A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs, 63482-63484 [2016-22132]

Download as PDF sradovich on DSK3GMQ082PROD with NOTICES 63482 Federal Register / Vol. 81, No. 179 / Thursday, September 15, 2016 / Notices Number of Respondents and Responses: 50 respondents; 50 responses. Estimated Time per Response: 20 minutes. Frequency of Response: On occasion reporting requirement. Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is Section 154(i) of the Communications Act of 1934, as amended. Total Annual Burden: 17 hours. Total Annual Cost: $63,750. Privacy Act Impact Assessment: No impact(s). Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information. 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The statutory authority for this collection of information is contained in Sections 4(i), 11, 303(g), 303(r), and 332(c)(7) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 161, 303(g), 303(r), 332(c)(7). Total Annual Burden: 100 hours. Annual Cost Burden: None. Privacy Act Impact Assessment: No impact(s). Nature and Extent of Confidentiality: There is no need for confidentiality with this collection. Needs and Uses: When a frequency is shared by more than one system, automatic monitoring equipment must be installed at the base station to prevent activation of the transmitter when signals of co-channel stations are present and activation would interfere with communications in progress. Licensees may operate without the monitoring equipment if they have obtained the consent of all co-channel licensees located within a 120 kilometer (75 mile) radius of the interconnected base station transmitter. A statement must be submitted to the Commission indicating that all co-channel licensees have consented to operate without the monitoring equipment. This information is necessary to ensure that licensees comply with the Commission’s technical and operational rules, and to prevent activation of the transmitter when signals of co-channel stations are present and could possibly interfere with communications in process. Federal Communications Commission. Marlene H. Dortch, Secretary, Office of Secretary. [FR Doc. 2016–22194 Filed 9–14–16; 8:45 am] BILLING CODE 6712–01–P FEDERAL MARITIME COMMISSION Sunshine Act Meeting Federal Maritime Commission. TIME AND DATE: September 20, 2016; 10:00 a.m. PLACE: 800 N. Capitol Street NW., First Floor Hearing Room, Washington, DC. STATUS: The first portion of the meeting will be held in Open Session; the second in Closed Session. MATTERS TO BE CONSIDERED: AGENCY HOLDING THE MEETING: PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 Open Session 1. Briefing by Commissioner Maffei on U.S./Japan Bilateral Discussions 2. Staff Briefing on Foreign-based NVOCC Registration Renewal Process (Form FMC–65) Closed Session 1. Staff Briefing on Hanjin Shipping Bankruptcy and Shipping Disruptions 2. Staff Briefing on the Maersk/MSC Vessel Sharing Agreement, FMC Agreement No. 012293 CONTACT PERSON FOR MORE INFORMATION: Rachel E. Dickon, Assistant Secretary, (202) 523–5725. Rachel E. Dickon, Assistant Secretary. [FR Doc. 2016–22299 Filed 9–13–16; 4:15 pm] BILLING CODE 6730–AA–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [CDC–2016–0090, Docket Number NIOSH 288–A] A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of public meeting and request for public comment on a draft testing protocol. AGENCY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces a public meeting concerning a universal closed system drug-transfer device (CSTD) testing protocol entitled, A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs, http://www.cdc.gov/niosh/topics/ hazdrug/default.html/. This is an opportunity for public comment on the protocol, the proposed list of surrogates, and to respond to NIOSH questions regarding the protocol. To view the protocol and related materials, visit www.regulations.gov and enter CDC–2016–0090 in the search field and click ‘‘Search.’’ SUMMARY: E:\FR\FM\15SEN1.SGM 15SEN1 Federal Register / Vol. 81, No. 179 / Thursday, September 15, 2016 / Notices Table of Contents I. Background II. Protocol III. Public Meeting The public meeting will be held on November 7, 2016, 9:00 a.m.–3:00 p.m. Eastern Time, or until after the last public commenter has spoken, whichever occurs first. Electronic or written comments must be received by December 7, 2016. ADDRESSES: The public meeting will be held at the Alice Hamilton Laboratories, Conference Room C, 5555 Ridge Avenue, Cincinnati, OH 45213. Virtual attendance using LiveMeeting and audio conference will be available. You may submit written comments, identified by CDC–2016–0090 and Docket Number NIOSH 288–A, by either of the following two methods: • Federal eRulemaking Portal: www.regulations.gov. Follow the instructions for submitting comments. • Mail: National Institute for Occupational Safety and Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C–34, Cincinnati, Ohio 45226–1998. Instructions: All information received in response to this notice must include the agency name and docket number [CDC–2016–0090; NIOSH 288–A]. All relevant comments received will be posted without change to http:// www.regulations.gov, including any personal information provided. All information received in response to this notice will also be available for public examination and copying at the NIOSH Docket Office, 1150 Tusculum Avenue, Room 155, Cincinnati, OH 45226–1998. FOR FURTHER INFORMATION CONTACT: Deborah V. Hirst, NIOSH, Division of Applied Research and Technology, Alice Hamilton Laboratories, 1090 Tusculum Ave., MS R–5, Cincinnati, OH 45226. (513) 841–4141 (not a toll free number) or email DHirst@cdc.gov. SUPPLEMENTARY INFORMATION: I. Background: Closed system drugtransfer devices (CSTDs) are generally available in two design types: (1) One that uses a physical barrier to block the unintended release of drug into the surrounding environment or the intake of environmental contaminants into the sterile drug pathway and (2) one that uses air cleaning or filtration technologies to prevent the unintended release of drug into the surrounding environment or the intake of environmental contaminants into the sterile drug pathway. On September 8, 2015, NIOSH released the draft test protocol, A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of sradovich on DSK3GMQ082PROD with NOTICES DATES: VerDate Sep<11>2014 17:34 Sep 14, 2016 Jkt 238001 Hazardous Drugs, for public review. The draft protocol was developed by NIOSH to evaluate how containment effective the physical barrier-type CSTDs were as an indicator of how protective they would be at preventing hazardous drug escape from the closed system. After significant public comment and several inquiries, on January 19, 2016, NIOSH published a Request for Information for the development of a test protocol to evaluate the performance of CSTDs that adopt air-cleaning or filtration technologies. Since the Federal Register docket for both the draft protocol and the request for information closed on March 8, 2016, NIOSH has done the following: a. Generated a list of surrogates to test both types of CSTDs. b. Met individually with CSTD manufacturers who requested informal meetings to discuss the current draft protocol and/or items NIOSH should consider in developing a new performance test protocol for aircleaning CSTDs. This was in answer to NIOSH’s Request for Information question #12, Are you interested in being a collaborative partner with NIOSH on the development of an air cleaning or filtration technologies CSTD test protocol? c. Drafted a new universal performance test protocol applicable to both barrier and air-cleaning types of CSTDs. II. Protocol: The proposed protocol will apply to both barrier and aircleaning types of CSTDs, NIOSH will host a public meeting to give an update of new protocol developments. The update will include discussions covering proposed drug surrogates, benefits, and challenges with developing a new universal test protocol, and to allow the public to comment. Special emphasis will be placed upon the following: • Proposed surrogates: Surrogates were identified based on vapor pressure and water solubility. Drug surrogates were chosen with vapor pressures up to 100 times that of the most volatile drug vapor pressure known to exist on the NIOSH hazardous drug list. The increased surrogate vapor pressure should offer a safety factor to the test protocol. Æ Is the 100 times the vapor pressure safety factor adequate? Æ Should other chemical properties besides vapor pressure and water solubility be considered? Æ Are there other surrogates NIOSH should consider for testing the performance of CSTDs? PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 63483 Æ Will any of the NIOSH’s list of proposed surrogates cause damage to the CSTD plastic and/or parts (i.e., needles, septum, etc.)? Æ Are there other aspects specific to air cleaning technologies that are not being challenged with the proposed surrogate testing protocol? Æ Are there other aspects specific to the barrier CSTD technologies that are not being adequately challenged with the proposed surrogate testing protocol? • Sampling Strategy: The new draft protocol relies upon analytical chemistry analysis of at least two simultaneously-collected sorbent tube air samples to detect drug surrogate escape from the CSTD. Æ Should less or more sampling tubes be used inside the environmental test chamber? Æ How should the sampling tubes be positioned inside the environmental test chamber? Æ Since contaminant levels will no longer be immediately known, background concentrations will not be realized until after test completion and sample analysis. What metrics should be applied to the background concentrations and how should they impact the reported concentrations observed during conduct of the protocol tasks? • Design of environmental test chamber: NIOSH proposes to keep the same environmental test chamber as that proposed for the original vapor containment test protocol, however airflow through the chamber will cease during the actual test procedures and air sampling. Æ Should NIOSH keep the current design of the environmental test chamber? • If not, what other designs should be considered and what validation requirements should be placed upon them? Æ Sampling for escaped surrogate will be performed by a sampling pump and air sampling tubes. • Are there concerns that the sample pump discharge air plus task-associated hand movements will be insufficient to provide adequate air mixing? • Compounding and Administration tasks: Æ NIOSH has updated Task 1 and Task 2 in Appendix A of the performance test protocol to incorporate the adoption of CSTD manufacturers’ Instructions for Use (IFU). • Should other manipulations be added or deleted from the current tasks listed in order to comply with a manufacturer’s IFU? Æ For purposes of challenging a CSTD’s containment performance, E:\FR\FM\15SEN1.SGM 15SEN1 sradovich on DSK3GMQ082PROD with NOTICES 63484 Federal Register / Vol. 81, No. 179 / Thursday, September 15, 2016 / Notices should the number of repetitions for each CSTD:Task pairing be less than or greater than 4? • What special considerations has NIOSH not considered in developing the new draft performance test protocol? III. Public Meeting: NIOSH will hold a public meeting to discuss a universal closed system drug-transfer device (CSTD) testing (draft) protocol entitled, A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs. The meeting will allow commenters the opportunity to address the new draft protocol, the proposed list of hazardous drug test surrogates, and to discuss NIOSH questions regarding the new protocol. The meeting is open to the public, limited only by the capacity (80 attendees) of the conference room. Confirm your attendance to this meeting by sending an email to DHirst@cdc.gov by October 21, 2016. An email confirming registration will be sent from NIOSH and will include details needed to participate. Registration is required for both inperson and LiveMeeting participation. An email confirming registration will be sent from NIOSH for both in-person participation and audio conferencing participation. Details required to participate via the audio conferencing will be provided by NIOSH in a separate email. This option will be available to participants on a first come, first served basis and is limited to the first 100 participants. Non-U.S. Citizens: Because of CDC Security Regulations, any non-U.S. citizen wishing to attend this meeting in-person must provide the following information to Deborah V. Hirst. Requests may be submitted by facsimile (513) 841–4506, or emailed to DHirst@ cdc.gov, no later than September 28, 2016. The information required includes: Name: Gender: Date of Birth: Place of Birth (city, province, state, country): Citizenship: Passport Number: Date of Passport Issue: Date of Passport Expiration: Type of Visa: U.S. Naturalization Number (if a naturalized citizen): U.S. Naturalization Date (if a naturalized citizen): Visitor’s Organization: Organization Address: Organization Telephone Number: VerDate Sep<11>2014 17:34 Sep 14, 2016 Jkt 238001 Visitor’s Position/Title within the Organization: This information will be transmitted to the CDC Security Office for approval. Visitors will be notified as soon as approval has been obtained. If access approval is not granted to a non-U.S. Citizen, the individual may participate by LiveMeeting and audio conference. Requests to provide oral comments at the public meeting should be submitted by telephone (513) 841–4141, facsimile (513) 841–4506, or emailed to DHirst@ cdc.gov with ‘‘Request to Speak’’ in the subject line. Requests can also be mailed to Deborah V. Hirst, 1090 Tusculum Ave., MS R–5, Cincinnati, OH 45226. All requests to speak should contain the name, address, telephone number, and relevant business affiliations of the speaker, and the approximate time requested for oral comments. Requests must be received by October 21, 2016. Oral comments from each speaker will be limited to 10 minutes. After reviewing the requests to make oral comments, NIOSH will notify the speaker when his/her oral comments are scheduled. If a participant is not in attendance when he/she is scheduled to speak, the remaining participants will be heard in order. After the last scheduled speaker is heard, participants who missed their assigned times may be allowed to speak, limited by time available. Attendees who wish to speak but did not submit a request for the opportunity to make oral comments may be given this opportunity after the scheduled speakers are heard, at the discretion of the presiding officer and limited by time available. Oral comments will be transcribed and included in the docket. John Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 2016–22132 Filed 9–14–16; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Supplement to National Technical Resource Center for the Newborn Hearing Screening and Intervention Program at the Utah State University Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice of Supplement to National Technical Resource Center for AGENCY: PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 the Newborn Hearing Screening and Intervention Program at the Utah State University—Grant Number U52MC04391. HRSA announces the award of a supplement in the amount of $300,000 for the National Technical Resource Center (NTRC) for the Newborn Hearing Screening and Intervention program cooperative agreement. Funding in future years is contingent upon satisfactory performance of the recipient, need, and availability of funds. The purpose of the NTRC is to address new research, approaches, and practice advances in the fields of family engagement, early language acquisition, and early literacy. The supplement will fund Utah State University, the cooperative agreement recipient, during the budget periods of the supplement 4/ 1/2016–3/31/2020, to respond to changes in research, policy, technology, and practice in the newborn hearing screening field in the areas of family engagement, early language acquisition, and early literacy. Funding in FY 2017, FY 2018, and FY 2019, is contingent upon appropriations, satisfactory performance of the recipient, need, and availability of funds. SUPPLEMENTARY INFORMATION: Intended Recipient of the Award: Utah State University. Amount of Non-Competitive Awards: $300,000. Period of Supplemental Funding: 4/1/ 2016–3/31/2020. CFDA Number: 93.251. Authority: Public Health Service Act, § 399M, as added by § 702 of the Children’s Health Act of 2000 (Pub. L. 106–310) and amended by § 2 of the Early Hearing Detection and Intervention Act of 2010 (Pub. L. 111– 337) (42 U.S.C. 280g–1) JUSTIFICATION: In 2015, following an objective review of its applications, HRSA awarded the NTRC for the Newborn Hearing Screening and Intervention program cooperative agreement to Utah State University, a state institution of higher education. Authorized by the Public Health Service Act, § 399M, as added by the Children’s Health Act of 2000, § 702 (Pub. L. 106–310) and further amended by § 2 of the Early Hearing Detection and Intervention Act of 2010 (Pub. L. 111–337) (42 U.S.C. 280g–1), the purpose of the Universal Newborn Hearing Screening (UNHS) program is to utilize specifically targeted and measurable interventions to increase the number of infants who are followed up for rescreening, referral, and intervention after not passing a SUMMARY: E:\FR\FM\15SEN1.SGM 15SEN1

Agencies

[Federal Register Volume 81, Number 179 (Thursday, September 15, 2016)]
[Notices]
[Pages 63482-63484]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22132]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[CDC-2016-0090, Docket Number NIOSH 288-A]


A Performance Test Protocol for Closed System Transfer Devices 
Used During Pharmacy Compounding and Administration of Hazardous Drugs

AGENCY: National Institute for Occupational Safety and Health (NIOSH) 
of the Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice of public meeting and request for public comment on a 
draft testing protocol.

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

SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH) of the Centers for Disease Control and Prevention (CDC) 
announces a public meeting concerning a universal closed system drug-
transfer device (CSTD) testing protocol entitled, A Performance Test 
Protocol for Closed System Transfer Devices Used During Pharmacy 
Compounding and Administration of Hazardous Drugs, http://www.cdc.gov/niosh/topics/hazdrug/default.html/.
    This is an opportunity for public comment on the protocol, the 
proposed list of surrogates, and to respond to NIOSH questions 
regarding the protocol.
    To view the protocol and related materials, visit 
www.regulations.gov and enter CDC-2016-0090 in the search field and 
click ``Search.''

[[Page 63483]]

Table of Contents

I. Background
II. Protocol
III. Public Meeting

DATES: The public meeting will be held on November 7, 2016, 9:00 a.m.-
3:00 p.m. Eastern Time, or until after the last public commenter has 
spoken, whichever occurs first. Electronic or written comments must be 
received by December 7, 2016.

ADDRESSES: The public meeting will be held at the Alice Hamilton 
Laboratories, Conference Room C, 5555 Ridge Avenue, Cincinnati, OH 
45213. Virtual attendance using LiveMeeting and audio conference will 
be available.
    You may submit written comments, identified by CDC-2016-0090 and 
Docket Number NIOSH 288-A, by either of the following two methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     Mail: National Institute for Occupational Safety and 
Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, Cincinnati, 
Ohio 45226-1998.
    Instructions: All information received in response to this notice 
must include the agency name and docket number [CDC-2016-0090; NIOSH 
288-A]. All relevant comments received will be posted without change to 
http://www.regulations.gov, including any personal information 
provided. All information received in response to this notice will also 
be available for public examination and copying at the NIOSH Docket 
Office, 1150 Tusculum Avenue, Room 155, Cincinnati, OH 45226-1998.

FOR FURTHER INFORMATION CONTACT: Deborah V. Hirst, NIOSH, Division of 
Applied Research and Technology, Alice Hamilton Laboratories, 1090 
Tusculum Ave., MS R-5, Cincinnati, OH 45226. (513) 841-4141 (not a toll 
free number) or email DHirst@cdc.gov.

SUPPLEMENTARY INFORMATION:
    I. Background: Closed system drug-transfer devices (CSTDs) are 
generally available in two design types: (1) One that uses a physical 
barrier to block the unintended release of drug into the surrounding 
environment or the intake of environmental contaminants into the 
sterile drug pathway and (2) one that uses air cleaning or filtration 
technologies to prevent the unintended release of drug into the 
surrounding environment or the intake of environmental contaminants 
into the sterile drug pathway. On September 8, 2015, NIOSH released the 
draft test protocol, A Vapor Containment Performance Protocol for 
Closed System Transfer Devices Used During Pharmacy Compounding and 
Administration of Hazardous Drugs, for public review. The draft 
protocol was developed by NIOSH to evaluate how containment effective 
the physical barrier-type CSTDs were as an indicator of how protective 
they would be at preventing hazardous drug escape from the closed 
system. After significant public comment and several inquiries, on 
January 19, 2016, NIOSH published a Request for Information for the 
development of a test protocol to evaluate the performance of CSTDs 
that adopt air-cleaning or filtration technologies. Since the Federal 
Register docket for both the draft protocol and the request for 
information closed on March 8, 2016, NIOSH has done the following:
    a. Generated a list of surrogates to test both types of CSTDs.
    b. Met individually with CSTD manufacturers who requested informal 
meetings to discuss the current draft protocol and/or items NIOSH 
should consider in developing a new performance test protocol for air-
cleaning CSTDs. This was in answer to NIOSH's Request for Information 
question #12, Are you interested in being a collaborative partner with 
NIOSH on the development of an air cleaning or filtration technologies 
CSTD test protocol?
    c. Drafted a new universal performance test protocol applicable to 
both barrier and air-cleaning types of CSTDs.
    II. Protocol: The proposed protocol will apply to both barrier and 
air-cleaning types of CSTDs, NIOSH will host a public meeting to give 
an update of new protocol developments. The update will include 
discussions covering proposed drug surrogates, benefits, and challenges 
with developing a new universal test protocol, and to allow the public 
to comment. Special emphasis will be placed upon the following:
     Proposed surrogates: Surrogates were identified based on 
vapor pressure and water solubility. Drug surrogates were chosen with 
vapor pressures up to 100 times that of the most volatile drug vapor 
pressure known to exist on the NIOSH hazardous drug list. The increased 
surrogate vapor pressure should offer a safety factor to the test 
protocol.
    [cir] Is the 100 times the vapor pressure safety factor adequate?
    [cir] Should other chemical properties besides vapor pressure and 
water solubility be considered?
    [cir] Are there other surrogates NIOSH should consider for testing 
the performance of CSTDs?
    [cir] Will any of the NIOSH's list of proposed surrogates cause 
damage to the CSTD plastic and/or parts (i.e., needles, septum, etc.)?
    [cir] Are there other aspects specific to air cleaning technologies 
that are not being challenged with the proposed surrogate testing 
protocol?
    [cir] Are there other aspects specific to the barrier CSTD 
technologies that are not being adequately challenged with the proposed 
surrogate testing protocol?
     Sampling Strategy: The new draft protocol relies upon 
analytical chemistry analysis of at least two simultaneously-collected 
sorbent tube air samples to detect drug surrogate escape from the CSTD.
    [cir] Should less or more sampling tubes be used inside the 
environmental test chamber?
    [cir] How should the sampling tubes be positioned inside the 
environmental test chamber?
    [cir] Since contaminant levels will no longer be immediately known, 
background concentrations will not be realized until after test 
completion and sample analysis. What metrics should be applied to the 
background concentrations and how should they impact the reported 
concentrations observed during conduct of the protocol tasks?
     Design of environmental test chamber: NIOSH proposes to 
keep the same environmental test chamber as that proposed for the 
original vapor containment test protocol, however airflow through the 
chamber will cease during the actual test procedures and air sampling.
    [cir] Should NIOSH keep the current design of the environmental 
test chamber?
     If not, what other designs should be considered and what 
validation requirements should be placed upon them?
    [cir] Sampling for escaped surrogate will be performed by a 
sampling pump and air sampling tubes.
     Are there concerns that the sample pump discharge air plus 
task-associated hand movements will be insufficient to provide adequate 
air mixing?
     Compounding and Administration tasks:
    [cir] NIOSH has updated Task 1 and Task 2 in Appendix A of the 
performance test protocol to incorporate the adoption of CSTD 
manufacturers' Instructions for Use (IFU).
     Should other manipulations be added or deleted from the 
current tasks listed in order to comply with a manufacturer's IFU?
    [cir] For purposes of challenging a CSTD's containment performance,

[[Page 63484]]

should the number of repetitions for each CSTD:Task pairing be less 
than or greater than 4?
     What special considerations has NIOSH not considered in 
developing the new draft performance test protocol?
    III. Public Meeting: NIOSH will hold a public meeting to discuss a 
universal closed system drug-transfer device (CSTD) testing (draft) 
protocol entitled, A Performance Test Protocol for Closed System 
Transfer Devices Used During Pharmacy Compounding and Administration of 
Hazardous Drugs. The meeting will allow commenters the opportunity to 
address the new draft protocol, the proposed list of hazardous drug 
test surrogates, and to discuss NIOSH questions regarding the new 
protocol.
    The meeting is open to the public, limited only by the capacity (80 
attendees) of the conference room. Confirm your attendance to this 
meeting by sending an email to DHirst@cdc.gov by October 21, 2016. An 
email confirming registration will be sent from NIOSH and will include 
details needed to participate.
    Registration is required for both in-person and LiveMeeting 
participation. An email confirming registration will be sent from NIOSH 
for both in-person participation and audio conferencing participation.
    Details required to participate via the audio conferencing will be 
provided by NIOSH in a separate email. This option will be available to 
participants on a first come, first served basis and is limited to the 
first 100 participants.
    Non-U.S. Citizens: Because of CDC Security Regulations, any non-
U.S. citizen wishing to attend this meeting in-person must provide the 
following information to Deborah V. Hirst. Requests may be submitted by 
facsimile (513) 841-4506, or emailed to DHirst@cdc.gov, no later than 
September 28, 2016. The information required includes:

Name:
Gender:
Date of Birth:
Place of Birth (city, province, state, country):
Citizenship:
Passport Number:
Date of Passport Issue:
Date of Passport Expiration:
Type of Visa:
U.S. Naturalization Number (if a naturalized citizen):
U.S. Naturalization Date (if a naturalized citizen):
Visitor's Organization:
Organization Address:
Organization Telephone Number:
Visitor's Position/Title within the Organization:

    This information will be transmitted to the CDC Security Office for 
approval. Visitors will be notified as soon as approval has been 
obtained. If access approval is not granted to a non-U.S. Citizen, the 
individual may participate by LiveMeeting and audio conference.
    Requests to provide oral comments at the public meeting should be 
submitted by telephone (513) 841-4141, facsimile (513) 841-4506, or 
emailed to DHirst@cdc.gov with ``Request to Speak'' in the subject 
line. Requests can also be mailed to Deborah V. Hirst, 1090 Tusculum 
Ave., MS R-5, Cincinnati, OH 45226. All requests to speak should 
contain the name, address, telephone number, and relevant business 
affiliations of the speaker, and the approximate time requested for 
oral comments. Requests must be received by October 21, 2016.
    Oral comments from each speaker will be limited to 10 minutes. 
After reviewing the requests to make oral comments, NIOSH will notify 
the speaker when his/her oral comments are scheduled. If a participant 
is not in attendance when he/she is scheduled to speak, the remaining 
participants will be heard in order. After the last scheduled speaker 
is heard, participants who missed their assigned times may be allowed 
to speak, limited by time available.
    Attendees who wish to speak but did not submit a request for the 
opportunity to make oral comments may be given this opportunity after 
the scheduled speakers are heard, at the discretion of the presiding 
officer and limited by time available.
    Oral comments will be transcribed and included in the docket.

John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2016-22132 Filed 9-14-16; 8:45 am]
 BILLING CODE 4163-19-P