[Federal Register Volume 87, Number 234 (Wednesday, December 7, 2022)]
[Notices]
[Pages 75052-75054]
[FR Doc No: 2022-26564]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2301]

Small Volume Parenteral Drug Products and Pharmacy Bulk Packages
for Parenteral Nutrition: Aluminum Content and Labeling
Recommendations; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Small
Volume Parenteral Drug Products and Pharmacy Bulk Packages for
Parenteral Nutrition: Aluminum Content and Labeling Recommendations.''
This draft guidance is intended to clarify the key factors in
determining the appropriate aluminum content in a small volume
parenteral (SVP) drug product and/or a pharmacy bulk package (PBP)
intended as a component of parenteral nutrition (PN) and provide FDA's
recommendations regarding the concentration of aluminum in SVP drug
products and PBPs for PN. Additionally, this guidance is intended to
assist applicants in determining the appropriate content and placement
of information on aluminum in SVP and PBP human prescription drug
product labeling.

DATES: Submit either electronic or written comments on the draft
guidance by February 6, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-2301 for ``Small Volume Parenteral Drug Products and
Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and
Labeling Recommendations.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The

second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Thao Vu, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5232, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Small Volume Parenteral Drug Products and Pharmacy Bulk
Packages for Parenteral Nutrition: Aluminum Content and Labeling
Recommendations.'' Aluminum, one of the most abundant metallic elements
on earth, occurs naturally in several minerals, ores, oxides, and
silicates. Although humans are exposed to aluminum through drinking
water, foods, and drugs, aluminum's oral bioavailability is poor, so
healthy individuals typically face little risk of toxicity. Despite
that, aluminum toxicity has been documented in medical literature for
more than 30 years, with manifestations that include osteomalacia and
reduced bone mineralization, neurological dysfunction and dialysis
encephalopathy, microcytic hypochromic anemia, and cholestasis.
    A long-implicated, major source of aluminum exposure is PN,
resulting from contamination of ingredients. Patients with underlying
renal impairment who receive prolonged courses of PN support are at
greatest risk of exposure to toxic levels of aluminum from PN. Preterm
neonates and infants who often require many days of PN support and have
immature kidneys that are incapable of excreting aluminum efficiently
are at particularly high risk.
    Research indicates that patients with renal impairment, including
premature neonates, who receive parenteral levels of aluminum at
greater than 4 to 5 microgram/kilogram/day (mcg/kg/day) accumulate
aluminum at levels associated with central nervous system and bone
toxicity. Because patients with renal impairment, including all preterm
neonates, comprise a major portion of those requiring PN support, we
recommend that the total aluminum exposure (TAE) from PN uniformly
should not exceed 5 mcg/kg/day. To determine TAE, one must consider all
sources of aluminum content in PN, including each large volume
parenteral and each SVP drug product and PBP in PN. This guidance
describes an approach to deriving the recommended aluminum
concentration limit in an SVP drug product for PN, based on the
proposed clinical dose, concentration of drug or dose volume, and the
known or estimated contribution of aluminum from other products in the
PN.
    Additionally, this guidance is intended to assist applicants in
determining the appropriate content and placement of information on
aluminum in SVP and PBP human prescription drug product labeling. This
guidance provides recommendations to help ensure that information on
the aluminum content is appropriate and placed in the proper sections
and subsections within the Highlights of Prescribing Information and on
the container label and carton labeling. This will help to assure that
the information is clear and accessible to healthcare practitioners and
includes content that guides the safe and effective use of the drug
product.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Small Volume
Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral
Nutrition: Aluminum Content and Labeling Recommendations.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 314 have been approved under OMB control
number 0910-0001. The collections of information in 21 CFR part 312
have been approved under OMB control number 0910-0014. The collections
of information in FDA's guidance entitled ``Formal Meetings Between the
FDA and Sponsors or Applicants of PDUFA Products'' (available at
https://www.fda.gov/media/109951/download) have been approved under OMB
control numbers 0910-0001 and 0910-0429. The collections of information
in 21 CFR 201.56 and 201.57 have been approved under OMB control number
0910-0572. The collections of information in FDA's guidance entitled
``Formal Meetings Between FDA and ANDA Applicants of Complex Products
Under GDUFA'' (available at https://www.fda.gov/media/107626/download)
have been approved under OMB control number 0910-0718. The collections
of information in FDA's guidance entitled ``Controlled Correspondence
Related to Generic Drug Development'' (available at https://www.fda.gov/media/109232/download) have been approved under OMB control
number 0910-0797.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: December 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26564 Filed 12-6-22; 8:45 am]
BILLING CODE 4164-01-P


0

                                                                              8

                                                                          536.4

4) Gather Information

                                                                              0

                                                                             22

                                                                              0

                                                                             22

                                                                         1475.1

5) Compile and Review

                                                                              1

                                                                             20

                                                                              0

                                                                             21

                                                                        1444.62

6) Complete Paperwork

                                                                              1

                                                                              0

                                                                              2

                                                                              3

                                                                         171.32

7) Submit and File

                                                                              0

                                                                              0

                                                                              1

                                                                              1

                                                                          33.85

Total

                                                                              3

                                                                             53

                                                                              3

                                                                             59

                                                                      $3,966.06 Type 4 PCT DCI -	Burden: 59 hours per response x 1 response x 1 DCI= 59 hours  			Cost: $3,966 per response x 1 response x 1 DCI = $3,966

      6(b)	Estimating Respondent Costs - AR/PCT DCIs              The total annual cost for all respondents of AR and PCT DCIs is estimated to be $1,925,436.  Respondent costs are based on managerial, technical and clerical burden hours estimated at $103.62, $67.05, and $33.85 per hour, respectively.                6(c)	Estimating Agency Burden and Costs  -  AR/PCT

      The Agency's annual burden hours and costs for developing DCI correspondence, communication with registrants, developing documents, tracking and storing the evaluation of the data submissions, and other DCI processing activities is detailed in Table 5 and Table 6 below.  For this renewal, EPA projects the same number of burden hours associated with the performance of the duties issuing and processing AR DCIs as was projected in the last ICR.  Thus, like the last ICR, this renewal will project the Agency will process 4 AR DCIs and 1 PCT DCI annually.

                                   TABLE 5   Annual Estimated Agency Burden Hour and Cost For Processing AR DCIs Types 1-3

Burden Hours (per year)

Total

Collection Activities

Mgmt. $101.16

Tech.  $66.88

Cler.  $39.23

Hours

Costs

Develop DCI notice

                                                                              1

                                                                              0

                                                                              2

                                                                              3

                                                                         179.62

Answer Registrants' questions

                                                                              0

                                                                              4

                                                                              5

                                                                              9

                                                                         463.67

IN-process data submissions

                                                                              0

                                                                              0

                                                                              4

                                                                              4

                                                                         156.92

Analyze data

                                                                              1

                                                                             80

                                                                              0

                                                                             81

                                                                        5451.56

Record and store DCI data

                                                                              0

                                                                              0

                                                                              2

                                                                              2

                                                                          78.46

Total

                                                                              2

                                                                             84

                                                                             13

                                                                             99

                                                                      $6,330.23 AR DCIs Types 1-3  	 Annual Estimated Agency Burden: 99 hours x 16 responses = 1,584 hrs Annual Estimated Agency Cost: $6,330 x 16 responses = $101,280.                                                                             TABLE 6  Annual Estimated Agency Burden Hours and Costs for  Processing Type 4 - PCT DCIs

Burden Hours (per year)

Total

Collection Activities

Mgmt. $101.16

Tech.  $66.88

Cler.  $39.23

Hours

Costs

Develop DCI notice

                                                                              1

                                                                              0

                                                                              2

                                                                              3

                                                                         140.39

Answer Registrants' questions

                                                                              0

                                                                              4

                                                                              5

                                                                              9

                                                                         463.67

IN-process data submissions

                                                                              0

                                                                              0

                                                                              4

                                                                              4

                                                                         156.92

Analyze data

                                                                              1

                                                                             40

                                                                              0

                                                                             41

                                                                        2776.36

Record and store DCI data

                                                                              0

                                                                              0

                                                                              2

                                                                              2

                                                                          78.46

Total

                                                                              2

                                                                             44

                                                                             13

                                                                             59

                                                                       $3615.80 Type 4 PCT DCIs  - Estimated Annual Agency Burden Activities   Hours: 59 hours x 1 response = 59 hours Costs: $3,616 x 1 response = $3,616

      6(d)	Bottom Line Burden Hours and Cost Table

      The total estimated annual respondent burden is 28,569 burden hours (28,509 burden hours for all AR DCI submissions + 59 burden hours for PCT DCI submissions), with an associated cost of $1,925,436 ($1,921,471 or all AR DCI submissions + $3,965 for PCT DCI submissions) see table below.

      The total estimated annual Agency burden is 1,643 burden hours (1,584 burden hours for all AR DCI submissions + 59 burden hours for PCT DCI submissions), with an associated cost of $104,896 ($101,280 for all AR DCI submissions + $3,616 for PCT DCI submissions). See Table 7 below.            Table 7. Annual Bottom Line Hours and Costs/Master Table

Key Activities

                                                                          Hours

                                                                          Costs

Respondents

Type 1- DCI: generating anticipated residue data.

                                                                         27,272

                                                                     $1,828,886

Type 2- DCI for submitting minimal verification of use information

                                                                            690

                                                                        $52,940

Type 3- submitting anticipated residue data from publicly available sources

                                                                            548

                                                                        $39,644

Type 4- submitting percent crop treated data using existing information.

                                                                             59

                                                                         $3,966

Total estimated respondent burden/costs.

                                                                         28,569

                                                                     $1,926,436

Agency

Type 1-3 AR DCIs for managing anticipated residue DCI's

                                                                          1,584                                                                         101,280

Type -4 PCT DCIs for managing percent crop treated DCI's.

                                                                             59

                                                                         $3,616

Total Agency burden/costs.

                                                                          1,643

                                                                       $104,896              6(e)	Reasons for Change in Burden - AR/PCT              For this ICR renewal the annual estimated respondent burden hours are 28,569 hours at a cost of $1,925,436.  There is no increase in the burden hours over the last ICR renewal.  However, the costs have decreased slightly due to the adjustment attributable to EPA's re-estimation of labor rates for industry and the Agency.  This is a program adjustment.               6(f)	Burden Statement - AR/PCT              The estimated total respondent burden for this ICR over the next three years is 85,707 hours with the annual burden hours ranging from 59 hours to 13,636 hours per response, depending on the type of DCI.                               Part 4 -  Section 6: Estimating the Burden and Cost of the Collection for the Enforcement and Unanticipated Incidents

Part 4 describes the burden activities associated with the Enforcement and Unanticipated Incident DCI activities.

      6(a)   Estimating Respondent Burden  -  Enforcement and Unanticipated Incident               The total estimated annual respondent burden hours and costs for Enforcement and Unanticipated Incident DCI is estimated at 6,266 burden hours for the life of the ICR.                  The potential number of DCIs required, the type of data, and the number of respondents potentially affected is quite variable.  Thus, a this type of DCI may request data on more than one pesticide, and may involve two or more respondents who are encouraged to join together to provide the needed data.  The variability inherent in this type of  DCI means the estimates serve only as a proxy for what the actual burdens are likely to be. The annual burden estimate is based on the following assumptions: (a) that the Agency would issue only one DCI for this type of activity and only once during the life cycle of the ICR and (b) for the DCI issued there would be one response.  The Agency has also assumed an average total test cost of $500,000 per Enforcement and Unanticipated Incident DCI.                 Historically, there is very little information documenting the need for this type of DCI but such events have occurred.  For example one of the worst cases occurred in 1976 when the  Food an Drug Administration (FDA) conducting a routine inspection uncovered deficiencies in the manner in which studies were being conducted at Industrial Biotest Laboratories, Inc., (IBT) one of the largest independent laboratories in the U.S. at the time.  By 1978 EPA and FDA were conducting joint audits of two other IBT facilities and uncovered similar problems and the case had been referred to the Department of Justice. This turned out to be a massive undertaking.  Of  the 1205 IBT studies identified by EPA, 801 studies, or  approximately 66%, were considered significant to regulatory decisions such as the induction of tumors, birth defects, genetic mutations, neurotoxicity and other chronic reproductive effects.  Of the 801 studies considered significant to regulatory decisions, 594  were found to be invalid by EPA and Canada.  By 1983, EPA warned pesticide product registrants that products supported by invalid health effects studies conducted by IBT faced suspension action unless replaced by other tests or a commitment to further testing. (EPA Releases Report on IBT Lab Studies; Warns of Suspension Action, Environmental News EPA Press Release, Monday July 11, 1983) (see also House of Representatives, Committee on Agriculture, Washington, DC, Improving Data- Pesticide Decisions, July 27 1983; Statement of Edwin Johnson, Director, Office of Pesticide Programs, Environmental Protection Agency)                      The estimate of respondent burden hours per response for Enforcement and Unanticipated Incident Activities is 6,266 hours and is based on the same burden hour break down projected in the 2001 ICR OMB 2070-0122; EPA No. 1503.04 which the Agency allowed to expire 12/31/04.  The estimated Agency burden hours is based on Agency estimates similar to the burdens projected for the special review program, 1348 burden hours.  While the Agency does not anticipate using any of these burden hours, the Agency will project a one time burden estimate for the three year life cycle of ICR. Table 1 lists the potential respondent burden hours and costs and Table 2 lists the potential Agency burden hours and costs and Table 3, lists the potential  three year bottom line totals for Enforcement and Unanticipated Incident Activities.                 6(b).	Estimating Respondent Costs - Enforcement Unanticipated Incident Activities               The estimated three year cost for all respondents for Enforcement Unanticipated Incident Activities is estimated to be $420,291.   Respondent costs are based on managerial, technical and clerical burden hours estimated at $103.62, $67.05, and $33.85 per hour, respectively.

TABLE 1.   TOTAL RESPONDENT BURDEN/COST ESTIMATES Enforcement and Unanticipated Incident DCI

	Burden Hours (per year)

                                    Totals

Collection Activities

                                 Mgmt. $103.62

                                 Tech. $67.05

                                     Cler.                                      $33.85

                                     Hours

                                     Costs

1)Read Instructions

                                                                              2

                                                                              0

                                                                              0

                                                                              2

                                                                         207.24

2)Plan Activities

                                                                              2

                                                                              0

                                                                              0

                                                                              2

                                                                         207.24

3)Create  Information

                                                                              0

                                                                          6,249

                                                                              0

                                                                          6,249

                                                                    418,6995.45

4)Gather Information

                                                                              0

                                                                              3

                                                                              0

                                                                              3

                                                                         201.15

5)Compile and Review

                                                                              1

                                                                              4

                                                                              0

                                                                              5

                                                                         371.82

6)Complete Paperwork

                                                                              2

                                                                              0

                                                                              2

                                                                              4

                                                                         274.94

7)Submit and File

                                                                              0

                                                                              0

                                                                              1

                                                                              1

                                                                          33.85

Total

                                                                              7

                                                                          6,256

                                                                              3

                                                                          6,266

                                                                     420,291.69

TOTAL BURDEN HOURS: 6,266 hours x 1 response = 6,266 hours  TOTAL BURDEN COSTS: $420,291 x 1 response = $420,291

                    6(c).  	Estimating Agency Burden and Cost - Enforcement Unanticipated Incident Activities

TABLE 2:  TOTAL AGENCY BURDEN AND HOURS COST  Enforcement And Unanticipated Incident  DCI

	Collection                                    Activities

	Burden Hours

                                     Total

	Mgmt. 	$101.16/hr

	Tech. 	$66.88/hr

	Cler. 	$39.23/hr

                                     Hours

                                     Cost

Develop DCI correspondence needed

                                      32

	160

	60

                                      252                                                                                16,291.72

Answer registrants' questions regarding the DCI

	4

	160

	0

                                      164                                                                                11,105.44

Review and analyze data submissions

	4

	880

	0

                                      884                                                                                59,259.04

Record DCI submissions

	0

	0

	40

                                      40                                                                                1569.20

Store Data

	0

	0

      8

                                       8                                                                                313.84

TOTAL

	40

                                     1,200

	108

                                     1,348                                                                                88,539.24       Hours: 1348 per response X 1 responses X 1 DCI =   1348 Hours        Costs: $88,539 per response X 1 responses X 1 DCI = $88,539         6(d). 	Bottom Line Burden Hours and Cost Tables/ Master Table for Enforcement and Unanticipated Incident DCI                 Table 3: Bottom Line Burden Hours and Costs/ Master Table

                    Enforcement and Unanticipated Incidents

                              Number of Responses

                                     Hours

                                     Cost

Respondents

                                     6,266

                                                                       $420,291

                                       1

Agency

                                     1348

                                                                        $88,539

                                       1

6(e). 	Reasons for Change in Burden - Enforcement and Unanticipated Incident DCIs               This new ICR burden will result in a increase in the total estimated respondent burden of 6,266 hours for the three year life cycle of this ICR (or 2,088 burden hours annually).  This is a new program activity.

6(f).  Burden Statement - Enforcement and Unanticipated Incident DCIs

      The total respondent burden for the information collection activities for the three year life cycle of this ICR is estimated to average 6,266 burden hours for Enforcement and Unanticipated Incident activities.  The annualized burden for a single DCI is 2,088 hours.              According to the Paperwork Reduction Act, "burden" means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency.  For this collection, it is the time reading the regulations, planning the necessary data collection activities, conducting tests, analyzing data, generating reports and completing other required paperwork, and storing, filing, and maintaining the data.  The 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.  The OMB control number for this information collection appears at the beginning and the end of this document.  In addition OMB control numbers for EPA's regulations, after initial display in the final rule, are listed in 40 CFR part 9.

      The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OPP-2007-0923, which is available for online viewing at www.regulations.gov, or in person viewing at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA.  This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.  The docket telephone number is<PHONE_NUMBER>.  You may submit comments regarding the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden, including the use of automated collection techniques.                Comments may be submitted to EPA electronically through http://www.regulations.gov or by mail addressed to Director, Collection Strategies Division, U.S. Environmental Protection Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460.  You can also send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA.  Include docket ID No. EPA-HQ-OPP-2007-0923 and OMB control numbers 2070-0057; 2070-0107; and 2070-0164 in any correspondence but do not submit any DCI or other related information (e.g., forms, reports, etc.) to these addresses.

                    ATTACHMENTS TO THE SUPPORTING STATEMENT                                         Attachments to the supporting statement are available in the public docket established for this ICR under docket identification number EPA-HQ-OPP-2007-0923.  These attachments are available for online viewing at www.regulations.gov or otherwise accessed as described in this section 6(f) of the supporting statement.

Attachment A: 7 U.S.C. 136a-1 - Section 4 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Also available at online at the US House of Representatives' US Code website

Attachment B: 7 U.S.C. 136a  -  Section 3 of FIFRA. Also available at online at the US House of Representatives' US Code website

Attachment C: 71 FR 45719  -  Pesticides; Procedural for Regulations for Registration Review; Final Rule. Also available online at http://edocket.access.gpo.gov/2006/pdf/E6-12904.pdf

Attachment D: 21 U.S.C. 346a  -  Section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA). Also available at online at the US House of Representatives' US Code website

Attachment E: Public comment received from William M. Mahlburg, Director, Government Affairs, Nufarm, Americas, Inc.

E-1: Consultation questions and comment received from Rebeckah Freeman Adcock, Director, Congressional Relations, American Farm Bureau

E-2: Consultation questions for Ray McAlister, Vice President Science and Regulatory Affairs, CropLife America

E-3: Consultation questions for Susan Little, Executive Director, Consumer Specialty Products Association

E-4: Consultation questions for Daniel Botts, Director, FFDA's Environmental & Pest Management Division, Minor Crop Farmer Alliance Technical Committee (Chairman), Florida Fruit & Vegetable Association

Attachment F: Forms that are commonly associated with Data Call-ins  -  available electronically as a PDF file on the internet at http://www.epa.gov/opprd001/forms/ except as otherwise noted.

EPA Form No. 8570-4 - Confidential Statement of Formula

EPA Form No. 8570-27 - Formulator's Exemption Statement

EPA Form No. 8570-28 - Certification of Compliance with Data Gap Procedures

EPA Form No. 8570-32 - Certification of Attempt to Enter into an Agreement with Registrants for Development of Data Form

EPA Form No. 8570-34 - Certification with Respect to Citation of Data Form

EPA Form No. 8570-35 - Data Matrix Form

EPA Form No. 8570-36 - Summary of the Physical/Chemical Properties Form

EPA Form No. 8570-37 - Self-Certification Statement for the Physical/Chemical Properties

EPA Form No. 6300-3 - Requirements Status and Registrant's Response. This form is computer generated and uniquely pre-populated and sent directly to individual registrants.  Blank copies of this form may otherwise only be accessed via the docket for this ICR as described above using the docket identifier EPA-HQ-OPP-2007-0923-0003.

EPA Form No. 6300-4 - Data Call-In Response Form. This form is computer generated and uniquely pre-populated and sent directly to individual registrants.  Blank copies of this form may otherwise only be accessed via the docket for this ICR as described above using the docket identifier EPA-HQ-OPP-2007-0923-0003.

Attachment G: General Methodology Used to Estimate Paperwork Burden Hours and Costs by the Office of Pesticide Programs for Submission of Required Data/Information for Responding to a Data Call-In Notice.

Attachment H: Work Sheets to Calculate Industry and EPA Labor Costs


[Federal Register Volume 87, Number 170 (Friday, September 2, 2022)]
[Notices]
[Page 54231]
[FR Doc No: 2022-19037]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4663-DR; Docket ID FEMA-2022-0001]

Kentucky; Amendment No. 5 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Kentucky (FEMA-4663-DR), dated July 29, 2022,
and related determinations.

DATES: This amendment was issued August 5, 2022.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the Commonwealth of Kentucky is hereby amended to include debris
removal and permanent work for the following areas among those areas
determined to have been adversely affected by the event declared a
major disaster by the President in his declaration of July 29, 2022.

    Clay, Martin, and Perry Counties for debris removal [Category A]
and permanent work [Categories C-G] (already designated for
Individual Assistance and emergency protective measures [Category
B], including direct federal assistance, under the Public Assistance
program).

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-19037 Filed 9-1-22; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 88, Number 192 (Thursday, October 5, 2023)]
[Rules and Regulations]
[Pages 69036-69038]
[FR Doc No: 2023-22166]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0685]
RIN 1625-AA00

Safety Zone; Potomac River, Washington, DC

AGENCY: Coast Guard, Department of Homeland Security.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
certain waters of the Potomac River. The safety zone is needed to
protect personnel, vessels, and the marine environment on these
navigable waters near Washington, DC from potential hazards posed by a
fireworks display which will take place on October 5, 2023. Entry of
vessels or persons into this zone is prohibited unless specifically
authorized by the Captain of the Port, Maryland-National Capital
Region, or a designated representative.

DATES: This rule is effective from 7:30 p.m. until 9:30 p.m. on October
5, 2023.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2023-0685 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions about this rule,
call or email MST2 Hollie Givens, Sector Maryland-NCR, Waterways
Management Division, U.S. Coast Guard: telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section

U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the event sponsors did not notify the
Coast Guard of the event in time to allow for a notice and comment
period without delaying promulgation of the rule. It would be
impracticable and contrary to the public interest to delay the
establishment on this safety zone to publish an NPRM because doing so
would prevent us from addressing the potential safety hazards
associated with the fireworks display. Potential safety hazards include
the accidental discharge of fireworks, dangerous projectiles and
falling hot embers or other debris.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable and contrary to the public interest
because immediate action is needed to respond to the potential safety
hazards associated with the fireworks display.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port, Sector Maryland-National Capital Region
(COTP) has determined that potential hazards associated with the
fireworks to be used in this October 5, 2023, display will be a safety
concern for anyone near the fireworks discharge sites. This rule is
needed to protect personnel, vessels, and the marine environment in the
navigable waters within the safety zone before, during, and after the
scheduled event.

IV. Discussion of the Rule

    The COTP is establishing a safety zone from 7:30 p.m. to 9:30 p.m.
on October 5, 2023. The safety zone would cover all navigable waters of
the Potomac River within 500 feet of a fireworks barge in approximate
position latitude 38[deg]53'43.13'' N, latitude 77[deg]03'30.62'' W,
located near the John F. Kennedy Center for Performing Arts in
Washington, DC. The size of the zone and the duration of the rule are
intended to protect personnel, vessels, and the marine environment in
these navigable waters before, during, and after the scheduled
fireworks display. No vessel or person will be permitted to enter the
safety zone without obtaining permission from the COTP or designated
representative.

V. Regulatory Analyses

    We developed this 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

    Executive Orders 12866 and 13563 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. This rule has not been designated a ``significant
regulatory action,'' under section 3(f) of Executive Order 12866, as
amended by Executive Order 14094 (Modernizing Regulatory Review).
Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB).
    This regulatory action determination is based on the size,
duration, and time-of-day of the safety zone, which will impact a
small, designated area of the Potomac River for no more than two hours
of total enforcement--hours during the evening, when vessel traffic is
normally low. Moreover, the Coast Guard will issue a Local Notice to
Mariners and a Broadcast Notice to Mariners via VHF-FM marine channel
16, to inform them about the safety zone.

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 rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    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 rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This 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 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 rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and

responsibilities between the Federal Government and Indian tribes.

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 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 rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined 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 rule involves a
safety zone lasting only 2 hours that will prohibit entry within 500
feet of a barge within a portion of the Potomac River. It is
categorically excluded from further review under paragraph L63(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
Record of Environmental Consideration supporting this determination is
available in the docket. For instructions on locating the docket, see
the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email 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.

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T05-0685 to read as follows:

Sec.  165.T05-0685  Safety Zone; Potomac River, Washington, DC.

    (a) Location. The following area is a safety zone: All navigable
waters of the Potomac River within 500 feet of the fireworks barge in
approximate position latitude 38[deg]53'43.13'' N, longitude
77[deg]03'30.62'' W located near the John F. Kennedy Center for
Performing Arts, Washington, DC. These coordinates are based on datum
NAD 83.
    (b) Definitions. As used in this section--
    Captain of the Port (COTP) means the Commander, U.S. Coast Guard
Sector Maryland-National Capital Region.
    Designated representative means any Coast Guard commissioned,
warrant, or petty officer who has been authorized by the Captain of the
Port National Capital Region to assist in the enforcing of the safety
zone as described in paragraph (a) of this section.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by telephone at<PHONE_NUMBER> or on Marine Band Radio
VHF-FM channel 16 (156.8 MHz). The Coast Guard vessels enforcing this
section can be contacted on Marine Band Radio VHF-FM channel 16 (156.8
MHz). Those in the safety zone must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative.
    (d) Enforcement period. This section will be enforced from 7:30
p.m. to 9:30 p.m. on October 5, 2023.

    Dated: September 29, 2023.
David O'Connell,
Captain, U.S. Coast Guard, Captain of the Port Maryland-National
Capital Region.
[FR Doc. 2023-22166 Filed 10-4-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Proposed Rules]
[Pages 66845-66847]
[FR Doc No: 2015-27703]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. FDA-2015-D-3719]

Draft Guidances Relating to the Regulation of Human Cells,
Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a 1-day public hearing to obtain input on four recently issued draft
guidances relating to the regulation of human cells, tissues, or
cellular or tissue-based products (HCT/Ps). These draft guidances were
issued by FDA in response to stakeholders' requests for guidance on
FDA's current views about how manufacturers, establishments, and
distributors of HCT/Ps and health care professionals can meet the
criteria under the Agency's regulations that apply to HCT/Ps. FDA will
consider information it obtains from the public hearing in the
finalization of these guidances.

DATES: The public hearing will be held on April 13, 2016, from 8 a.m.
to 5 p.m. The meeting may be extended or end early depending on the
level of public participation. Persons seeking to attend or to present
at the public hearing must register by January 8, 2016. Section IV
provides attendance and registration information. Electronic or written
comments will be accepted after the public hearing until April 29,
2016.

ADDRESSES: The public hearing will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public hearing
participants (non-FDA employees) is through Building 1, where routine
security check procedures will be performed. For parking and security
information, please refer to http://www.fda.gov/aboutfda/workingatfda/buildingsandfacilities/whiteoakcampusinformation/ucm241740.htm.
    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-D-3719 for ``Draft Guidances Relating to the Regulation of
Human Cells, Tissues, or Cellular or Tissue-Based Products; Public
Hearing; Request for Comments.'' 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.
    A link to the live Webcast of this public hearing will be available
at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm on the day of the public
hearing. A video record of the public hearing will be available at
http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm. A video record of the
public hearing will be available at the same Web site address for 1
year.

FOR FURTHER INFORMATION CONTACT: Lori Jo Churchyard, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-
402-7911<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    HCT/Ps are defined in Sec.  1271.3(d) (21 CFR 1271.3(d)) as
articles containing or consisting of human cells or tissues that are
intended for implantation, transplantation, infusion, or transfer into
a human recipient. FDA has implemented a risk-based approach to the
regulation of HCT/Ps. Under the authority of section 361 of the Public
Health Service (PHS) Act (42 U.S.C. 264), FDA established regulations
for all HCT/Ps to prevent the introduction, transmission, and spread of
communicable diseases. These regulations can be found in part 1271. An
HCT/P is regulated solely under section 361 of the PHS Act and part
1271, if it meets all of the following criteria (Sec.  1271.10(a)):
     The HCT/P is minimally manipulated;
     The HCT/P is intended for homologous use only, as
reflected by the labeling, advertising, or other indications of the
manufacturer's objective intent;
     The manufacture of the HCT/P does not involve the
combination of the cells or tissues with another article, except for
water, crystalloids, or a sterilizing, preserving, or storage agent,
provided that the addition of water, crystalloids, or the sterilizing,
preserving, or storage does not raise new clinical safety concerns with
respect to the HCT/P; and
     Either
    [cir] The HCT/P does not have a systemic effect and is not
dependent upon the metabolic activity of living cells for its primary
function, or
    [cir] The HCT/P has a systemic effect or is dependent upon the
metabolic activity of living cells for its primary function, and is for
the following uses:
    [ssquf] Autologous,
    [ssquf] Allogeneic, in a first-degree or second-degree blood
relative, or
    [ssquf] Reproductive.
    If an HCT/P does not meet all of the criteria set forth under Sec.
1271.10(a), the HCT/P will be regulated as a drug, device, and/or
biological product under the Federal Food, Drug, and Cosmetic Act, and/
or section 351 of the PHS Act (42 U.S.C. 262).
    In certain circumstances as provided in Sec.  1271.15, an
establishment that manufactures HCT/Ps may be excepted from the
requirements in part 1271. For example, an establishment is excepted
from the requirements if it ``removes HCT/Ps from an individual and
implants such HCT/Ps into the same individual during the same surgical
procedure'' (Sec.  1271.15(b)).

II. Draft Guidances

    As part of its commitment to public outreach and to explain the
Agency's current thinking on the regulatory framework for HCT/Ps, FDA
has issued the following four draft guidances:
     Same Surgical Procedure Exception under Sec.  1271.15(b):
Questions and Answers Regarding the Scope of the Exception; Draft
Guidance for Industry (Same Surgical Procedure Exception Draft
Guidance);
     Minimal Manipulation of Human Cells, Tissues, and Cellular
and Tissue-Based Products; Draft Guidance for Industry and Food and
Drug Administration Staff (Minimal Manipulation Draft Guidance);
     Human Cells, Tissues, and Cellular and Tissue-Based
Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft
Guidance for Industry (Adipose Tissue Draft Guidance); and
     Homologous Use of Human Cells, Tissues, and Cellular and
Tissue-Based Products; Draft Guidance for Industry and Food and Drug
Administration Staff (Homologous Use Draft Guidance).
    The Same Surgical Procedure Exception Draft Guidance was published
in the Federal Register of October 23, 2014 (79 FR 63348), and provides
answers to common questions regarding the scope of the exception.
    The Minimal Manipulation Draft Guidance was published in the
03'Federal Register of December 23, 2014 (79 FR 77012), and provides
recommendations for meeting the Sec.  1271.10(a)(1) criterion of
minimal manipulation.
    The Adipose Tissue Draft Guidance was published in the Federal
Register of December 24, 2014 (79 FR 77414), and

provides those who manufacture and use adipose tissue with
recommendations for complying with the regulatory framework for HCT/Ps.
    Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of the Homologous Use Draft Guidance which provides
recommendations for applying the Sec.  1271.10(a)(2) homologous use
criterion, and is also announcing the reopening of the comment periods
on the Same Surgical Procedure Exception, Minimal Manipulation, and
Adipose Tissue Draft Guidances.

III. Purpose and Scope of the Public Hearing

    The purpose of this public hearing is to obtain comments on these
four draft guidances. FDA is seeking feedback, both general and
specific, from a broad group of stakeholders, including HCT/P
manufacturers, tissue establishments, biological and device product
manufacturers, health care professionals, clinicians, biomedical
researchers, and the public. For example, FDA would like comments on
the scope of each guidance, including the particular topics covered,
the particular questions posed, whether there are additional issues for
which they seek guidance, and whether FDA's recommendations for each
topic are sufficiently clear and consistent within and across documents
to provide meaningful guidance to stakeholders. In addition, FDA
welcomes any comments that will enhance the usefulness and clarity of
these documents.
    FDA recommends that comments exclude discussion of products which
do not meet the definition of an HCT/P, such as platelet rich plasma.
FDA also recommends that stakeholders coordinate comments when possible
in order to allow for presentation of a wide range of perspectives
within the allotted time of the meeting.

IV. Attendance and Registration

    The FDA Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Attendance is
free and will be on a first-come, first-served basis. Individuals who
wish to present at the public hearing must register by sending an email
to<EMAIL_ADDRESS>on or before January 8, 2016, and
provide complete contact information, including name, title,
affiliation, address, email, and phone number. Those without email
access may register by contacting Sherri Revell or Loni Warren
Henderson at<PHONE_NUMBER>. You should identify each guidance you wish
to comment on in your presentation so that FDA can consider that
information in organizing the presentations. Individuals and
organizations with common interests should consolidate or coordinate
their presentations and request time for a joint presentation. FDA will
do its best to accommodate requests to speak and will determine the
amount of time allotted for each oral presentation, and the approximate
time that each oral presentation is scheduled to begin. FDA will notify
registered presenters of their scheduled times, and make available an
agenda at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm on or before February 5,
2016. Once FDA notifies registered presenters of their scheduled times,
presenters should submit an electronic copy of their presentation to
<EMAIL_ADDRESS>by March 11, 2016.
    If you need special accommodations because of a disability, please
contact Sherri Revell or Loni Warren Henderson at<PHONE_NUMBER> at least
7 days before the meeting.
    A link to the live Web cast of this public hearing will be
available at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm on the day of the public
hearing. A video record of the public hearing will be available at
http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm following the meeting. A
video record of the public hearing will be available at the same Web
site address for 1 year.

V. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, accompanied by FDA
senior management from the Office of the Commissioner and the Center
for Biologics Evaluation and Research.
    Under Sec.  15.30(f), the hearing is informal and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (21 CFR part 10, subpart C). Under 21 CFR 10.205,
representatives of the electronic media may be permitted, subject to
certain limitations, to videotape, film or otherwise record FDA's
public administrative proceedings, including presentations by
participants. The hearing will be transcribed as stipulated in Sec.
15.30(b) (see section VI). To the extent that the conditions for the
hearing, as described in this document, conflict with any provisions
set out in part 15, this document acts as a waiver of those provisions
as specified in Sec.  15.30(h).

VI. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at www.regulations.gov and http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm. It may be viewed at the Division of Dockets Management,
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. A transcript will also be available in either hardcopy or on
CD-ROM, after submission of a Freedom of Information request. The
Freedom of Information office address is available on the Agency's Web
site at http://www.fda.gov.

    Dated: October 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27703 Filed 10-29-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: November 9, 2010 (Volume 75, Number 216)]
[Rules and Regulations]
[Page 68704]
[DOCID:fr09no10-12]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2010-0977]

Drawbridge Operation Regulations; Hackensack River, Jersey City,
NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Upper Hack Bridge at mile 6.9, across the Hackensack River, at
Secaucus, New Jersey. Under this temporary deviation the bridge may
remain in the closed position for two days in November to facilitate
bridge repairs.

DATES: This deviation is effective from 8 a.m. on November 18, 2010
through 6 p.m. on November 19, 2010.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2010-0977 and are available online
at http://www.regulations.gov, inserting USCG-2010-0977 in the
``Keyword'' and then clicking ``Search''. They are also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Mr. Joe Arca, Project Officer, First Coast Guard
District, telephone<PHONE_NUMBER>. If you have questions on viewing
the docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Upper Hack Bridge, across the Hackensack
River at mile 6.9 has a vertical clearance in the closed position of 8
feet at mean high water and 13 feet at mean low water. The existing
drawbridge operation regulations are listed at 33 CFR 117.723(d).
    The waterway has seasonal recreational vessels, and commercial
vessels of various sizes.
    The owner of the bridge, New Jersey Transit, requested a temporary
deviation to facilitate necessary electrical system upgrades and
asbestos removal at the bridge.
    Under this temporary deviation the Upper Hack Bridge, mile 6.9,
across the Hackensack River may remain in the closed position from 8
a.m. on November 18, 2010 through 6 p.m. on November 19, 2010. Vessels
that can pass under the bridge without a bridge opening may do so at
all times.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: October 27, 2010.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2010-28204 Filed 11-8-10; 8:45 am]
BILLING CODE 4910-15-P


[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Page 53896]
[FR Doc No: 2011-22054]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP11-2404-000.
    Applicants: KO Transmission Company.
    Description: KO Transmission Company submits tariff filing per
154.402: Annual Charge Adjustment Filing to be effective 10/1/2011.
    Filed Date: 08/22/2011.
    Accession Number: 20110822-5059.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 06, 2011.

    Docket Numbers: RP11-2405-000.
    Applicants: Questar Overthrust Pipeline Company.
    Description: Questar Overthrust Pipeline Company submits tariff
filing per 154.204: Correction to Forms of Agreement to be effective 9/
23/2011.
    Filed Date: 08/22/2011.
    Accession Number: 20110822-5111.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 06, 2011.

    Docket Numbers: RP11-2406-000.
    Applicants: Questar Overthrust Pipeline Company.
    Description: Questar Overthrust Pipeline Company submits tariff
filing per 154.204: Inactive Meters/Facilities to be effective 9/21/
2011.
    Filed Date: 08/22/2011.
    Accession Number: 20110822-5112.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 06, 2011.

    Docket Numbers: RP11-2407-000.
    Applicants: Questar Southern Trails Pipeline Company.
    Description: Questar Southern Trails Pipeline Company submits
tariff filing per 154.204: Inactive Meters/Facilities to be effective
9/21/2011.
    Filed Date: 08/22/2011.
    Accession Number: 20110822-5113.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 06, 2011.

    Docket Numbers: RP11-2408-000.
    Applicants: White River Hub, LLC.
    Description: White River Hub, LLC submits tariff filing per
154.204: Correction to Forms of Agreement to be effective 9/23/2011.
    Filed Date: 08/22/2011.
    Accession Number: 20110822-5114.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 06, 2011.

    Docket Numbers: RP11-2409-000.
    Applicants: White River Hub, LLC.
    Description: White River Hub, LLC submits tariff filing per
154.204: Inactive Meters/Facilities to be effective 9/21/2011.
    Filed Date: 08/22/2011.
    Accession Number: 20110822-5115.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 06, 2011.

    Docket Numbers: RP11-2410-000.
    Applicants: Gulf States Transmission LLC.
    Description: Gulf States Transmission LLC submits tariff filing per
154.402: Gulf States Transmission LLC ACA Tariff Update to be effective
10/1/2011.
    Filed Date: 08/22/2011.
    Accession Number: 20110822-5164.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 06, 2011.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: August 23, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-22054 Filed 8-29-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)]
[Notices]
[Pages 18292-18293]
[FR Doc No: 2017-07817]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0042; FRL-9960-66]

Pesticide Program Dialogue Committee; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: Pursuant to the Federal Advisory Committee Act, the
Environmental Protection Agency's (EPA's) Office of Pesticide Programs
is announcing a public meeting of the Pesticide Program Dialogue
Committee (PPDC) on May 3-4, 2017. This meeting provides advice and
recommendations to the EPA Administrator on issues associated with
pesticide regulatory development and reform initiatives, evolving
public policy and program implementation issues, and science issues
associated with evaluating and reducing risks from use of pesticides.

DATES: The meeting will be held on Wednesday, May 3, 2017, from 9:00
a.m. to 5:00 p.m., and Thursday, May 4, 2017, from 9:00 a.m. to 12:00
p.m.
    Agenda: A draft agenda will be posted on or before April 19, 2017.
    Accommodations Requests: To request accommodation of a disability,
please contact the person listed under FOR FURTHER INFORMATON CONTACT,
preferably at least 10 days prior to the meeting, to give EPA as much
time as possible to process your request.

ADDRESSES: The PPDC Meeting will be held at 1 Potomac Yard South, 2777
S. Crystal Drive, Arlington, VA, in the lobby-level Conference Center.
    EPA's Potomac Yard South Bldg. is approximately 1 mile from the
Crystal City Metro Station.

FOR FURTHER INFORMATION CONTACT: Dea Zimmerman, Office of Pesticide
Programs (LC-17J), Environmental Protection Agency, 77 W. Jackson
Boulevard, Chicago, IL 60604; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you work in an
agricultural settings or if you are concerned about implementation of
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); the
Federal Food, Drug, and Cosmetic Act (FFDCA); and the amendments to
both of these major pesticide laws by the Food Quality Protection Act
(FQPA) of 1996; the Pesticide Registration Improvement Act, and the
Endangered Species Act. Potentially affected entities may include, but
are not limited to: Agricultural workers and farmers; pesticide
industry and trade associations; environmental, consumer, and farm
worker groups; pesticide users and growers; animal rights groups; pest
consultants; State, local, and tribal governments; academia; public
health organizations; and the public. If you have questions regarding
the applicability of this action to a particular entity, consult the
person listed under FOR FURTHER INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2017-0042, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

II. Background

    The PPDC is a federal advisory committee chartered under the
Federal Advisory Committee Act (FACA), Public Law 92-463. EPA
established the PPDC in September 1995 to provide advice and
recommendations to the EPA Administrator on issues associated with
pesticide regulatory development and reform initiatives, evolving
public policy and program implementation issues, and science issues
associated with evaluating and reducing risks from use of pesticides.
The following sectors are represented on the current PPDC:
Environmental/public interest and animal rights groups; farm worker
organizations; pesticide industry and trade associations; pesticide
user, grower, and commodity groups; Federal and State/local/tribal
governments; the

general public; academia; and public health organizations.

III. How can I request to participate in this meeting?

    PPDC meetings are free, open to the public, and no advance
registration is required. Public comments may be made during the public
comment session of each meeting or in writing to the person listed
under FOR FURTHER INFORMATION CONTACT.

    Authority:  7 U.S.C. 136 et seq.

    Dated: March 28, 2017.
Richard P. Keigwin, Jr.,
Acting Director, Office of Pesticide Programs.
[FR Doc. 2017-07817 Filed 4-17-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 168 (Thursday, August 29, 2013)]
[Notices]
[Pages 53490-53491]
[FR Doc No: 2013-21035]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70247; File No. SR-CME-2013-16]

Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Regarding Modifications to Its OTC IRS Clearing Offering Including New
Fees and the Addition of Four New Currencies and Two New Rate Options

August 23, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Exchange Act'' or ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on August 16, 2013, Chicago Mercantile Exchange
Inc. (``CME'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change described in Items I, II and
III below, which Items have been prepared primarily by CME. 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

    CME is filing proposed rules changes that are limited to its
business as a derivatives clearing organization. More specifically, the
proposed rule changes would modify the fee schedule that applies to its
over-the-counter (``OTC'') interest rate swap (``IRS'') clearing
offering and would also make changes to current CME IRS rules to
facilitate the addition of four new currencies and two new rate
options.

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 self-regulatory organization
included statements concerning the purpose 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 self-regulatory organization 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

    CME is registered as a derivatives clearing organization with the
Commodity Futures Trading Commission and currently offers clearing
services for many different futures and swaps products. With this
filing, CME proposes to modify the fee schedule (the ``Fee Schedule'')
that applies to over-the-counter (``OTC'') Interest Rate Swaps
(``IRS'') cleared at CME and also proposes to make certain changes to
current CME Rule 90102E to facilitate the addition of four new
currencies to its IRS offering, specifically, the Czech Krona,
Hungarian Forint, Polish Zloty and the South African Rand, and to add
two new rate option for its IRS clearing offering, the Canadian Dollar
OIS and the USD-Federal Funds-H.15-LIBOR-BBA Rate Option. Finally, CME
will also be making certain conforming changes to its IRS Manual of
Operations for CME Cleared Interest Rate Swaps to make certain
operational changes to address the changes described above. Although
these changes will be effective on filing, CME plans to operationalize
the proposed fee changes on August 19, 2013 and the proposed changes to
Rule 90102E on August 26, 2013.
    The changes that are described in this filing impact fees and make
certain other adjustments as described above that are limited to CME's
business as a derivatives clearing organization clearing products under
the exclusive jurisdiction of the Commodity Futures Trading Commission
(``CFTC'') and do not materially impact CME's credit default swap
clearing business in any way. CME notes that it has already submitted
the proposed rule changes that are the subject of this filing to its
primary regulator, the CFTC, in CME Submissions 13-310, 13-313 and 13-
315.
    CME believes the proposed rule changes are consistent with the
requirements of the Exchange Act including Section 17A of the Exchange
Act.\3\ More specifically, the first aspect of the proposed rule
changes establish or change a member due, fee or other charge imposed
by CME under Section 19(b)(3)(A)(ii) \4\ of the Securities Exchange Act
of 1934 and Rule 19b-4(f)(2) \5\ thereunder. CME believes that the
proposed fee change is consistent with the requirements of the
Securities Exchange Act of 1934 and the rules and

regulations thereunder and, in particular, to 17A(b)(3)(D),\6\ in that
it provides for the equitable allocation of reasonable dues, fees and
other charges among participants. The proposed changes apply to all
market participants clearing IRS at CME. CME notes that it operates in
a highly competitive market in which market participants can readily
direct business to competing venues.
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    \3\ 15 U.S.C. 78q-1.
    \4\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \5\ 17 CFR 240.19b-4(f)(2).
    \6\ 15 U.S.C. 78q-1(b)(3)(D).
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    Second, the proposed rule changes also include changes to
facilitate the addition of four new currencies and two new rate option
choices associated with its IRS offering. These enhancements will offer
investors an expanded choice of products for IRS clearing and will
promote central clearing of swaps under the CFTC's jurisdiction. As
such, CME believes the changes are designed to promote the prompt and
accurate clearance and settlement of securities transactions and, to
the extent applicable, derivatives agreements, contracts, and
transactions, to assure the safeguarding of securities and funds which
are in the custody or control of the clearing agency or for which it is
responsible, and, in general, to protect investors and the public
interest consistent with Section 17A(b)(3)(F) of the Exchange Act.\7\
Furthermore, the proposed changes are limited in their effect to swaps
products offered under CME's authority to act as a derivatives clearing
organization. These products are under the exclusive jurisdiction of
the CFTC. As such, the proposed CME changes are limited to CME's
activities as a derivatives clearing organization clearing swaps that
are not security-based swaps; CME notes that the policies of the CFTC
with respect to administering the Commodity Exchange Act are comparable
to a number of the policies underlying the Exchange Act, such as
promoting market transparency for over-the-counter derivatives markets,
promoting the prompt and accurate clearance of transactions and
protecting investors and the public interest.
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    \7\ 15 U.S.C. 78q-1(b)(3)(F).
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    Because the proposed changes are limited in their effect to swaps
products offered under CME's authority to act as a derivatives clearing
organization, the proposed changes are also properly classified as
effecting a change in an existing service of CME that:
    (a) primarily affects the clearing operations of CME with respect
to products that are not securities, including futures that are not
security futures, and swaps that are not security-based swaps or mixed
swaps; and
    (b) does not significantly affect any securities clearing
operations of CME or any rights or obligations of CME with respect to
securities clearing or persons using such securities-clearing service.

As such, the changes are therefore consistent with the requirements of
Section 17A of the Exchange Act \8\ and are properly filed under
Section 19(b)(3)(A) \9\ and Rule 19b-4(f)(4)(ii) \10\ thereunder.
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    \8\ 15 U.S.C. 78q-1.
    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(4)(ii).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    CME does not believe that the proposed rule change will have any
impact, or impose any burden, on competition. The rule changes simply
modify CME's current IRS fee schedule to include two additional
maturity buckets for short-dated IRS and make changes to another CME
IRS rule to facilitate the addition of four new currencies and two new
rate options for IRS.

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

    CME has not solicited, and does not intend to solicit, comments
regarding this proposed rule change. CME has not received any
unsolicited written comments from interested parties.

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) \11\ of the Act and paragraphs (f)(2) and (f)(4)(ii) of
Rule 19b-4 \12\ 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.
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(2) and 17 CFR 240.19b-4(f)(4)(ii).
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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 No. SR-CME-2013-16 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CME-2013-16. 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 or
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of CME and on CME's
Web site at http://www.cmegroup.com/market-regulation/rule-filings.html.
    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-CME-2013-16
and should be submitted on or before September 19, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-21035 Filed 8-28-13; 8:45 am]
BILLING CODE 8011-01-P