as provided under paragraph (d)(1)(ii)(C) of this
section, this provision does not authorize the disclosure to State and
local government officials of trade secret information concerning
manufacturing methods and processes prohibited from disclosure by
section 301(j) of the Federal Food, Drug, and Cosmetic Act, unless
pursuant to an express written authorization provided by the submitter
of the information.
* * * * *
    (e)(1) The Commissioner of Food and Drugs, or any other officer or
employee of the Food and Drug Administration whom the Commissioner may
designate to act on his or her behalf for the purpose, may authorize
the disclosure to, or receipt from, an official of a State or local
government agency of nonpublic, predecisional documents concerning the
Food and Drug Administration's or the other government agency's
regulations or other regulatory requirements, or other nonpublic
information relevant to either agency's activities, as part of efforts
to improve Federal-State and/or Federal-local uniformity, cooperative
regulatory activities, or implementation of Federal-

State and/or Federal-local agreements, provided that:
    (i) The State or local government agency has the authority to
protect such nonpublic documents from public disclosure and will not
disclose any such documents provided without the written confirmation
by the Food and Drug Administration that the documents no longer have
nonpublic status; and
    (ii) The Commissioner or his or her designee makes the
determination that the exchange is reasonably necessary to improve
Federal-State and/or Federal-local uniformity, cooperative regulatory
activities, or implementation of Federal-State and/or Federal-local
agreements.
* * * * *
    (3) For purposes of this paragraph, the term official of a State or
local government agency includes, but is not limited to, an agent
contracted by the State or local government, and an employee of an
organization of State or local officials having responsibility to
facilitate harmonization of State or local standards and requirements
in the Food and Drug Administration's areas of responsibility. For such
officials, the statement and commitment required by paragraph (e)(1)(i)
of this section shall be provided by both the organization and the
individual.
0
17. In Sec.  20.89, revise paragraph (d) to read as follows:

Sec.  20.89  Communications with foreign government officials.

* * * * *
    (d)(1) The Commissioner of Food and Drugs, or any other officer or
employee of the Food and Drug Administration whom the Commissioner may
designate to act on his or her behalf for the purpose, may authorize
the disclosure to, or receipt from, an official of a foreign government
agency of nonpublic, predecisional documents concerning the Food and
Drug Administration's or the other government agency's regulations or
other regulatory requirements, or other nonpublic information relevant
to either agency's activities, as part of cooperative efforts to
facilitate global harmonization of regulatory requirements, cooperative
regulatory activities, or implementation of international agreements,
provided that:
    (i) The foreign government agency has the authority to protect such
nonpublic documents from public disclosure and will not disclose any
such documents provided without the written confirmation by the Food
and Drug Administration that the documents no longer have nonpublic
status; and
    (ii) The Commissioner or his or her designee makes the
determination that the exchange is reasonably necessary to facilitate
global harmonization of regulatory requirements, cooperative regulatory
activities, or implementation of international agreements.
    (2) Any exchange under this section of nonpublic documents does not
invoke the rule established in Sec.  20.21 that such records shall be
made available to all members of the public.
* * * * *
0
18. In Sec.  20.100, revise paragraph (c)(6), remove and reserve
paragraphs (c)(20) and (21), and add paragraphs (c)(47) through (51).
    The revision and additions read as follows:

Sec.  20.100  Applicability; cross-reference to other regulations.

* * * * *
    (c) * * *
    (6) Information on thermal processing of low-acid foods packaged in
hermetically sealed containers, in Sec. Sec.  108.25(k) and 108.35(l)
of this chapter.
* * * * *
    (47) Status reports of postmarketing study commitments in
Sec. Sec.  314.81(b)(2)(vii)(b) and 601.70(e) of this chapter.
    (48) Postmarket notification relating to shortages in Sec.  600.82
of this chapter.
    (49) Postmarket notification relating to shortages in Sec. Sec.
310.306 and 314.81 of this chapter.
    (50) Minor Species/Minor Use designation, in Sec.  516.52 of this
chapter.
    (51) Minor Species drug index listing, in Sec.  516.171 of this
chapter.
0
19. In Sec.  20.120, revise paragraph (a) to read as follows: Sec.
20.120 Records available in Food and Drug Administration Public Reading
Rooms.
    (a) The Freedom of Information Staff and the Dockets Management
Staff Public Reading Room are located at the same address. Both are
located in Rm. 1061, 5630 Fishers Lane, Rockville, MD 20852. The
telephone number for the Docket Management Staff is<PHONE_NUMBER>; the
telephone number for the Freedom of Information Staff's Public Reading
Room is located at the address on the Agency's website at https://www.fda.gov. Both public reading rooms are open from 9 a.m. to 4 p.m.,
Monday through Friday, excluding legal public holidays.
* * * * *

PART 720--VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT
COMPOSITION STATEMENTS

0
20. The authority citation for part 720 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 361, 362, 371, 374.

0
21. In Sec.  720.8, revise paragraphs (e) and (g) to read as follows:

Sec.  720.8  Confidentiality of statements.

* * * * *
    (e) If, after receiving all of the data that are necessary to make
a determination about whether the identity of an ingredient is a trade
secret, FDA tentatively decides to deny the request, the Agency will
inform the person requesting trade secrecy of its tentative
determination in writing. FDA will set forth the grounds upon which it
relied in making this tentative determination. The petitioner may
submit, within 60 days from the date of receipt of the written notice
of the tentative denial, additional relevant information and arguments
and request that the Agency reconsider its decision in light of both
the additional material and the information that it originally
submitted.
* * * * *
    (g) A final determination that an ingredient is not a trade secret
within the meaning of Sec.  20.61 of this chapter constitutes final
Agency action that is subject to judicial review under 5 U.S.C. Chapter
7. If suit is brought within 30 calendar days after such a
determination, FDA will not disclose the records involved or require
that the disputed ingredient or ingredients be disclosed in labeling
until the matter is finally determined in the courts. If suit is not
brought within 30 calendar days after a final determination that an
ingredient is not a trade secret within the meaning of Sec.  20.61 of
this chapter, the records involved will be available for public
disclosure in accordance with part 20 of this chapter.

    Dated: September 7, 2018.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2018-19864 Filed 9-12-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 23 (Thursday, February 3, 2011)]
[Notices]
[Pages 6128-6129]
[FR Doc No: 2011-2346]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER11-2730-000]

Energy Exchange International, LLC; Supplemental Notice That
Initial Market-Based Rate Filing Includes Request for Blanket Section
204 Authorization

January 27, 2011.
    This is a supplemental notice in the above-referenced proceeding
Energy Exchange International, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is February 16, 2011.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access

who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-2346 Filed 2-2-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 247 (Friday, December 23, 2016)]
[Notices]
[Pages 94364-94365]
[FR Doc No: 2016-30978]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-569-000]

National Choice Energy LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
National Choice Energy LLC`s application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is January 9, 2017.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the

Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY,
call<PHONE_NUMBER>.

    Dated: December 19, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-30978 Filed 12-22-16; 8:45 am]
BILLING CODE 6717-01-P


Final minutes August 11 Teleconference September 25, 2003 Page 1 of 3 Minutes Registration Review Workgroup Pesticide Program Dialogue Committee August 11, 2003 Teleconference Participants: EPA: Betty Shackleford, Richard Dumas, Michael Nieves, Philip Ross, Tim Kiely, Teresa Downs, Ingrid Sunzenauer, and Vivian Prunier Work Group Members: Britt Bailey, Cindy Baker, Steve Kellner, Therese Murtagh, Steve Rutz, Julie Spagnoli, Roberta Spitko, Janine Rynczak ( substituting for Warren Stickle), and Ray McAllister Minutes of July 16 Meeting. In addition to editorial changes, the date of the next face to face meeting was corrected. The meeting will be held on October 28, the day before the PPDC meeting and not on October 16 as announced at the meeting and stated in the draft minutes. It was agreed that the October 16 date would be reserved for a teleconference if necessary.

Criteria for Scheduling Registration Review. The workgroup participants agreed with the finding in the draft paper that the most logical basis for scheduling registration review was the date of the initial registration or the reregistration eligibility decision. Participants said that they needed a predictable schedule and an orderly process. Workgroup members agreed to revise the paper in time for the next teleconference.

Scope of Registration Review. EPA asked the Workgroup to clarify its suggestion that registration review does not include inert ingredients. FIFRA section 3( g) states that the registrations of pesticides shall be periodically reviewed. Pesticide registrations include all the ingredients in a pesticide   active and inert. Accordingly, the Agency believes that registration review must account for inert ingredients. The Agency is trying to develop approaches to accomplish the review of all pesticide registrations, including inert ingredients, and asks the Workgroup's help on this issue.

What is a Registration Review Decision? All participants agreed that the purpose of a registration review was to determine whether a pesticide meets the requirements of FIFRA section 3( c)( 5). Among other things, FIFRA section 3( c)( 5) specifies that use of the pesticide will not cause unreasonable adverse effects on the environment. Under the definition of " unreasonable adverse effects" in FIFRA section 2( bb), EPA must consider, among other things, whether human dietary exposures to a pesticide meet the safety standard established in section 408 of the Federal Food, Drug and Cosmetic Act.

The participants discussed whether the Agency could conclude that a pesticide's registration met the requirements of FIFRA section 3( c)( 5) if additional data are necessary for a Final minutes August 11 Teleconference September 25, 2003 Page 2 of 3 registration review. The Agency reminded the Workgroup that FIFRA section 3( g)( 2)( A) states that the Agency shall require submission of data that are necessary for a registration review. EPA interprets this provision to mean that the registration review cannot be completed until examination of the new data deemed necessary for a registration review shows that the pesticide continues to meet the requirements of FIFRA section 3( c)( 5).

Workgroup members proposed that a registration review could find that a pesticide registration was in compliance with FIFRA requirements, including any requirement to submit data necessary for a registration review, and suggested that a decision as to whether the pesticide meets the requirements of FIFRA section 3( c)( 5) could be postponed until the data have been submitted and examined. EPA agreed that under some circumstances, a registration review decision could acknowledge pending data that were called in under a special data call in. The review of these data could be separate from the registration review of the pesticide.

Workgroup members suggested that EPA call in studies as soon as the Agency recognizes a need for data on a chemical or on a group of chemicals that share common attributes. This way the studies would be available for the pesticide's registration review and the review could be completed on schedule.

Workgroup members suggested that registration review should not include a DCI for data requirements that have not been codified in Part 158 of 40 CFR. Such requests for data should be made in special DCI projects. EPA acknowledged that it might be difficult for registrants to prepare for a registration review when there is uncertainty about what information will be needed to support continued registration of the pesticide. If the Agency finds that additional data are necessary for the registration review, it would require submission of such data, even if the data requirement has not been codified in 40 CFR Part 158.

Deciding on the Level of Assessment. EPA asked the workgroup to consider ways in which the registration review process could avoid the " one size fits all" approach that the Agency used in the reregistration program.

Workgroup members suggested that the Agency ask three questions to gauge the level of assessment: 1) have requirements changed since the last review? 2) has anything new happened, e. g., new uses, new hazard information, new alternatives 3) have risk assessment methods or policy changed since the last review? If the answer to all these questions is " no," the registration review would be essentially complete. If the answer to one or more of these questions is " yes," the Agency should consult with stakeholders to see whether the risk assessment should be refined or if risk mitigation measures should be considered.

Betty asked the Workgroup to consider additional criteria for assessing the level of assessment and suggested that members review OPP's proposed approach for registration review ( i. e., the material presented to the PPDC in April). Final minutes August 11 Teleconference September 25, 2003 Page 3 of 3 Action Items ° EPA to send meeting notes to workgroup members within a week. ° Workgroup members to revise the " Scope" paper and the " Scheduling Criteria" paper before the next meeting. ° EPA to clarify its position on the inclusion of inert ingredients in registration review ( completed; see page 1, paragraph 3 of these meeting notes). ° EPA to provide a list of active ingredients that shows the date of the last major action. ° Cindy Baker, Julie Spagnoli, Therese Murtagh and Steve Kellner will draft a paper on " deciding the level of assessment" by September 12.

Agenda for September 24 Teleconference ° Complete discussion of " deciding levels of assessment." ° Begin discussion of stakeholder involvement in the registration review process.


[Federal Register Volume 82, Number 60 (Thursday, March 30, 2017)]
[Proposed Rules]
[Pages 15660-15662]
[FR Doc No: 2017-06262]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2017-0169]
RIN 1625-AA08

Special Local Regulation; Washburn Board Across the Bay, Lake
Superior; Chequamegon Bay, WI

AGENCY: Coast Guard, DHS.

ACTION: Notice of Proposed Rulemaking.

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

SUMMARY: The Coast Guard proposes to establish a permanent special
local regulation on Lake Superior within Chequamegon Bay for the annual
Washburn Board Across the Bay racing event. This annual event
historically occurs within the last 2 weeks of July and lasts for 1
day. This action is necessary to safeguard the participants and
spectators on the water in a portion of Chequamegon Bay between
Washburn, WI and Ashland, WI. This regulation would functionally
restrict all vessel speeds while within a designated no-wake zone,
unless otherwise specifically authorized by the Captain of the Port
(COTP) Duluth or a designated representative. The area forming the
subject of this permanent special local regulation is described below.
We invite your comments on this notice of proposed rulemaking (NPRM).

DATES: Comments and related material must be received by the Coast
Guard on or before May 1, 2017.

ADDRESSES: You may submit comments identified by docket number USCG-
USCG-2017-0169 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Lieutenant Junior Grade John Mack,
Waterways management, MSU Duluth, Coast Guard; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

COTP Captain of the Port, Duluth
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    This annual event will consist of a series of races of varying
lengths that utilize stand up paddleboards, sea kayaks, and canoes and
will take place in Lake Superior within Chequamegon Bay between
Washburn, WI and Ashland, WI. Due to the race course spanning across
the entire bay it is anticipated that a significant number of
recreational and commercial vessels attempting to transit across the
course would pose a significant safety hazard to race participants and
safety observers.
    The Captain of the Port, Duluth, believes a permanent special local
regulation for Chequamegon Bay is needed to restrict the speed of
vessels through the use of a no-wake zone within Chequamegon Bay
before, during, and after the scheduled event to safeguard persons and
vessels during the races. The statutory basis for this rulemaking is 33
U.S.C. 1233, which give the Coast Guard, under a delegation from the
Department of Homeland Security, regulatory authority to enforce the
Ports and Waterways Safety Act.

III. Discussion of Proposed Rule

    This proposed rule would create a permanent special local
regulation in Chequamegon Bay for the annual Washburn Board Across the
Bay racing event that historically takes place in the third or fourth
week of July. The no-wake zone would be enforced on all vessels
entering into 100 yards of either side of an imaginary line beginning
in Washburn, WI at position 46[deg]36'52'' N., 090[deg]54'24'' W.;
thence southwest to position 46[deg]38'44'' N., 090[deg]54'50'' W.;
thence southeast to position 46[deg]37'02'' N., 090[deg]50'20'' W.; and
ending southwest at position 46[deg]36'12'' N., 090[deg]51'51'' W. All
vessels transiting through the no-wake zone would be required to travel
at an appropriate rate of speed that does not create a wake except as
may be permitted by the COTP or a designated representative. The
precise times and date of enforcement for this special local regulation
will be determined annually.
    The Captain of the Port, Duluth, would use all appropriate means to
notify the public when the special local

regulation in this proposed rule will be enforced. Such means may
include publication in the Federal Register a Notice of Enforcement,
Broadcast Notice to Mariners, and Local Notice to Mariners. The
proposed regulatory text appears at the end of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    E.O.s 12866 (``Regulatory Planning and Review'') and 13563
(``Improving Regulation and Regulatory Review'') direct agencies to
assess the costs and benefits of available regulatory alternatives and,
if regulation is necessary, to select regulatory approaches that
maximize net benefits including potential economic, environmental,
public health and safety effects, distributive impacts, and equity.
E.O. 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. Executive Order 13771 (``Reducing Regulation and
Controlling Regulatory Costs''), directs agencies to reduce regulation
and control regulatory costs and provides that ``for every one new
regulation issued, at least two prior regulations be identified for
elimination, and that the cost of planned regulations be prudently
managed and controlled through a budgeting process.''
    The Office of Management and Budget (OMB) has not designated this
rule a significant regulatory action under section 3(f) of Executive
Order 12866. Accordingly, the Office of Management and Budget (OMB) has
not reviewed it.
    As this rule is not a significant regulatory action, this rule is
exempt from the requirements of Executive Order 13771. See OMB's
Memorandum titled ``Interim Guidance Implementing Section 2 of the
Executive Order of January 30, 2017 titled `Reducing Regulation and
Controlling Regulatory Costs' '' (February 2, 2017).
    This regulatory action determination is based on the size,
location, duration, and time-of-year of the Special Local Regulation.
Vessel traffic will be able to safely transit through the no-wake zone
which will be 200 yards wide and will impact only a small designated
area of Lake Superior in Chequamegon Bay between Washburn, WI and
Ashland, WI during a time of year when commercial vessel traffic is
normally low. Moreover, the Coast Guard will issue Broadcast Notice to
Mariners via VHF-FM marine channel 16.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit
through the no-wake zone may be small entities, for the reasons stated
in section V.A above, this proposed rule would not have a significant
economic impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the proposed rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact the person listed in the FOR
FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate
against small entities that question or complain about this proposed
rule or any policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule will not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would 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. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. 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 (adjusted for
inflation) or more in any one year. Though this proposed rule will not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed 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 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a no-wake
zone being enforced for no more than 5 hours along a prescribed route
between Washburn & Ashland, Wisconsin. Normally such actions are
categorically excluded from further review under paragraph 34(h) of
Figure 2-1 of Commandant Instruction M16475.lD. A preliminary
environmental analysis checklist and Categorical Exclusion
Determination are available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 100

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

    For the reasons discussed in the preamble, the Coast Guard proposed
to amend 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. Add Sec.  100.0169 to read as follows:

Sec.  100.0169  Special Local Regulation; Washburn Board Across the
Bay, Lake Superior; Chequamegon Bay, WI.

    (a) Location. All waters of Chequamegon Bay within 100 yards of
either side of an imaginary line beginning in Washburn, WI at position
46[deg]36'52'' N., 090[deg]54'24'' W.; thence southwest to position
46[deg]38'44'' N., 090[deg]54'50'' W.; thence southeast to position
46[deg]37'02'' N., 090[deg]50'20'' W.; and ending southwest at position
46[deg]36'12'' N., 090[deg]51'51'' W.
    (b) Effective period. This annual event historically occurs within
the third or fourth week of July. The Captain of the Port Duluth, will
establish enforcement dates that will be announced by Notice of
Enforcement, Local Notice to Mariners, Broadcast Notice to Mariners,
on-scene designated representatives, or other forms of outreach.
    (c) Regulations. Vessels transiting within the regulated area shall
travel at a no-wake speed except as may be permitted by the Captain of
the Port Duluth or a designated on-scene representative. Additionally,
vessels shall yield right-of-way for event participants and event
safety craft and shall follow directions given by event representatives
during the event.
    (d) Penalties. Vessels or persons violating this rule may be
subject to the penalties set forth in 33 U.S.C. 1233.

    Dated: March 23, 2017.
E.E. Williams,
Commander, U.S. Coast Guard, Captain of the Port Duluth.
[FR Doc. 2017-06262 Filed 3-29-17; 8:45 am]
 BILLING CODE 9110-04-P