[Federal Register Volume 87, Number 63 (Friday, April 1, 2022)]
[Rules and Regulations]
[Pages 18983-18985]
[FR Doc No: 2022-06922]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2022-0232]
RIN 1625-AA08

Special Local Regulation; Bonita Tideway, Brigantine, NJ

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary special local
regulation for navigable waters of the Bonita Tideway near Brigantine,
NJ. This action is needed to provide for the safety of life on these
navigable waters during a rowing competition on April 2, 2022, and
April 3, 2022. This rulemaking prohibits persons and vessels from being
in the regulated areas during the enforcement period unless authorized
entry by the Captain of the Port (COTP), Delaware Bay Zone or a
designated representative.

DATES: This rule is effective from 4 p.m. on April 2, 2022, through 1
p.m. April 3, 2022. This rule will be enforced from 4:30 p.m. to 7:30
p.m. on April 2, 2022, and from 7:30 a.m. to 12:30 p.m. on April 3,
2022.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0232 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 on this rule,
call or email MST1 Jennifer Padilla, Waterways Management Division,
Sector Delaware Bay, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background 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 sponsor required a change
of location from the planned event area near Atlantic City, NJ. The
sponsor notified the Coast Guard on March 17, 2022, of the location
move to Brigantine, NJ. Publishing an NPRM would be impracticable and
contrary to the public interest, because we must establish this special
local regulation by April 2, 2022, to ensure the safety of participants
and the public. Possible hazards include risks of participant injury or
death resulting from near or actual contact with non-participant
vessels traversing through the regulated area.
    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 because immediate action is needed to
provide for the safety of life on these navigable waters during a
rowing competition on April 2, 2022, and April 3, 2022.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70041. The Secretary has delegated ports and waterways authority, with
certain reservations not applicable here, to the Commandant via DHS
Delegation No. 00170.1(II)(70), Revision No. 01.2. The Commandant has
further delegated these authorities within the Coast Guard as described
in 33 CFR 1.05-1 and 6.04-6. The Coast Guard has determined that the
Stockton University Rowing competition could pose a risk to
participants or waterway users if normal vessel traffic were to
interfere with the event. Possible hazards include risks of participant
injury or death resulting from near or actual contact with non-
participant vessels traversing through the regulated areas. In order to
protect the safety of all waterway users, including event participants
and spectators, this rule establishes a special local regulation on
April 2, 2022, and April 3, 2022, within specified waters of Bonita
Tideway, Brigantine, NJ. This rule prevents vessels from entering,
transiting, mooring or anchoring within areas specifically designated
as regulated area during the periods of enforcement, unless authorized
by the Captain of the Port (COTP), or designated Event Patrol
Commander.

IV. Discussion of the Rule

    This rule establishes a special local regulation from 4:00 p.m. on
April 2, 2022, until 1 p.m. on April 3, 2022. The special local
regulation will be enforced from 4:30 p.m. to 7:30 p.m. on April 2,
2022, and from 7:30 a.m. to 12:30 p.m. on April 3, 2022. The regulated
area will cover all navigable waters of Bonita Tideway in Brigantine,
NJ, within a polygon bounded by the following: Originating on the
northern portion at approximate position latitude 39[deg]24'33'' N,
longitude 074[deg]22'28'' W; thence southwest across the Bonita Tideway
to the shoreline to latitude 39[deg]24'22'' N, longitude
074[deg]22'49'' W; thence southwest along the shoreline to

latititude 39[deg]23'49'' N, longitude 074[deg]23'33'' W; thence across
the Bonita Tideway to the shoreline at latitude 39[deg]23'43'' N,
longitude 074[deg]23'33'' W; thence north along the shoreline to the
point of origin. The duration of the regulated area is intended to
protect participants and waterway users in these navigable waters
before, during, and after the scheduled event. No vessel or person will
be permitted to enter the regulated area without obtaining permission
from the COTP or a 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 Executive Order 12866. Accordingly, this rule
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the size and
duration of the regulated area, which would impact a small designated
area of the Bonita Tideway. Vessels will be able to transit the
regulated area during the enforcement period as directed by the Event
Patrol Commander (PATCOM) or official patrol vessel.

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
regulated area 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
special local regulation lasting only 10 hours over two days that will
prohibit or restrict entry within the regulated area during a rowing
competition. It is categorically excluded from further review under
paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-
001-01, Rev. 1. A memorandum for record (MFR) 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 100

    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 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

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

    Authority:  46 U.S.C. 70041; 33 CFR 1.05-1.

0
2. Add Sec.  100.T05-0232 to read as follows:

Sec.  100.T05-0232  Special Local Regulation; Bonita Tideway,
Brigantine, NJ.

    (a) Regulated area. All navigable waters of the Bonita Tideway in
Brigantine, NJ, within the polygon bounded by the following:
Originating on the northern portion at approximate position latitude
39[deg]24'33'' N, longitude 074[deg]22'28'' W; thence southwest across
the Bonita Tideway to the shoreline to latitude 39[deg]24'22'' N,
longitude 074[deg]22'49'' W; thence southwest along the shoreline to
latititude 39[deg]23'49'' N, longitude 074[deg]23'33'' W; thence across
the Bonita Tideway to the shoreline at latitude 39[deg]23'43'' N,
longitude 074[deg]23'33'' W; thence north along the shoreline to the
point of origin.
    (b) Definitions. The following definitions apply to this section:
    (1) Captain of the Port Representative or COTP Representative means
a commissioned, warrant, or petty officer of the Coast Guard designated
by name by the Captain of the Port to verify an event's compliance with
the conditions of its approved permit.
    (2) Event Patrol Commander or Event PATCOM means any vessel
assigned or approved by the respective Captain of the Port with a
commissioned, warrant, or petty officer on board and displaying a Coast
Guard ensign, or any state or local law enforcement vessel approved by
the Captain of the Port in accordance with current local agreements.
    (3) Non-participant means a person or a vessel not registered with
the event sponsor either as a participant or an official patrol vessel.
    (4) Official patrol vessel or official patrol means any vessel
assigned or approved by the respective Captain of the Port with a
commissioned, warrant, or petty officer on board and displaying a Coast
Guard ensign, or any state or local law enforcement vessel approved by
the Captain of the Port in accordance with current local agreements.
    (5) Participant means any person or vessel registered with the
event sponsor as participating in the event or otherwise designated by
the event sponsor as having a function tied to the event.
    (c) Patrol of the marine event. The COTP may assign one or more
official patrol vessels, as described in Sec.  100.40, to the regulated
event. The Event PATCOM will be designated to oversee the patrol. The
patrol vessel and the Event PATCOM may be contacted on VHF-FM Channel
16. The Event PATCOM may terminate the event, or the operation of any
vessel participating in the marine event, at any time if deemed
necessary for the protection of life or property.
    (d) Special local regulations--(1) Controls on vessel movement. The
Event PATCOM, COTP Representative, or official patrol vessel may forbid
and control the movement of all persons and vessels in the regulated
area(s). When hailed or signaled by an official patrol vessel, the
person or vessel being hailed must immediately comply with all
directions given. Failure to do so may result in expulsion from the
area, citation for failure to comply, or both.
    (2) Directions, instructions, and minimum speed necessary. (i) The
operator of a vessel in the regulated area must stop the vessel
immediately when directed to do so by a COTP Representative or official
patrol vessel and then proceed only as directed.
    (ii) A person or vessel must comply with all instructions of the
Event PATCOM, COTP Representative, or official patrol vessel.
    (iii) A non-participant must contact the Event PATCOM or an
official patrol vessel to request permission to either enter or pass
through the regulated area. If permission is granted, the non-
participant may enter or pass directly through the regulated area as
instructed by the Event PATCOM or official patrol vessel at a minimum
speed necessary to maintain a safe course that minimizes wake and
without loitering.
    (3) Postponement or cancellation. The COTP or Event PATCOM may
postpone or cancel a marine event at any time if, in the COTP's sole
discretion, the COTP determines that cancellation is necessary for the
protection of life or property.
    (e) Enforcement period. This section will be enforced from 4:30
p.m. to 7:30 p.m. on April 2, 2022, and from 7:30 a.m. to 12:30 p.m. on
April 3, 2022.

    Dated: March 29, 2022.
Jonathan D. Theel,
Captain, U.S. Coast Guard, Captain of the Port, Delaware Bay.
[FR Doc. 2022-06922 Filed 3-31-22; 8:45 am]
BILLING CODE 9110-04-P


1 Methyl Isothiocyanate ( MITC):

Weight of the Evidence for Use of Human Eye Irritation Study Anna Lowit, Ph. D.

Anna Lowit, Ph. D.

U. S. EPA U. S. EPA Office of Pesticide Programs Office of Pesticide Programs May 3, 2006 May 3, 2006 2 Overview Overview

Key exposure pathways for soil fumigants

MITC toxicology database

Design and results of the MITC human eye irritation study

Incorporation of MITC human eye irritation in risk assessment 3 Overview: Soil Fumigants Overview: Soil Fumigants

OPP is evaluating the risk from the soil fumigants:

 Methyl bromide  Methyl iodide  Chloropicrin  Metam sodium & Metam potassium ( degrade to MITC)

 Dazomet ( degrades to MITC)

Public Technical briefing for Soil Fumigants in July, 2005 4 Overview: MITC Overview: MITC

Exposure pathways  Can be used directly to treat wood poles  Key degradate of metam sodium, metam potassium and dazomet   It is believed that MITC that provides the fumigating properties   Metam sodium and metam potassium are used to treat sewage systems   Major pathway: Metam sodium, metam potassium, and dazomet are used as a soil fumigants 5 Human Health Assessment:

Residential Bystander Exposure Wind blows Wind blows emissions from emissions from a treated field to a a treated field to a receptor of concern receptor of concern ( e. g., house or school)

( e. g., house or school)

Wind direction Wind direction Occurs from known sources, single Occurs from known sources, single applications used in assessment applications used in assessment 6 MITC: Toxicity Profile MITC: Toxicity Profile  Animal Animal

Majority of studies via oral route

Limited animal database via the inhalation route  28 day rat inhalation study   6.8 ppm: clinical signs ( eyelid closure, somnolence, and ruffled fur from the 3 rd day of exposure onwards)

  34 ppm: nasal pathology ( metaplasia of respiratory epithelium and atrophy of the olfactory epithelium).

 Acute lethality study in rats   Approx. 80 ppm: clinical signs ( rales) and increased lung weights Animal database does not provide characterization for the progression of possible toxic effects from acute inhalation exposure 7 MITC: Toxicity Profile MITC: Toxicity Profile  Human Human

Incident Data  Provide support for irritating properties of MITC   Headache, eye, skin, nose, and throat irritation, nausea, dizziness,

coughing, shortness of breath, diarrhea, and chest tightness.

 Insufficient exposure data prevents use of incident data in quantitative risk assessment

Human Odor Threshold Study  Geometric mean of 1.7 ppm ( ranged from 0.2 to 8 ppm)

 Odor threshold less sensitive than results of eye irritation study   Thus, less useful in risk assessment

Human Eye Irritation Study  Used in EPA s risk assessments in 2004 & 2005 for estimation of acute ( 1 day) bystander and worker risk 8 Study Design: Human Eye Irritation Study Design: Human Eye Irritation

70 individuals ( 38 males, 32 females)

Mean age of 32 years ( range, 18 67 years; median age, 28 years)

Information about individual subjects:

 Some individuals were tested for more than one exposure duration.

 The subject identification numbers were changed with each session  Can not determine which subjects were included repeatedly  Sex and age unknown 9 Study Design: Parameters Measured Study Design: Parameters Measured

Eyes only  specialized goggle system

Subjective estimation of irritation using the " Likert"

scale    No irritation  to   so much that you feel you should end the exposure

 Mid level similar to that for cutting up an onion;

Blink rate as measured by electromyography

Photographs of the subjects' eyes prior to and after exposure to evaluate degree of redness and swelling

Effect upon visual acuity using a standard eye chart

Tear production 9 3.3 ppm 9 1.9 ppm 9 0.6 ppm 0 Acetic acid control 10 Air only control 4/ 18/ 95   4/ 26/ 95 14 minute 9 0.8 ppm 12 0.23 ppm 14 Acetic acid control 12 Air only control 3/ 13/ 95   3/ 31/ 95 4 hour trial 16 0.22 ppm 7 Acetic acid control 12 Air only control 12/ 8/ 94   1/ 9/ 95 8 hour trial Number of subjects Concentration( s)

Tested Dates Duration Study Design: Treatment Groups Study Design: Treatment Groups 11 Results: Human Eye Irritation Results: Human Eye Irritation

Tearing  No statistically positive tearing responses were observed at any concentration or duration

Visual acuity and photographs  Data not provided in report  Director concludes these did not provide " any meaningful information on chemical exposure" 12 Results: Subjective Scoring Results: Subjective Scoring N/ A 0.22 ppm 8 hour 0.8 ppm 0.22 ppm 1 4 hour 1.9 ppm 0.6 ppm 4 14 min N/ A 3.3 ppm 1 min LOAEL NOAEL Duration Most subjects scored < 50% at most time points.

Some reached scores > 75% 13 Results: Blinking Rate Results: Blinking Rate N/ A 0.22 ppm 8 hour 0.8 ppm 0.22 ppm 1 4 hour 3.3 ppm 1.9 ppm 4 14 min N/ A 3.3 ppm 1 min LOAEL NOAEL Duration 14 Overall: Human Eye Irritation Overall: Human Eye Irritation

Weaknesses:

 Information about subjects limits ability to:

° consider age or gender sensitivity ° within subject variation  Eye photographs and visual acuity not provided  Positive control data not included in study  Goggle study only 15

Strengths:

 Multiple exposure concentrations  Durations ranging from 1 min to 8 hours  Subject number  Both sexes included  Objective and subjective measurements Overall: Human Eye Irritation Overall: Human Eye Irritation 16

1 minute: NOAEL is 3.3 ppm  Lack of response in any parameter tested.

4 14 minutes: NOAEL is 0.6 ppm  Responses on the Likert subjective scale at 1.9 ppm.

1 8 hours: NOAEL is 0.22 ppm  Responses on the Likert subjective scale at 0.8 ppm at 1 4 hours  Eyeblink responses at 2 and 3 hours Overall: Human Eye Irritation Overall: Human Eye Irritation


[Federal Register Volume 85, Number 18 (Tuesday, January 28, 2020)]
[Notices]
[Pages 4997-4999]
[FR Doc No: 2020-01342]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5606]

Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use--
Premarket Notification (510(k)) Submissions; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Arthroscopy Pump
Tubing Sets Intended for Multiple Patient Use--Premarket Notification
(510(k)) Submissions.'' FDA has developed this draft guidance document
to assist in the preparation of premarket notification submissions
(510(k)) for arthroscopy pump tubing sets intended for multiple patient
use. This draft guidance outlines the device design considerations,
risk mitigation strategies, and testing recommendations for arthroscopy
pump tubing sets intended for multiple patient use. This draft guidance
document also clarifies the terminology used to describe arthroscopy
pump tubing sets intended for multiple patient use. This draft guidance
is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by March 30, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-5606 for ``Arthroscopy Pump Tubing Sets Intended for
Multiple Patient Use--Premarket Notification (510(k)) Submissions.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use--
Premarket Notification (510(k)) Submissions'' to the Office of Policy,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Cal Rabang, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4633, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
and FDA staff entitled ``Arthroscopy Pump Tubing Sets Intended for
Multiple Patient Use--Premarket Notification (510(k)) Submissions.''
FDA has developed this draft guidance document to assist in the
preparation of premarket notification submissions (510(k)) for
arthroscopy pump tubing sets intended for multiple patient use. These
devices are designed to deliver irrigation fluid to the surgical site,
such as knee, shoulder, hip, elbow, ankle, and wrist joint cavities,
during arthroscopic procedures. In arthroscopic procedures, clinicians
often use a single source of irrigation fluid for multiple patients
without replacing the source of irrigation fluid or replacing/
reprocessing the irrigation tubing system between patients. This
practice may increase the risk of cross-contamination between patients
and subsequent iatrogenic infection because the irrigation system can
become contaminated with patient fluids that travel back through the
irrigation tubing (``backflow''). FDA has received reports of backflow
of patient fluids, which raises the question of potential for disease
transmission when using irrigation and tubing systems in such a manner
on multiple patients.
    When finalized, this guidance is intended to provide
recommendations for information to include in premarket notifications
(510(k)s) for arthroscopy pump tubing sets intended for multiple
patient use. This guidance will outline device design considerations,
risk mitigation strategies, and testing recommendations for these
devices, and will also clarify the terminology used to describe
arthroscopy pump tubing sets intended for multiple patient use.

II. Significance of Guidance

    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 ``Arthroscopy
Pump Tubing Sets Intended for Multiple Patient Use--Premarket
Notification (510(k)) Submissions.'' 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.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov. Persons unable to download an
electronic copy of ``Arthroscopy Pump Tubing Sets Intended for Multiple
Patient Use--Premarket Notification (510(k)) Submissions'' may send an
email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document. Please use the document number 1500066 to
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The
collections of information in the following FDA

regulations have been approved by OMB as listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
          21 CFR part                     Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket Notification.       0910-0120
801............................  Medical Device Labeling       0910-0485
                                  Regulations.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
------------------------------------------------------------------------

    Dated: January 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01342 Filed 1-27-20; 8:45 am]
 BILLING CODE 4164-01-P


A. As explained in the ICR, EPA decided to exclude the cost of providing Tier 1 hazard data from the estimated cost of the program because the Tier 1 hazard data is the same data that the sponsor developed for the HPV Challenge Program, which is accounted for in a separate ICR ( 1139). It should be noted that EPA is including the cost of developing Tier 1 Exposure Assessments, Risk Assessments, and Data Needs Assessments, because these three assessments are not required by the HPV Challenge Program and they represent a separate effort specifically for VCCEP.

7. Q. SOCMA commented that toxicity testing protocols that are still being developed for the VCCEP should be subject to rigorous peer review to maximize their utility.

A. EPA is not developing new toxicity testing protocols for VCCEP, but has recommended that the sponsors follow the toxicity test guidelines which the TSCA program has used in its regulatory programs over the last 10 to 20 years. These test guidelines have all been subjected to public review and comment.  4

8. Q. SOCMA and ACC commented that EPA has asked for too much information on exposure and that the requested information should be limited to that information which is useful and necessary to a risk characterization.

A. Some guidance was provided on this question at the Exposure Workshop held in December 2001. Answering the question " have potential risks to children been adequately characterized" will determine the depth of the assessment needed. For Tier 1 of VCCEP, sponsors should develop a screening level assessment of readily available exposure information, including data on exposures outside the chain of commerce. Once a screening level assessment of exposure is developed, the sponsor can then determine whether a more thorough evaluation of exposure is suggested, even at Tier 1, based on presence in human tissues, availability of higher tier toxicological data, or other information. EPA asked the sponsors to bring forth all readily available exposure information to put the totality of exposures into context, and then focus on those exposures which are most significant and relevant to children. EPA believes that it is important to initially bring forth as much exposure information as possible to assure that all possible exposures have been considered. The sponsor should then explain why some exposures are not significant or sufficiently relevant to children to warrant a quantitative estimate or evaluation which could be used in a risk assessment, and then focus his detailed evaluations on those exposures which he considers to be significant and relevant to children.

9. Q. SOCMA commented that a sponsor may not have access to some exposure information or it may be CBI.

A. In such cases where a sponsor is aware of but cannot access certain exposure information, the sponsor should note that he is aware of additional data or information and describe the reason that the information was not included in the assessment. If some information is CBI, the sponsor should claim it as such in his submission as explained in the Federal Register notice announcing VCCEP.

10. Q. SOCMA commented that the sponsor should be allowed the discretion to do a qualitative instead of a quantitative evaluation of exposure since this is the approach most often used by the public.

A. To meet the objective of VCCEP of characterizing the risks to children from exposure to certain chemicals, that risk must first be assessed for each chemical. A risk assessment cannot be developed using only qualitative descriptions of exposure. Quantitative exposure data must be provided and used in conjunction with health effects data to develop a risk assessment. In communicating the risk assessment results to the public, qualitative descriptions can be used in characterizing risk to make it more understandable to the public. This is stated in the Federal Register notice announcing VCCEP.

11. Q. ACC commented that the formats presented by EPA at the Exposure workshop are overly prescriptive and require far more information than is needed to meet the objectives of the VCCEP. Expressing a similar concern, SOCMA commented that sponsors should be given the flexibility to determine which information is necessary for characterizing potential exposures.  5

A. A thorough description of exposure requires information on a number of parameters ( frequency, duration, levels, routes, population exposed, etc.) to be meaningful and useful in a risk assessment. The Federal Register notice announcing VCCEP attempted to list all such parameters, and the sponsors should attempt to provide as much of that information as possible or explain why certain parameters of exposure do not apply to the situation being described. The formats that EPA presented at the Exposure workshop represented EPA's perspectives on how exposure information could best be submitted by VCCEP sponsors. The formats are not required and ultimately it is up to the submitter to determine how to present his exposure assessment.

12. Q. ACC commented that a meaningful integration of hazard and exposure information at each tier is a key feature of the pilot and should be relied on to inform the need for additional data from the next tier.

A. EPA agrees with ACC and believes that the structure and operational procedures which define the pilot VCCEP will assure that the integration of health and exposure data at each tier to produce a risk assessment will be the most meaningful way to identify what, if any, additional data may still be needed to fully characterize a chemical's risk to children.

13. Q. ACC commented that the determination that a pilot chemical should proceed to the next tier should not mean that the chemical has been or will be found to present significant health risks.

A. EPA agrees and intends to state in any future decision, as it has up to this point, that a pilot chemical should proceed to the next tier because EPA has determined that the available data are not sufficient to completely assess risk to children.

14. Q. The Physicians' Committee for Responsible Medicine ( PCRM) commented that studies in animals of metabolism and pharmacokinetics, developmental neurotoxicity, and genetic toxicity cannot predict or contribute to an understanding of health effects in humans or specifically, for the latter two, children.

A. EPA uses whole animal tests for metabolism/ pharmacokinetics for selected chemicals because these tests offer basic information on these two endpoints. In the case of VCCEP this information can used to infer information on the metabolism/ pharmacokinetics of the VCCEP chemicals in children. Developmental neurotoxicology tests are used to determine the potential neurotoxicity of selected chemicals throughout development and maturation of the fetus and new born animal. Experts in the field have concluded that the results are predictive of developmental neurotoxicolgy in children. The genetic toxicology tests used in the VCCEP, i. e., the Ames assay, the in vitro test for chromosomal aberrations and either the in vivo test for chromosomal aberrations or the in vivo micronucleus assay will serve as potential triggers, along with all other relevant information, for a cancer bioassay. The relevance of this use of genetic toxicology testing to humans has been widely accepted for many years.

15. Q. PCRM commented that in vivo genetic toxicity tests [ chromosomal aberrations or micronucleus] should not be conducted because non animal tests have been accepted by  6

government regulators internationally for more than 20 years as screening tests for gene mutation, chromosomal aberrations, and sister chromatid exchange.

A. When testing for mutagenicity as a separate endpoint, EPA uses an in vitro test for bacterial mutation, an in vitro test for gene mutation in mammalian cells in culture, and an in vitro test for chromosomal aberrations in its first tier testing for hazard identification. However, as stated above in 14. A, the mutagenicity tests used in the VCCEP are not to be used to determine mutagenic potential as a separate endpoint but rather as potential triggers, along with all other relevant information, for a cancer bioassay. The in vivo assays mentioned above, i. e. the in vivo chromosomal aberration assay and the in vivo micronucleus assay, are there to lend support to the results of the in vitro testing ( i. e. the Ames Assay and the in vitro assay for chromosomal aberrations.)

16. Q. PCRM commented that EPA should expand its burden estimate of the ICR, beyond cost and hours, to include the number of animals used in tests for toxicity.

A. The ICR developed for VCCEP is responsive to the burden concerns identified by OMB which are limited to those of cost and hours. Nevertheless, the ICR does cite the test guideline to be used for each toxicity test in VCCEP and each test guideline indicates the number of animals necessary to show a statistically valid, dose response relationship. What is not known, at this time, is which tests at any of the three tiers that the pilot VCCEP chemicals will undergo. EPA believes that most of the pilot chemicals have many of the tests completed and that the pilot VCCEP will focus more on data evaluation than data development. Given so many uncertainties, EPA cannot provide a meaningful estimate of the number of animals that may ultimately be used in future toxicity tests for VCCEP.

17. Q. PCRM commented that EPA should develop specific provisions to dramatically reduce the number of animals used in VCCEP, as it has done for the other burdens of cost and hours.

A. The features of VCCEP which should reduce the burden of cost and hours, namely tiered and triggered testing, will do so by an overall reduction in the amount of testing and consequently a reduction in the number of animals used in VCCEP. The selection of chemicals for the pilot VCCEP which are data rich will also contribute to a low amount of new testing. Also, as stated the Federal Register notice announcing VCCEP, EPA is committed to reducing, refining, and replacing animal testing when valid alternatives exist, and EPA works with the Interagency Coordinating Committee for the Validation of Alternative Methods and with OECD to ensure the scientific acceptability of alternative test methods. Beyond this, EPA cannot arbitrarily reduce the number of animals to be used in a specific test since it already is the least number of animals which will show a statistically valid, dose response relationship.

18. Q. ACC and SOCMA contend that laboratory testing costs are underestimated. ACC believes that EPA's test cost estimates are too low, possibly even half or a quarter of the actual cost for some tests. ACC also mentions that HPV Challenge Program testing and animal rights issues will strain lab capacities and cause a sharp rise in costs, on the order of 5% 10% annually.  7

A. Laboratory cost estimates used by OPPT are developed by lab personnel who carefully break down the tasks required for each protocol, and then generate estimates of time and cost for task. In response to the claim that EPA underestimated laboratory testing costs, EPA contacted a small number of laboratories to review the prices charged for testing. EPA found that all of EPA's estimates were within the range of prices obtained. While EPA's contacts were far from exhaustive, the responses indicated that for every test in the VCCEP battery except one, at least one laboratory contacted charges less than the EPA estimate. For some tests, EPA estimates were notably higher. Given this, EPA will not alter the test costs used in the VCCEP ICR.

As for the claim that test costs will rise by as much as 30% over the next three years, EPA's estimates are in year 2000 dollars, and having investigated lab capacity recently, EPA finds no basis for the assertion that lab costs will increase substantially over the general rate of inflation in the near future.

19. Q. ACC claims that EPA's estimates of industry wages rates are too low. ACC points out that EPA used a wage rate based on all goods producing industries in the VCCEP ICR, and claims that the chemical industry pays 26 33% more than manufacturers as a whole. ACC also claims that EPA used a 17% benefits rate, when ACC data indicates that figure to be 26%. In addition, ACC claims that clerical support, assumed to be 10% of the burden in the ICR, is unrealistically high.

A. ACC failed to provide a source for the claim that wage rates in the chemical sector are higher than those for manufacturers as a whole, but, EPA did find evidence from the Bureau of Labor Statistics ( BLS) that the average hourly earnings for all non supervisory workers in the chemical sector is indeed 17% higher for all workers ($ 18.87 vs. $ 16.17 in 2002, BLS table B3) than those in all goods producing industries. However, EPA does not rely on the average hourly rates to calculate wage rates. The wage rates used by EPA include supervisory employees, specifically professional workers ( attorneys, engineers, accountants) and thus, represent a highly skilled professional mix and a relatively high wage rate. EPA used 40 45% as the benefits rate in wage calculations, significantly higher than the 26% ACC suggests. ACC believed that EPA's benefits rate was 17%, however, this is actually an overhead rate that EPA includes in its wage estimate along with a benefits rate. Finally, ACC indicates that there is a low level of secretarial support in industry. While EPA accepts that this level of support has changed throughout the years, it does not accept the claim that highly paid managerial and technical labor will perform the basic office tasks such as typing, copying, filing, and mailing resulting from the collection.

Recent analysis by EPA's TRI program has indicated that the estimates used by EPA are significantly higher than the 90th percentile BLS wages for managerial and technical labor, indicating that in creating the wage rates, EPA used an extremely skilled mix of professions, far in excess of what is currently found in industry, according to the BLS. The same analysis suggests revising those labor rate estimates downward 48% for managerial labor, 43% for technical labor, and 23% for clerical labor.

Given these factors, and in the absence of any suggestions by ACC as to appropriate wage rates, EPA contends that the wage rates included in the VCCEP ICR are, if anything, too high.  8

20. Q. ACC claims that EPA's estimates of the costs associated with preparing exposure assessments are too low. While providing no estimates of what burdens might be expected, ACC claims that EPA estimates of burden for conducting exposure assessments do not adequately account for the complexity of the task.

A. As explained in the ICR, EPA solicited information from exposure assessors within the Agency and in private practice to determine the burden associated with the tasks required. While the responses varied greatly, the average response was 2600 2700 total hours for all three tiers. EPA stands by this estimate.

21. Q. ACC notes that additional costs associated with the program are omitted. ACC points out that ACC co sponsored a workshop in preparation for VCCEP, will be involved in peer review, and will need extra time to understand the process of this pilot program. None of these costs are included in the ICR.

A. With any EPA program, organizations may undertake activities in response to the EPA programs that do not necessarily constitute burden of the collection. The ICR process only requires accounting of burden associated with those tasks that are completed by respondents and are part of the VCCEP, as outlined in the Federal Register. EPA has considered costs of peer consultation in its estimates, and ACC has shown no evidence to suggest that EPA's estimates are inadequate other than EPA's exclusion of costs for travel. EPA has developed an estimate of these costs to cover travel by sponsoring companies or their consultants to such meetings ( see response to comment # 25).

22. Q. SOCMA notes that EPA assumed that only a portion of the 23 chemicals in the program will go on to Tier 2 and 3 evaluation. SOCMA contends EPA should estimate that all chemicals complete all tiers..

A. EPA disagrees with SOCMA's contention that all of the chemicals should be assumed to complete all tiers in the VCCEP. As SOCMA accurately notes earlier in their comments ( see comment # 4 and the EPA response above), the tiered approach requires that upper tiers be triggered by results of the lower tiers, an approach that " maximizes utility and minimizes waste." While specifying the number of chemicals that will enter the upper tiers is arbitrary, the expectation that all chemicals will enter all tiers, particularly in the three year period of the ICR, is unsupportable.

23. Q. SOCMA notes that EPA did not include fees paid to consultants by industry in burden calculations.

A. EPA has calculated wage costs associated with the various activities in the collection and has assumed that these activities will be conducted within the respondent organization, rather than by consultants. EPA has not included separate costs for consultants because it believes that industry will hire outside consultants if the costs are equal to or less than the costs of paying its  9

own employees to perform the same activity. Therefore, EPA's estimates of cost are believed to be adequate whether work is conducted in house or by a consultant.

Additionally, under OMB guidance for developing ICR estimates, Agencies must consider the time burden of activities requiring the effort of employees, partners, and associates of the respondent. However, the Agency must only consider the financial burden of activities conducted by outside consultants. Therefore, there is no need to include a burden hour estimate for consultant activities. If EPA did assume that activities were performed by consultants rather than in house, it would need to reduce the current estimate of burden hours accordingly.

24. Q. SOCMA suggests that EPA's method for estimating non reporting costs should be simplified. SOCMA estimates that the administrative cost for testing programs is 15 20%.

A. EPA's method for estimating administrative non reporting costs is straightforward and accurately reflects the distinction between reporting costs and non reporting costs, as required by the ICR process. EPA's estimate of 25% for administrative costs for testing programs is higher than the 15 20% suggested by SOCMA.

25. Q. SOCMA notes that travel costs to public meetings are not included.

A. Travel costs to and from public meetings are a valid cost of the VCCEP. EPA will include $ 1,000 per person to cover potential costs of travel to public meetings.