80 FR 53802 - A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs; Request for Comment
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 173 (September 8, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 173 (September 8, 2015)
| Page Range | 53802-53803 | |
| FR Document | 2015-22525 |
[Federal Register Volume 80, Number 173 (Tuesday, September 8, 2015)] [Notices] [Pages 53802-53803] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-22525] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [CDC-2015-0075, Docket Number NIOSH-288] A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs; Request for Comment 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 draft document available for public comment. ----------------------------------------------------------------------- SUMMARY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document for public comment entitled A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs. The document and instructions for submitting comments can be found at www.regulations.gov. This guidance document does not have the force and effect of law. Table of ContentsDATES: ADDRESSES: FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DATES: Electronic or written comments must be received by November 9, 2015. ADDRESSES: You may submit comments, identified by CDC-2015-0075 and Docket Number NIOSH-288, by either of the two following methods: Federal eRulemaking Portal: www.regulations.gov Follow the instructions for submitting comments. Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 1090 Tusculum Avenue, MS-C34, Cincinnati, Ohio 45226. Instructions: All information received in response to this notice must include the agency name and the docket number (CDC-2015-0075; NIOSH-288). All relevant comments received will be posted without change to www.regulations.gov, including any personal information provided. All electronic comments should be formatted as Microsoft Word. Please make reference to CDC-2015-0075 and Docket Number NIOSH- 288. 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 Avenue, MS R-5, Cincinnati, Ohio 45226, (513) 841-4141 (not a toll free number), Email: [email protected]. SUPPLEMENTARY INFORMATION: The purpose of the protocol is to test a closed system transfer device's (CSTD) capability to perform as a closed system. During an evaluation of the protocol, [[Page 53803]] registered pharmacists, familiar with the use of CSTDs, tested the protocol's prescribed compounding and administration tasks using five commercially available CSTDs. They also performed the assigned tasks using a negative control condition without a CSTD. Prescribed tasks were performed in a NIOSH-developed environmental test chamber with 70% isopropyl alcohol (IPA) as the challenge agent. A highly specific gas analyzer, with measurement capabilities specific to IPA and with a low limit of detection (LOD), was used to detect vapor concentrations of escaped IPA during the tasks. The protocol is not intended for CSTDs designed to operate using air-cleaning technologies. This protocol has multiple applications and can be used by manufacturers to evaluate prototype CSTDs, by consumers to compare CSTD products, or by jurisdictions wishing to adopt the protocol for a CSTD performance certification procedure. A panel consisting of peer reviewers and stakeholders was asked to review and comment on the draft guidance document and protocol. NIOSH reviewed the recommendations of the peer reviewers and stakeholders then made the final determination regarding document content as well as the decision not to propose a specific pass/fail performance threshold. The protocol is being published for comment in CDC-2015-0075 and Docket Number NIOSH-288 and can be found at www.regulations.gov. Dated: September 1, 2015. John Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 2015-22525 Filed 9-4-15; 8:45 am] BILLING CODE 4163-19-P
![53802 Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices
information is aircraft traveling within almost always submitted electronically the facilitation of reporting using
the United States. via radio, so the current Master of electronic means, i.e., Air Traffic
This revision makes several Vessel or Conveyance Illness Report has Control and the Domestic Events
modification to this information been rendered obsolete. In addition, Network for domestic flights.
collection. They are as follows: CDC has issued guidance stating that The resulting change in burden is a
• In current practice, CDC does not reports to CDC, instead of local health reduction of 3,678 hours.
process applications for travel permits. authorities, regarding domestic reports For reports of death or communicable
The issuance of travel restrictions is a of communicable disease or death on disease made by master of a vessel or
collaborative process between public board conveyances meet the person in charge of a conveyance
health partners, e.g., state health requirements of the regulation; engaged in interstate traffic, the
departments, the Department of therefore, information collections requested burden is approximately 23
Homeland Security, and CDC. There is related to copies sent to state health hours. This total is estimated from 200
no standardized collection of departments are no longer necessary. respondents submitting domestic
information involved. This change This primary concerns interstate flights. reports of death or communicable
results in the removal of the Ill Person • CDC is also requesting an disease a year, with an average burden
Travel Permit from the list of adjustment to the burden associated of 7 minutes per report. This totals 23
information collections as well as the with reports of communicable disease or hours. There is no burden to
removal of the associated burden. death from domestic conveyances. CDC respondents other than the time
• Reports of communicable disease or is reducing the burden from 15 minutes required to make the report of illness or
death from domestic conveyances are per report to 7 minutes. This is due to death.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondent Form name responses per
respondents response (in hours)
respondent (in hours)
Master of a vessel or person in 42 CFR 70.4 Report by the master 200 1 7/60 23
charge of a conveyance. of a vessel or person in charge of
conveyance of the incidence of a
communicable disease occurring
while in interstate travel.
Total ........................................... ........................................................... ........................ ........................ ........................ 23
Leroy A. Richardson, SUMMARY: The National Institute for Avenue, MS–C34, Cincinnati, Ohio
Chief, Information Collection Review Office, Occupational Safety and Health 45226.
Office of Scientific Integrity, Office of the (NIOSH) of the Centers for Disease Instructions: All information received
Associate Director for Science, Office of the Control and Prevention (CDC) in response to this notice must include
Director, Centers for Disease Control and announces the availability of the the agency name and the docket number
Prevention. following draft document for public (CDC–2015–0075; NIOSH–288). All
[FR Doc. 2015–22549 Filed 9–4–15; 8:45 am] comment entitled A Vapor Containment relevant comments received will be
BILLING CODE 4163–18–P Performance Protocol for Closed System posted without change to
Transfer Devices Used During Pharmacy www.regulations.gov, including any
Compounding and Administration of personal information provided. All
DEPARTMENT OF HEALTH AND Hazardous Drugs. The document and electronic comments should be
HUMAN SERVICES instructions for submitting comments formatted as Microsoft Word. Please
Centers for Disease Control and can be found at www.regulations.gov. make reference to CDC–2015–0075 and
This guidance document does not Docket Number NIOSH–288. All
Prevention
have the force and effect of law. information received in response to this
[CDC–2015–0075, Docket Number NIOSH– notice will also be available for public
288] Table of Contents
examination and copying at the NIOSH
• DATES: Docket Office, 1150 Tusculum Avenue,
A Vapor Containment Performance • ADDRESSES: Room 155, Cincinnati, OH 45226–1998.
Protocol for Closed System Transfer • FOR FURTHER INFORMATION
Devices Used During Pharmacy CONTACT: FOR FURTHER INFORMATION CONTACT:
Compounding and Administration of • SUPPLEMENTARY INFORMATION: Deborah V. Hirst, NIOSH, Division of
Hazardous Drugs; Request for Applied Research and Technology,
DATES: Electronic or written comments
Comment Alice Hamilton Laboratories, 1090
must be received by November 9, 2015.
Tusculum Avenue, MS R–5, Cincinnati,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
AGENCY: National Institute for ADDRESSES: You may submit comments,
Ohio 45226, (513) 841–4141 (not a toll
Occupational Safety and Health identified by CDC–2015–0075 and free number), Email: hazardousdrugs@
(NIOSH) of the Centers for Disease Docket Number NIOSH–288, by either cdc.gov.
Control and Prevention (CDC), of the two following methods:
Department of Health and Human • Federal eRulemaking Portal: SUPPLEMENTARY INFORMATION: The
Services (HHS). www.regulations.gov Follow the purpose of the protocol is to test a
instructions for submitting comments. closed system transfer device’s (CSTD)
ACTION: Notice of draft document
• Mail: NIOSH Docket Office, Robert capability to perform as a closed system.
available for public comment.
A. Taft Laboratories, 1090 Tusculum During an evaluation of the protocol,
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![Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices 53803
registered pharmacists, familiar with the concerning each proposed collection of to publish a 30-day notice in the
use of CSTDs, tested the protocol’s information, including each proposed Federal Register concerning each
prescribed compounding and extension or reinstatement of an existing proposed collection of information,
administration tasks using five collection of information, and to allow including each proposed extension or
commercially available CSTDs. They a second opportunity for public reinstatement of an existing collection
also performed the assigned tasks using comment on the notice. Interested of information, before submitting the
a negative control condition without a persons are invited to send comments collection to OMB for approval. To
CSTD. Prescribed tasks were performed regarding the burden estimate or any comply with this requirement, CMS is
in a NIOSH-developed environmental other aspect of this collection of publishing this notice that summarizes
test chamber with 70% isopropyl information, including any of the
the following proposed collection(s) of
alcohol (IPA) as the challenge agent. A following subjects: (1) The necessity and
information for public comment:
highly specific gas analyzer, with utility of the proposed information
measurement capabilities specific to collection for the proper performance of 1. Type of Information Collection
IPA and with a low limit of detection the agency’s functions; (2) the accuracy Request: Reinstatement without change
(LOD), was used to detect vapor of the estimated burden; (3) ways to of a previously approved collection;
concentrations of escaped IPA during enhance the quality, utility, and clarity Title of Information Collection: Site
the tasks. The protocol is not intended of the information to be collected; and Investigation for Independent
for CSTDs designed to operate using air- (4) the use of automated collection Diagnostic Testing Facilities (IDTFs);
cleaning technologies. This protocol has techniques or other forms of information Use: We enroll Independent Diagnostic
multiple applications and can be used technology to minimize the information Testing Facilities (IDTFs) into the
by manufacturers to evaluate prototype collection burden. Medicare program via a uniform
CSTDs, by consumers to compare CSTD DATES: Comments on the collection(s) of application, the CMS 855B.
products, or by jurisdictions wishing to information must be received by the Implementation of enhanced procedures
adopt the protocol for a CSTD OMB desk officer by October 8, 2015. for verifying the enrollment information
performance certification procedure. ADDRESSES: When commenting on the has improved the enrollment process as
A panel consisting of peer reviewers proposed information collections,
and stakeholders was asked to review well as identified and prevented
please reference the document identifier fraudulent IDTFs from entering the
and comment on the draft guidance or OMB control number. To be assured
document and protocol. NIOSH Medicare program. As part of this
consideration, comments and process, verification of compliance with
reviewed the recommendations of the recommendations must be received by
peer reviewers and stakeholders then IDTF performance standards is
the OMB desk officer via one of the necessary. The primary function of the
made the final determination regarding
following transmissions: OMB, Office of site investigation form for IDTFs is to
document content as well as the
Information and Regulatory Affairs,
decision not to propose a specific pass/ provide a standardized, uniform tool to
Attention: CMS Desk Officer, Fax
fail performance threshold. The protocol gather information from an IDTF that
Number: (202) 395–5806 OR Email:
is being published for comment in CDC– tells us whether it meets certain
OIRA_ submission@omb.eop.gov.
2015–0075 and Docket Number NIOSH– To obtain copies of a supporting standards to be a IDTF (as found in 42
288 and can be found at statement and any related forms for the CFR 410.33(g)) and where it practices or
www.regulations.gov. proposed collection(s) summarized in renders its services. The site
Dated: September 1, 2015. this notice, you may make your request investigation form has been used in the
John Howard, using one of following: past to aid in verifying compliance with
Director, National Institute for Occupational 1. Access CMS’ Web site address at the required performance standards
Safety and Health, Centers for Disease Control http://www.cms.hhs.gov/ found in 42 CFR 410.33(g). No revisions
and Prevention. PaperworkReductionActof1995. have been made to this form since the
[FR Doc. 2015–22525 Filed 9–4–15; 8:45 am] 2. Email your request, including your last submission for OMB approval. Form
BILLING CODE 4163–19–P address, phone number, OMB number, Number: CMS–10221 (OMB Control
and CMS document identifier, to Number: 0938–1029); Frequency:
Paperwork@cms.hhs.gov. Occasionally; Affected Public: Private
DEPARTMENT OF HEALTH AND 3. Call the Reports Clearance Office at Sector (Business or other for-profits and
HUMAN SERVICES (410) 786–1326. Not-for-profit institutions); Number of
FOR FURTHER INFORMATION CONTACT: Respondents: 900; Total Annual
Centers for Medicare & Medicaid Reports Clearance Office at (410) 786–
Services Responses: 900; Total Annual Hours:
1326. 1,800. (For policy questions regarding
[Document Identifier: CMS–10221] SUPPLEMENTARY INFORMATION: Under the this collection contact Kim McPhillips
Paperwork Reduction Act of 1995 (PRA) at 410–786–5374).
Agency Information Collection (44 U.S.C. 3501–3520), federal agencies
Activities: Submission for OMB Dated: September 2, 2015.
must obtain approval from the Office of
Review; Comment Request Management and Budget (OMB) for each William N. Parham, III,
collection of information they conduct Director, Paperwork Reduction Staff, Office
ACTION: Notice.
or sponsor. The term ‘‘collection of of Strategic Operations and Regulatory
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY: The Centers for Medicare & information’’ is defined in 44 U.S.C. Affairs.
Medicaid Services (CMS) is announcing 3502(3) and 5 CFR 1320.3(c) and [FR Doc. 2015–22530 Filed 9–4–15; 8:45 am]
an opportunity for the public to includes agency requests or BILLING CODE 4120–01–P
comment on CMS’ intention to collect requirements that members of the public
information from the public. Under the submit reports, keep records, or provide
Paperwork Reduction Act of 1995 information to a third party. Section
(PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C.
publish notice in the Federal Register 3506(c)(2)(A)) requires federal agencies
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Document Created: 2018-02-26 10:13:37
Document Modified: 2018-02-26 10:13:37
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of draft document available for public comment. | |
| Dates | Electronic or written comments must be received by November 9, 2015. | |
| Contact | <bullet> SUPPLEMENTARY INFORMATION: | |
| FR Citation | 80 FR 53802 |
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