[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60906-60908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25646]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-16-15BHH; Docket No. CDC-2016-0087]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the Personal 
Protective Equipment Information (PPE-Info) Database which is a 
compendium of personal protective equipment (PPE) Federal regulations 
and consensus standards.

DATES: Written comments must be received on December 7, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0087 by any of the following methods:
    Federal eRulemaking Portal: Regulation.gov. Follow the instructions 
for submitting comments.
    Mail: Leroy A. Richardson, Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note: All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

[[Page 60907]]

Proposed Project

    PPE-Info Database--New--National Institute for Occupational Safety 
and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The mission of the National Institute for Occupational Safety and 
Health (NIOSH) is to promote safety and health at work for all people 
through research and prevention. Under Public Law 91-173 as amended by 
Public Law 95-164 (Federal Mine Safety and Health Act of 1977), NIOSH 
is proposing a three-year study to conduct research to advance the 
health and safety of workers.
    National Personal Protective Technology Laboratory (NPPTL) 
developed the NIOSH PPE-Info Database in response to recommendations 
from the Institute of Medicine (IOM) in its report, Certifying Personal 
Protective Technologies (PPT): Improving Worker Safety. The report 
recommended that NPPTL ``expand its efforts to become a national 
clearinghouse for information on all types of PPT.''
    In its current application, the database provides standards 
developers, manufacturers, purchasers, and end users of PPE with a 
comprehensive tool which allows general or advanced criteria searches 
of relevant standards, target occupational groups, basic conformity 
assessment specifications, accredited lab information, and standard 
connections.
    The CDC is currently updating its PPE selection guidance related to 
the Ebola response. This guidance, Guidance on Personal Protective 
Equipment To Be Used by Healthcare Workers During Management of 
Patients with Ebola Virus Disease in U.S. Hospitals, Including 
Procedures for Putting On (Donning) and Removing (Doffing) (hereafter 
referred to as the ``CDC Ebola Response PPE Guidance'') will provide 
recommendations, in the form of protection standards, for PPE selection 
and use for the Ebola response.
    The NIOSH PPE-Info Database is being expanded as a tool to connect 
the protection standards that already exist in the database, with 
relevant PPE information as identified through the updated CDC Ebola 
Response PPE Guidance. This new aspect of the NIOSH PPE-Info Database 
allows end users (e.g., healthcare workers) to find products (e.g., 
gowns and coveralls) that are compliant (as verified by manufacturer) 
with the protection standards outlined by the CDC Ebola Response PPE 
Guidance. The initial information in the NIOSH PPE-Info Database will 
only offer guidance on gowns and coveralls, but is intended to expand 
to all PPE types associated with the official CDC Ebola Response PPE 
Guidance in the future. Since there is no single source of this 
information, NOISH is requesting that Manufactures provide it directly 
for input into the Ebola PPE selection guidance portion of the 
database.
    NIOSH is requesting that a Memorandum of Understanding (MOU) be 
developed with Ebola response PPE manufacturers to facilitate 
cooperation and collaboration on the provision of product information. 
The primary focus of the collaboration will be the exchange of 
manufacturer product information to be aggregated and displayed in the 
NIOSH PPE-Info Database.
    The nature and use of this information exchange includes the (1) 
provision of product information regarding compliance (as verified by 
manufacturers) with designated protection standards related to CDC 
guidance for personal protective equipment (PPE) used by healthcare 
workers during management of patients with confirmed or suspected Ebola 
Virus Disease (``Ebola'') and (2) the verification, by manufacturers, 
of product information displayed in the NIOSH PPE-Info Database.
    Once the MOU is signed, the manufacturer will be sent a product 
information sheet. Using he product information sheet, NIOSH collects 
manufacturer-specific product information such as; product category 
(e.g., gown or coverall), standards that the product claim complies 
with, product model number, product name, link to product specification 
sheet from manufacturer, and designation of whether third-party testing 
was performed. Once this information is completed, the product 
information sheet is electronically signed and returned by email to 
NIOSH. The NIOSH project officer will then upload the information into 
a PPE-Info sub database, which acts as an interim point for review. The 
manufacturer is then sent a link to the sub database to review their 
products. The manufacturer has one week to make objections. If no 
objections are made, the information in the sub-database gets published 
to the live NIOSH PPE-Info database.
    Quarterly, manufacturer products will be pulled from the database 
and sent through a pre generated product information sheet to the 
manufacturer POC. Manufacturers are required through the MOU to 
complete and return the PPE Information Sheet within two weeks of 
receipt along with the electronic verification form.
    NIOSH will be soliciting information from manufacturers and 
manufacturer POCs. For products that comply with gown and coverall 
standards, we estimate that seven manufacturers will need to supply 
product information. The amount of time for manufacturers to complete 
the initial product information sheets and make quarterly updated will 
be no more than 3 hours for the initial product information and one 
hour for the quarterly updates. The total estimated burden hours are 
42. There are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                                          Average
                                                        Number of         Number        burden per       Total
       Type of respondent             Form name        respondents    responses per    response  (in    burden
                                                                        respondent        hours)         hours
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Manufacturer...................  Initial Product                  7                1               3
                                  Info Sheet.
Manufacturer POC...............  Quarterly product                7                3               1          21
                                  Info Sheet.
                                                    ------------------------------------------------------------
    Total......................  ..................  ..............  ...............  ..............          42
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[[Page 60908]]

Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-25646 Filed 10-7-15; 8:45 am]
 BILLING CODE 4163-18-P