[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Notices]
[Pages 5795-5796]
[FR Doc No: 2016-01931]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76995; File No. SR-C2-2016-001]

Self-Regulatory Organizations; C2 Options Exchange, Incorporated;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to the Options Regulatory Fee

January 28, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 14, 2016, C2 Options Exchange, Incorporated (the
``Exchange'' or ``C2'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Options Regulatory Fee. The text
of the proposed rule change is available on the Exchange's Web site
(http://www.c2exchange.com/Legal/), at the Exchange's Office of the
Secretary, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to decrease the Options Regulatory Fee
(``ORF'') from $.0051 to $.0015 per contract in order to help ensure
that revenue collected from the ORF, in combination with other
regulatory fees and fines, does not exceed the Exchange's total
regulatory costs. The proposed fee change would be operative on
February 1, 2016.
    The ORF is assessed by the Exchange to each Permit Holder for all
options transactions executed or cleared by the Permit Holder that are
cleared by The Options Clearing Corporation (``OCC'') in the customer
range (i.e., transactions that clear in a customer account at OCC)
regardless of the exchange on which the transaction occurs. In other
words, the Exchange imposes the ORF on all customer-range transactions
executed by a Permit Holder, even if the transactions do not take place
on the Exchange. The ORF also is charged for transactions that are not
executed by a Permit Holder but are ultimately cleared by a Permit
Holder. In the case where a Permit Holder executes a transaction and a
different Permit Holder clears the transaction, the ORF is assessed to
the Permit Holder who executed the transaction. In the case where a
non-Permit Holder executes a transaction and a Permit Holder clears the
transaction, the ORF is assessed to the Permit Holder who clears the
transaction. The ORF is collected indirectly from Permit Holders
through their clearing firms by OCC on behalf of the Exchange.
    The ORF is designed to recover a material portion of the costs to
the Exchange of the supervision and regulation of Permit Holder
customer options business, including performing routine surveillances,
investigations, examinations, financial monitoring, as well as policy,
rulemaking, interpretive and enforcement activities. The Exchange
believes that revenue generated from the ORF, when combined with all of
the Exchange's other regulatory fees and fines, will cover a material
portion, but not all, of the Exchange's regulatory costs. The Exchange
notes that its regulatory responsibilities with respect to Permit
Holder compliance with options sales practice rules have largely been
allocated to FINRA under a 17d-2 agreement.\3\ The ORF is not designed
to cover the cost of that options sales practice regulation.
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    \3\ See Securities Exchange Act Release No. 76309 (October 29,
2015), 80 FR 68361 (November 4, 2015).
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    The Exchange will continue to monitor the amount of revenue
collected from the ORF to ensure that it, in combination with its other
regulatory fees and fines, does not exceed the Exchange's total
regulatory costs. The Exchange monitors its regulatory costs and
revenues at a minimum on a semi-annual basis. If the Exchange
determines regulatory revenues exceed or are insufficient to cover a
material portion of its regulatory costs, the Exchange will adjust the
ORF by submitting a fee change filing to the Commission. The Exchange
notifies Permit Holders of adjustments to the ORF via regulatory
circular. The Exchange endeavors to provide Permit Holders with such
notice at least 30 calendar days prior to the effective date of the
change.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\4\ Specifically, the
Exchange believes the proposed rule change is consistent with Section
6(b)(4) of the Act,\5\ which provides that Exchange rules may provide
for the

equitable allocation of reasonable dues, fees, and other charges among
its Permit Holders and other persons using its facilities.
Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \6\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(4).
    \6\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes the proposed fee change is reasonable because
it would help the Exchange offset increased regulatory costs but would
not result in total regulatory revenue exceeding total regulatory
costs. Moreover, the Exchange believes the ORF ensures fairness by
assessing higher fees to those Permit Holders that require more
Exchange regulatory services based on the amount of customer options
business they conduct. Regulating customer trading activity is much
more labor intensive and requires greater expenditure of human and
technical resources than regulating non-customer trading activity,
which tends to be more automated and less labor-intensive. As a result,
the costs associated with administering the customer component of the
Exchange's overall regulatory program are materially higher than the
costs associated with administering the non-customer component (e.g.,
Permit Holder proprietary transactions) of its regulatory program.\7\
The Exchange believes the proposed fee change is equitable and not
unfairly discriminatory in that it is charged to all Permit Holders on
all their transactions that clear in the customer range at the OCC.
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    \7\ If the Exchange changes its method of funding regulation or
if circumstances otherwise change in the future, the Exchange may
decide to modify the ORF or assess a separate regulatory fee on
Permit Holder proprietary transactions if the Exchange deems it
advisable.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    C2 does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, because it applies to all
Permit Holders. The proposed ORF is comparable to fees charged by other
options exchanges for the same or similar service. The Exchange
believes any burden on competition imposed by the proposed rule change
is outweighed by the need to help the Exchange adequately fund its
regulatory activities to ensure compliance with the Exchange Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange neither solicited nor received comments on the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \8\ and paragraph (f) of Rule 19b-4 \9\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-C2-2016-001 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-C2-2016-001. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-C2-2016-001 and should be
submitted on or before February 24, 2016.
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    \10\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-01931 Filed 2-2-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: September 30, 2009 (Volume 74, Number 188)]
[Notices]
[Page 50201-50202]
[DOCID:fr30se09-50]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0509; FRL-8435-1]

Pseudomonas syringae; Registration Review Final Decision; Notice
of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's final
registration review decision for the pesticide Pseudomonas syringae,
case 6007. Registration review is EPA's periodic review of pesticide
registrations to ensure that each pesticide continues to satisfy the
statutory standard for registration, that is, that the pesticide can
perform its intended function without causing unreasonable adverse
effects on human health or the environment. Through this program, EPA
is ensuring that each pesticide's registration is based on current
scientific and other knowledge, including its effects on human health
and the environment.

FOR FURTHER INFORMATION CONTACT: For pesticide specific information,
contact: Susanne Cerrelli, Biopesticides and Pollution Prevention
Division (7511P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>    For general information on the registration review program,
contact: Kevin Costello, Special Review and Reregistration Division
(7508P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail address:
costello.kevin @epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2007-0509. Publicly
available

docket materials are available either in the electronic docket at
http://www.regulations.gov, or, if only available in hard copy, at the
Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

II. Background

A. What Action is the Agency Taking?

    In accordance with 40 CFR 155.58(c), this notice announces the
availability of EPA's final registration review decision for
Pseudomonas syringae, case 6007. The Registration Review Case for
Pseudomonas syringae was composed of the following Active Ingredients:
     Pseudomonas syringae strains ESC-10 and ESC-11 (PC Codes 006441
and 006451) are microbial pesticides that are used to control various
molds and rots on harvested apples, cherries, pears, lemons, oranges,
grapefruit, potatoes, and sweet potatoes.
     Pseudomonas syringae strain 742RS (PC Code 006411) is a microbial
pesticide that is used to prevent or reduce the growth of frost-forming
bacteria on leaves and blossoms of almonds, apples, peaches, pears,
tomatoes, cherries, potatoes and strawberries:
     EPA has deleted the Pseudomonas syringae strain 742RS from the
registration case pursuant to 40 CFR 155.42(b)(5) because all
registrations of all products containing that active ingredient are
cancelled. The registrant submitted a voluntary cancellation request
for all products containing strain 742RS on April 7, 2008. These
proposed voluntary cancellations were published (73 FR 53007, September
12, 2008 FRL-8380-7. No comments were received to support Pseudomonas
syringae strain 742RS products, and they were cancelled on March 12,
2009.
     The exemption from the requirement of a tolerance for residues of
Pseudomonas syringae strain 742RS in or on all raw agricultural
commodities when applied as a frost protection agent or biological
control agent to growing agricultural crops in accordance with good
agricultural practices that is listed in 40 CFR 180.1114 was reassessed
on June 3, 2002 and it was determined that it meets the FQPA 1996
safety standard. The Agency will take separate action to propose
revision of any affected exemptions from the requirement of a tolerance
for Pseudomonas syringae strain 742RS that are not supported for import
use only.
     In accordance with 40 CFR 155.57, a registration review decision
is the Agency's determination whether a pesticide meets, or does not
meet, the standard for registration in FIFRA. EPA has considered
Pseudomonas syringae in light of the FIFRA standard for registration.
The Pseudomonas syringae Final Decision document in the docket
describes the Agency's rationale for issuing a registration review
final decision for this pesticide.
     In addition to the final registration review decision document,
the registration review docket for Pseudomonas syringae also includes
other relevant documents related to the registration review of this
case. The proposed registration review decision was posted to the
docket and the public was invited to submit any comments or new
information. During the 60-day comment period, no public comments were
received.
     In accordance with 40 CFR 155.58(c), the registration review case
docket for Pseudomonas syringae will remain open until all actions
required in the final decision have been completed.
     Background on the registration review program is provided at:
http://www.epa.gov/oppsrrd1/registration_review. Links to earlier
documents related to the registration review of this pesticide are
provided at: http:www.epa.gov/oppsrrd1/registration_review/
pseudomonas_syringae/index.htm.

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

    Section 3(g) of FIFRA and 40 CFR part 155, subpart C, provide
authority for this action.

List of Subjects

    Environmental protection, Pesticides and pests, Registration
review.

    Dated: September 17, 2009.
Keith A. Matthews,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
[FR Doc. E9-23218 Filed 9-29-09; 8:45 a.m.]

BILLING CODE 6560-50-S


[Federal Register: July 11, 2008 (Volume 73, Number 134)]
[Notices]
[Page 39964]
[DOCID:fr11jy08-49]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-N-0364] (formerly Docket Nos. 2006N-0466 and FDA-
2007-0650)

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Exceptions or Alternatives to
Labeling Requirements for Products Held by the Strategic National
Stockpile

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Exceptions or Alternatives to
Labeling Requirements for Products Held by the Strategic National
Stockpile'' has been approved by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 28, 2007
(72 FR 73589), the agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0614.
The approval expires on June 30, 2011. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: July 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-15795 Filed 7-10-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Rules and Regulations]
[Pages 62716-62719]
[FR Doc No: 2018-26355]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 16

[EPA-HQ-OEI-2014-0849; FRL-9941-44-OEI]

Revision of the Agency's Privacy Act Regulations for EPA-63

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action on revisions to the Agency's Privacy Act regulations in
order to exempt a new system of records, EPA-63, the eDiscovery
Enterprise Tool Suite, from certain requirements of the Privacy Act
because records in EPA's eDiscovery Enterprise Tool Suite are
maintained for use in civil and criminal actions. A notice has been
published in the Federal Register on July 27, 2018 for the creation of
this new system of records that will contain information collected
using the Agency's suite of tools that search and preserve
electronically stored information (ESI) in support of the Agency's
eDiscovery (electronic discovery) and Freedom of Information Act
processes.

DATES: This rule is effective on March 6, 2019 without further notice,
unless EPA receives adverse comment by January 7, 2019. If EPA receives
adverse comment, we will publish a timely withdrawal in the Federal
Register informing the public that the direct final rule will not take
effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OEI-2014-0849, at https://www.regulations.gov/. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e. on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Brian K. Thompson, Acting Director,
eDiscovery Division, Office of Enterprise Information Programs, U.S.
Environmental Protection Agency, Mail Code 2822T, 1200 Pennsylvania
Avenue NW, Washington, DC 20460; email: [email protected];
telephone number:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Why is EPA using a direct final rule?

    The EPA is publishing this rule without a prior proposed rule
because we view this as a noncontroversial action and anticipate no
adverse comment. However, in the ``Proposed Rules'' section of the
Federal Register, we are publishing a separate document that will serve
as the proposed rule to exempt a new system of records, EPA-63, the
eDiscovery Enterprise Tool Suite, from certain requirements of the
Privacy Act if adverse comments are received on this direct final rule.
We will not institute a second comment period on this action. Any
parties interested in commenting must do so at this time. For further
information about commenting on this rule, see the ADDRESSES section of
this document.
    If EPA receives adverse comment, we will publish a timely
withdrawal in the Federal Register informing the public that this
direct final rule will not take effect. We would address all public
comments in any subsequent final rule based on the proposed rule.

II. General Information

    The EPA published a Privacy Act system of records notice for
information collected using the eDiscovery Enterprise Tool Suite.
Depending on the specific need, the Agency will use a combination of
several electronic tools that together assist with the preservation,
search, processing, review and production of electronically stored
information (ESI). The tool suite will be used to preserve, search,
collect, sort and review ESI including email messages, word processing
documents, media files, spreadsheets, presentations, scanned documents
and data sets in support of legal discovery. The Agency will also use
these tools to search for ESI that is responsive to requests for
information submitted under the Freedom of Information Act (FOIA), or
other formal information requests.
    The records in EPA's eDiscovery Enterprise Tool Suite are
maintained for use in civil and criminal actions. The Agency's system
of records, EPA-63, is maintained by the Office of Environmental
Information, Office of Enterprise Information Programs, eDiscovery
Division, on behalf of Agency offices that will require use of the
eDiscovery tool suite for both civil and criminal actions. When
information is maintained for the purpose of civil actions, the
relevant provision of the Privacy Act is 5 U.S.C. 552a(d)(5) which
states ``nothing in this [Act] shall allow an individual access to any
information compiled in reasonable anticipation of a civil action or
proceeding.'' 5 U.S.C. 552a(d)(5).
    The system is also maintained for support of criminal enforcement
activity by the EPA. In those cases, the system

is maintained on behalf of the Criminal Investigation Division, Office
of Criminal Enforcement, Forensics, and Training, Office of Enforcement
and Compliance Assurance--a component of EPA that performs as its
principal function, activities pertaining to the enforcement of
criminal laws. When information is maintained for the purpose of
criminal cases, the relevant provision of the Privacy Act is 5 U.S.C.
552a(j)(2), which states that the head of an agency may promulgate
regulations to exempt the system from certain provisions of the Act if
the system is ``maintained by an agency or component thereof which
performs as its principal function any activity pertaining to the
enforcement of criminal laws, including police efforts to prevent,
control, or reduce crime or to apprehend criminals, and the activities
of prosecutors, courts, correctional, probation, pardon, or parole
authorities, and which consists of: (A) Information compiled for the
purpose of identifying individual criminal offenders and alleged
offenders and consisting only of identifying data and notations of
arrests, the nature and disposition of criminal charges, sentencing,
confinement, release, and parole and probation status; (B) information
compiled for the purpose of a criminal investigation, including reports
of informants and investigators, and associated with an identifiable
individual; or (C) reports identifiable to an individual compiled at
any stage of the process of enforcement of the criminal laws from
arrest or indictment through release from supervision.'' 5 U.S.C.
552a(j)(2). Accordingly the EPA-63 is exempt from 5 U.S.C. 552a(c)(3),
(c)(4), (d), (e)(1), (e)(2), (e)(3), (e)(4)(G), (e)(4)(H), (e)(5),
(e)(8) and (f)(2)-(f)(5) and (g):
    (1) From subsection (c)(3) because making available to a record
subject the accounting of disclosures from records concerning him/her
could reveal investigative interest on the part of EPA and/or the
Department of Justice. This would permit record subjects to impede the
investigation, e.g., destroy evidence, intimidate potential witnesses,
or flee the area to avoid inquiries or apprehension by law enforcement
personnel. Further, making available to a record subject the accounting
of disclosures could reveal the identity of a confidential source.
    (2) From subsection (c)(4) because no access to these records is
available under subsection (d) of the Privacy Act.
    (3) From subsection (d) because the records contained in these
systems relate to official federal investigations. Individual access to
these records could compromise ongoing investigations, reveal
confidential informants and/or sensitive investigative techniques used
in particular investigations, or constitute unwarranted invasions of
the personal privacy of third parties who are involved in a certain
investigation. Amendment of the records in either of these systems
would interfere with ongoing law enforcement proceedings and impose an
unworkable administrative burden by requiring law enforcement
investigations to be continuously reinvestigated.
    (4) From subsections (e)(1) and (e)(5) because in the course of law
enforcement investigations information may occasionally be obtained or
introduced the accuracy of which is unclear or which is not strictly
relevant or necessary to a specific investigation. In the interests of
effective law enforcement, it is appropriate to retain all information
that may aid in establishing patterns of criminal activity. Moreover,
it would impede any investigative process, whether civil or criminal,
if it were necessary to assure the relevance, accuracy, timeliness and
completeness of all information obtained.
    (5) From subsection (e)(2) because to comply with the requirements
of this subsection during the course of an investigation could impede
the information gathering process, thus hampering the investigation.
    (6) From subsection (e)(3) because to comply with the requirements
of this subsection during the course of an investigation could impede
the information gathering process, thus hampering the investigation.
    (7) From subsections (e)(4)(G) and (H) because no access to these
records is available under subsection (d) of the Privacy Act.
    (8) From subsection (e)(8) because complying with this provision
could prematurely reveal an ongoing criminal investigation to the
subject of the investigation.
    (9) From subsection (f)(2), (f)(3), (f)(4) and (f)(5) because this
system is exempt from the access and amendment provisions of subsection
(d).
    (10) From subsection (g) because EPA is claiming that this system
of records is exempt from subsections (c)(3) and (4), (d), (e)(1), (2),
(3), (4)(G) and (H), (5), and (8), and (f)(2), (3), (4) and (5) of the
Act, the provisions of subsection (g) of the Act are inapplicable and
are exempted to the extent that this system of records is exempted from
those subsections of the Act.
    A final relevant provision of the Privacy Act is 5 U.S.C. 552a
(k)(2), which states that the head of an agency may promulgate
regulations to exempt the system from certain provisions of the Act if
the system ``contains investigatory material compiled for law
enforcement purposes other than material within the scope of subsection
(j)(2)'' of 5 U.S.C. 552a. Accordingly EPA-63 is exempt from 5 U.S.C.
552a(c)(3), (d), (e)(1), (e)(4)(G), (e)(4)(H) and (f)(2)-(f)(5):
    (1) From subsection (c)(3) because making available to a record
subject the accounting of disclosures from records concerning him/her
could reveal investigative interest on the part of EPA and/or the
Department of Justice. This would permit record subjects to impede the
investigation, e.g., destroy evidence, intimidate potential witnesses,
or flee the area to avoid inquiries or apprehension by law enforcement
personnel. Further, making available to a record subject the accounting
of disclosures could reveal the identity of a confidential source.
    (2) From subsection (d) because the records contained in these
systems relate to official Federal investigations. Individual access to
these records could compromise ongoing investigations, reveal
confidential informants and/or sensitive investigative techniques used
in particular investigations, or constitute unwarranted invasions of
the personal privacy of third parties who are involved in a certain
investigation. Amendment of the records in either of these systems
would interfere with ongoing law enforcement proceedings and impose an
impossible administrative burden by requiring law enforcement
investigations to be continuously reinvestigated.
    (3) From subsection (e)(1) because in the course of law enforcement
investigations information may occasionally be obtained or introduced
the accuracy of which is unclear or which is not strictly relevant or
necessary to a specific investigation. In the interests of effective
law enforcement, it is appropriate to retain all information that may
aid in establishing patterns of criminal activity. Moreover, it would
impede any investigative process, whether civil or criminal, if it were
necessary to assure the relevance, accuracy, timeliness and
completeness of all information obtained.
    (4) From subsections (e)(4) (G) and (H), because no access to these
records is available under subsection (d) of the Privacy Act.
    (5) From subsection (f)(2), (f)(3), (f)(4) and (f)(5) because this
system is exempt from the access and amendment provisions of subsection
(d).

III. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is not an Executive Order 13771 regulatory action
because this action is not significant under Executive Order 12866.

C. Paperwork Reduction Act

    This action does not impose an information collection burden under
the PRA. This action contains no provisions constituting a collection
of information under the PRA.

D. Regulatory Flexibility Act

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities.

E. Unfunded Mandates Reform Act

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments.

F. Executive Order 13132 (Federalism)

    This action does not have federalism implications. It will not 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.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this action.

H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it does not concern an environmental
health risk or safety risk.

I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action does not have disproportionately
high and adverse human health or environmental effects on minority
populations, low-income populations and/or indigenous peoples, as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994).

L. The Congressional Review Act

    This rule is exempt from the CRA because it is a rule of agency
organization, procedure or practice that does not substantially affect
the rights or obligations of non-agency parties.

List of Subjects in 40 CFR Part 16

    Environmental protection, Administrative practice and procedure,
Confidential business information, Privacy, Government employees.

    Dated: November 14, 2018.
Vaughn Noga,
Principal Deputy Assistant Administrator.

    For the reasons stated in the preamble, title 40, chapter I, part
16 of the Code of Federal Regulations is amended as follows:

PART 16--IMPLEMENTATION OF PRIVACY ACT OF 1974

0
1. The authority citation for part 16 continues to read as follows:

    Authority: 5 U.S.C. 301, 552a (as revised).

0
2. Amend Sec.  16.11 by:
0
a. Adding the system number and name, EPA-63 eDiscovery Enterprise Tool
Suite, at the end of the list in paragraph (a);
0
b. Adding paragraph (c)(4);
0
c. Revising the first two sentences of paragraph (d); and
0
d. Revising the introductory text of paragraph (e).
    The additions and revisions read as follows:

Sec.  16.11   General exemptions.

    (a) * * *
    EPA-63 eDiscovery Enterprise Tool Suite.
* * * * *
    (c) * * *
    (4) The Agency's system of records, EPA-63 system of records is
maintained by the Office of Environmental Information, Office of
Enterprise Information Programs, on behalf of the Criminal
Investigation Division, Office of Criminal Enforcement, Forensics, and
Training, a component of EPA which performs as its principal function
activities pertaining to the enforcement of criminal laws. Authority
for the Division's criminal law enforcement activities comes from
Powers of Environmental Protection Agency, 18 U.S.C. 3063;
Comprehensive Environmental Response, Compensation and Liability Act,
42 U.S.C. 9603; Resource Conservation and Recovery Act, 42 U.S.C. 6928;
Federal Water Pollution Control Act, 33 U.S.C. 1319, 1321; Toxic
Substances Control Act, 15 U.S.C. 2614, 2615; Clean Air Act, 42 U.S.C.
7413; Federal Insecticide, Fungicide and Rodenticide Act, 7 U.S.C.
136j, 136l; Safe Drinking Water Act, 42 U.S.C. 300h-2, 300i-1; Noise
Control Act of 1972, 42 U.S.C. 4912; Emergency Planning and Community
Right-To-Know Act of 1986, 42 U.S.C. 11045; and the Marine Protection,
Research, and Sanctuaries Act of 1972, 33 U.S.C. 1415.
    (d) Scope of Exemption. EPA systems of records 17, 40, 46 and 63
are exempted from the following provisions of the PA: 5 U.S.C.
552a(c)(3) and (4); (d); (e)(1), (2), (3), (4)(G), and (H), (5), and
(8); (f)(2) through (5); and (g). To the extent that the exemption for
EPA systems of records 17, 40, 46 and 63 claimed under 5 U.S.C.
552a(j)(2) of the Act is held to be invalid, then an exemption under 5
U.S.C. 552a(k)(2) is claimed for these systems of records from (c)(3),
(d), (e)(1), (e)(4)(G), (H), and (f)(2) through (5). * * *
    (e) Reasons for exemption. EPA systems of records 17, 40, 46 and 63
are exempted from the above provisions of the PA for the following
reasons:
* * * * *

0
3. Amend Sec.  16.12 by:
0
a. Adding the system number and name, EPA-63 eDiscovery Enterprise Tool
Suite, at the end of the list in paragraph (a)(1);

0
b. Revising the first sentence in paragraph (a)(4)(i); and
0
c. Revising the introductory text in paragraph (a)(5).
    The addition and revisions read as follows:

Sec.  16.12   Specific exemptions.

    (a) * * *
    (1) * * *
    EPA-63 eDiscovery Enterprise Tool Suite.
* * * * *
    (4) * * * (i) EPA systems of records 17, 30, 40, 41, 46 and 63 are
exempted from the following provisions of the PA, subject to the
limitations set forth in 5 U.S.C. 552a(k)(2): 5 U.S.C. 552a(c)(3); (d);
(e)(1), (4)(G) and (4)(H); and (f)(2) through (5). * * *
* * * * *
    (5) Reasons for exemption. EPA systems of records 17, 21, 30, 40,
41, 46 and 63 are exempted from the above provisions of the PA for the
following reasons:
* * * * *
[FR Doc. 2018-26355 Filed 12-4-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Notices]
[Pages 61430-61433]
[FR Doc No: 2015-25957]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3456]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Recommended Recordkeeping for Cosmetic Good
Manufacturing Practices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on our proposed collection of certain
information. Under the Paperwork Reduction Act of 1995 (the PRA),
Federal Agencies must publish a notice in the Federal Register
concerning each proposed collection of information, including
collections of information in current guidance documents, and allow 60
days for public comment. This notice invites comments on the
recommended recordkeeping associated with our draft guidance entitled,
``Draft Guidance for Industry: Cosmetic Good Manufacturing Practices.''
Our draft guidance remains unchanged by this notice. We are publishing
this notice in compliance with the PRA. This notice does not represent
any new regulatory initiative.

DATES: Submit either electronic or written comments on the collection
of information by December 14, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2015-N-3456 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Recommended Recordkeeping for
Cosmetic Good Manufacturing Practices.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the 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, including
collections of information in current guidance documents, before
submitting the collection to OMB for approval. To comply with this
requirement, we are publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of our functions,
including whether the information will have practical utility; (2) the
accuracy of our 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.

Recommended Recordkeeping for Cosmetic Good Manufacturing Practices OMB
Control Number 0910-NEW

    The draft guidance, entitled ``Draft Guidance for Industry:
Cosmetic Good Manufacturing Practices,'' (available at http://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm353046.htm#Raw) provides guidance to industry and other stakeholders
(e.g., consumer interest groups, academia, other regulatory groups) on
our current thinking concerning what constitutes Good Manufacturing
Practices (GMPs) for cosmetics. It is intended to assist industry and
other stakeholders in identifying the standards and issues that can
affect the quality of cosmetic products. In addition, as part of an
international harmonization effort with the International Cooperation
on Cosmetic Regulations (ICCR), we agreed to consider the current
International Organization for Standardization (ISO) standard for
cosmetic GMPs (ISO 22716:2007) when developing the draft guidance. We
have incorporated elements of ISO 22716, as appropriate, and that are
consistent with our regulations.
    Section 301 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 331) prohibits the introduction, or delivery for
introduction, into interstate commerce of cosmetics that are
adulterated or misbranded. Manufacturers of cosmetics can reduce the
risk of adulterating or misbranding cosmetics by following the GMP
recommendations in the draft guidance.
    The draft guidance recommends that manufacturers of cosmetics
prepare written procedures and maintain records pertaining to: (1)
Buildings and facilities; (2) equipment; (3) personnel; (4) raw
materials; (5) production; (6) laboratory controls; (7) internal
audits; and, (8) complaints, adverse events, and recalls.
    We expect that manufacturers of cosmetics that choose to follow the
recommendations of this Cosmetic GMP draft guidance would maintain
records of their written procedures as well as their test methods or
other appropriate verification procedures. It is also possible that
manufacturers would obtain and maintain records of Certificates of
Analysis, test results, or other appropriate verification procedures
from their suppliers.
    GMP is concerned with both manufacturing and quality control
procedures. Manufacturers of cosmetics will use their written
procedures and records as that part of quality assurance aimed at
ensuring that products are consistently manufactured to a quality
appropriate to their intended use. Records would be compiled and
retained at each manufacturing facility.
    Description of Respondents: The respondents are manufacturers of
cosmetic products.
    Our draft guidance remains unchanged by this notice. We are
publishing this notice in compliance with the PRA. This notice does not
represent any new regulatory initiative.
    We estimate the burden of this collection of information as
follows:

                     Table 1--Estimated One-Time Burden to Establish Written Procedures \1\
----------------------------------------------------------------------------------------------------------------
                                                  No. of records                  Average burden
    Section of draft guidance         No. of            per        Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Buildings and Facilities--                   607               1             607               1             607
 Development of written
 procedures regarding
 maintaining the buildings and
 facilities used for
 manufacturing in a clean and
 orderly manner.................
Equipment--Development of                    607               1             607              36          21,852
 written procedures regarding
 calibration and maintenance of
 equipment......................
Personnel--Development of                    607               1             607             3.6           2,185
 written procedures regarding
 personnel, including
 documentation of education,
 training, and/or experience of
 personnel, and preventing
 microbial contamination from
 sick or infected personnel, and
 for hygienic practices.........

Raw Materials--Development of                607               1             607              10           6,070
 written procedures for
 identifying, storing,
 examining, testing,
 inventorying, handling, and
 controlling raw materials to
 ensure they conform to
 appropriate standards and
 specifications.................
Production--Development of                   607               1             607              68          41,276
 written procedures regarding
 manufacturing operations.......
Laboratory Controls--Development             607               1             607              45          27,315
 of written procedures regarding
 laboratory controls............
Internal Audit--Development of               607               1             607            10.7           6,495
 written procedures regarding
 internal audits................
Complaints, Adverse Events, and              607               1             607              12           7,284
 Recalls \2\--Development of
 written procedures regarding
 product complaints and consumer
 adverse events.................
Complaints, Adverse Events, and              607               1             607               6           3,642
 Recalls \2\--Records regarding
 returned product...............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         116,726
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ To avoid double-counting, the burden hour analysis in table 1 does not include burden hours already
  accounted for in the information collection approved under OMB control number 0910-0249 for our recall
  regulations (21 CFR part 7).

                   Table 2--Estimated Annual Recordkeeping Burden for Records Maintenance \1\
----------------------------------------------------------------------------------------------------------------
                                                  No. of records                  Average burden
    Section of draft guidance         No. of            per        Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Buildings and Facilities--                 1,518               1           1,518               2           3,036
 Records regarding maintaining
 the buildings and facilities
 used for manufacturing in a
 clean and orderly manner.......
Equipment--Records regarding               1,518               1           1,518             3.3           5,009
 calibration and maintenance of
 equipment......................
Personnel--Records regarding               1,518               1           1,518            41.1          62,390
 personnel, including
 documentation of education,
 training and/or experience of
 personnel, and preventing
 microbial contamination from
 sick or infected personnel, and
 for hygienic practices.........
Raw Materials--Records regarding           1,518               1           1,518           231.5         351,417
 identifying, storing,
 examining, testing,
 inventorying, handling, and
 controlling raw materials to
 ensure they conform to
 appropriate standards and
 specifications.................
Production--Records regarding              1,518               1           1,518             7.7          11,689
 manufacturing operations.......
Laboratory Controls--Records               1,518               1           1,518             1.2           1,822
 regarding laboratory controls..
Internal Audit--Records of                 1,518               1           1,518           231.5         351,417
 internal audits................
Complaints, Adverse Events, and            1,518               1           1,518            60.3          91,535
 Recalls \2\--Records regarding
 product complaints and consumer
 adverse events.................
Complaints, Adverse Events, and            1,518               1           1,518             5.1           7,742
 Recalls \2\--Records regarding
 returned product...............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         886,057
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ To avoid double-counting, the burden hour analysis in table 1 does not include burden hours already
  accounted for in the information collection approved under OMB control number 0910-0249 for our recall
  regulations (21 CFR part 7).

    In table 1 we list the one-time burdens associated with
establishing written procedures. In table 2 we list the annual burdens
associated with recordkeeping. We base our estimates of the number of
recordkeepers reported in column 2 of tables 1 and 2 on data available
to us, our knowledge of and experience with the cosmetics industry, and
our communications with industry, as well as our estimate of the number
of recordkeepers subject to cosmetic labeling regulations, published in
the Federal Register of June 25, 2014 (79 FR 36069). We estimate there
are 1,518 cosmetic product establishments in the United States (79 FR
36069 at 36070). We estimate that 20 percent of these (304
establishments) are large businesses and 80 percent (1,214
establishments) are small businesses. We further estimate that large
businesses are likely to have established written procedures and that
about half of the small businesses (607 establishments) may not have
established written procedures. Thus, for purposes of this analysis, we
assume that these 607 establishments will undertake to establish
written procedures recommended by the draft guidance, when it is
finalized, as reported in table 1, column 2. We

further assume that the 1,518 cosmetic product establishments may not
maintain all of the records recommended by the draft guidance. Thus,
for purposes of this analysis, we assume that 1,518 establishments will
keep the records recommended by the draft guidance, when it is
finalized, as reported in table 2, column 2. We further assume that if
multiple products are produced in the same facility, the written
procedures and recordkeeping will be shared among the multiple
products.
    We base our estimates of the number of records per recordkeeper and
the average burden per recordkeeping reported in columns 3 and 5 of
tables 1 and 2 on our experience with good manufacturing practices used
to control the identity and composition of food and dietary supplements
and to limit contaminants and prevent adulteration, as well as our
estimate of the burden of similar recordkeeping activities described in
the dietary supplement final rule published in the Federal Register of
June 25, 2007 (72 FR 34752 at 34916) (the June 25, 2007, final rule),
that established, in part 111 (21 CFR part 111), the minimum good
manufacturing practices necessary for dietary supplements. For the
recordkeeping recommendations listed in table 2, the recordkeeping
occasions consist of frequent brief entries of dates, temperatures,
monitoring results, or documentation that specific actions were taken.
Information might be recorded a few times a day, week, or month.
Because the records burden involves frequent brief entries, we did not
attempt to estimate the actual number of recordkeeping occasions for
these activities. We entered one as the default for the number of
records per recordkeeper and we calculated the average burden per
recordkeeping in column 5 based on the reported burden of similar
provisions estimated in the June 25, 2007, final rule, averaged across
the 1,460 firms covered by that final rule.
    The estimates for the recordkeeping burdens presented here are
averages. We anticipate that the time spent to develop written
procedures and recordkeeping would vary based on the type of cosmetic
product manufactured. The estimated burdens for developing
recordkeeping includes record maintenance, periodically reviewing
records to determine if they may be discarded, and any associated
documentation for that activity.
    This draft guidance also refers to previously approved collections
of information found in our regulations. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the PRA (44 U.S.C. 3501-3521). The collections of
information in our recall regulations in 21 CFR part 7 have been
approved under OMB control number 0910-0249. The collection of
information in 21 CFR 70.25, which requires that color additives
subject to certification be labeled with the lot number assigned by the
Color Certification Branch, has been approved under OMB control number
0910-0016.

    Dated: October 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25957 Filed 10-9-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 159 (Thursday, August 18, 2022)]
[Rules and Regulations]
[Pages 50765-50766]
[FR Doc No: 2022-17761]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1141

[Docket No. FDA-2019-N-3065]
RIN 0910-AI39

Tobacco Products; Required Warnings for Cigarette Packages and
Advertisements; Delayed Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; delay of effective date.

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

SUMMARY: As required by an order issued by the U.S. District Court for
the Eastern District of Texas, this action delays the effective date of
the final rule (``Tobacco Products; Required Warnings for Cigarette
Packages and Advertisements''), which published on March 18, 2020. The
new effective date is October 6, 2023.

DATES: The effective date of the rule amending 21 CFR part 1141
published at 85 FR 15638, March 18, 2020, and delayed at 85 FR 32293,
May 29, 2020; 86 FR 3793, January 15, 2021; 86 FR 36509, July 12, 2021;
86 FR 50855, September 13, 2021; 86 FR 70052, December 9, 2021; 87 FR
11295, March 1, 2022; and 87 FR 32990, June 1, 2022, is further delayed
until October 6, 2023.

FOR FURTHER INFORMATION CONTACT: Courtney Smith, Office of Regulations,
Center for Tobacco Products, Food and Drug Administration, Document
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver
Spring, MD 20993-0002, 1-877-287-1371, email:
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of March 18, 2020,
the Food and Drug Administration (FDA or Agency) issued a final rule
establishing new cigarette health warnings for cigarette packages and
advertisements. The final rule implements a provision of the Family
Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub.
L. 111-31) that requires FDA to issue regulations requiring color
graphics depicting the negative health consequences of smoking to
accompany new textual warning label statements. The Tobacco Control Act
amends the Federal Cigarette Labeling and Advertising Act of 1965 (Pub.
L. 89-92) to require each cigarette package and advertisement to bear
one of the new required warnings. The final rule specifies the 11 new
textual warning label statements and accompanying color graphics.
Pursuant to section 201(b) of the Tobacco Control Act, the rule was
published with an effective date of June 18, 2021, 15 months after the
date of publication of the final rule.
    On April 3, 2020, the final rule was challenged in the U.S.
District Court for the Eastern District of Texas.\1\ On May 8, 2020,
the court granted a joint motion to govern proceedings in that case and
postpone the effective date of the final rule by 120 days.\2\ On
December 2, 2020, the court granted a new motion by the plaintiffs to
postpone the effective date of the final rule by an additional 90
days.\3\ On March 2, 2021, the court granted another motion by the
plaintiffs to postpone the effective date of the final rule by an
additional 90 days.\4\ On May 21, 2021, the court granted another
motion by the plaintiffs to postpone the effective date of the final
rule by an additional 90 days.\5\ On August 18, 2021, the court issued
an order to postpone the effective date of the final rule by an
additional 90 days.\6\ On November 12, 2021, the court issued another
order to postpone the effective date of the final rule by an additional
90 days.\7\ On February 10, 2022, the court issued another order to
postpone the effective date of the final rule by an additional 90
days.\8\ On May 10, 2022, the court issued another order to postpone
the effective date of the final rule by an additional 90 days.\9\ On
August 10, 2022, the court granted a motion by the plaintiffs to
postpone the effective date of the final rule by an additional 90
days.\10\ The court ordered that the new effective date of the final
rule is October 6, 2023. Pursuant to the court order, any obligation to
comply with a deadline tied to the effective date is similarly
postponed, and those obligations and deadlines are now tied to the
postponed effective date.
---------------------------------------------------------------------------

    \1\ R.J. Reynolds Tobacco Co. et al. v. United States Food and
Drug Administration et al., No. 6:20-cv-00176 (E.D. Tex. filed April
3, 2020).
    \2\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex. May
8, 2020) (order granting joint motion and establishing schedule),
Doc. No. 33.
    \3\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex.
December 2, 2020) (order granting Plaintiffs' motion and postponing
effective date), Doc. No. 80.
    \4\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex.
March 2, 2021) (order granting Plaintiffs' motion and postponing
effective date), Doc. No. 89.
    \5\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex. May
21, 2021) (order granting Plaintiffs' motion and postponing
effective date), Doc. No. 91.
    \6\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex.
August 18, 2021) (order postponing effective date), Doc. No. 92.
    \7\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex.
November 12, 2021) (order postponing effective date), Doc. No. 93.
    \8\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex.
February 10, 2022) (order postponing effective date), Doc. No. 94.
    \9\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex. May
10, 2022) (order postponing effective date), Doc. No. 96.
    \10\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex.
August 10, 2022) (order granting Plaintiffs' motion and postponing
effective date), Doc. No. 100.
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    To the extent that 5 U.S.C. 553 applies to this action, the
Agency's implementation of this action without opportunity for public
comment, effective immediately upon publication today in the Federal
Register, is based on the good cause exception in 5 U.S.C. 553(b)(B).
Seeking public comment is impracticable, unnecessary, and contrary to
the public interest. The 90-day postponement of the effective date,
until October 6, 2023, is required by court order in accordance with
the court's authority to postpone a rule's effective date pending
judicial review (5 U.S.C. 705). Seeking prior public comment on this
postponement would have been impracticable, as well as contrary to the
public interest in the orderly issuance and implementation of
regulations.

    Dated: August 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17761 Filed 8-17-22; 8:45 am]
BILLING CODE 4164-01-P