Strategy To Address Recommendations Issued by the Institute of Medicine in November 2010 Report; Comment Request, 28791 [2011-12167]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 96 (Wednesday, May 18, 2011)]
[Notices]
[Page 28791]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12167]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket Number NIOSH-237]


Strategy To Address Recommendations Issued by the Institute of 
Medicine in November 2010 Report; Comment Request

AGENCY: The 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 comment period.

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SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH), National Personal Protective Technology Laboratory (NPPTL), 
requests input on the NIOSH, NPPTL strategy to address the 
recommendations issued by the Institute of Medicine (IOM) in the 
November 2010 report Certifying Personal Protective Technologies: 
Improving Worker Safety. The report focuses on the need for a 
consistent and risk-based approach to Personal Protective Technology 
(PPT) conformity assessment.

PUBLIC COMMENT PERIOD: Written or electronic comments must be received 
on or before July 1, 2011.

ADDRESSES: You may submit comments, identified by docket number NIOSH-
237, by any of the following methods:
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226
     Facsimile: (513) 533-8285
     E-mail: nioshdocket@cdc.gov
    All information received in response to this notice will be 
available for public examination and copying at the NIOSH Docket 
Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226. All comments 
received will be available on the NIOSH Docket Web page at https://www.cdc.gov/niosh/docket, and in writing by request. NIOSH includes all 
comments received without change in the docket and the electronic 
docket, including any personal information provided.

FOR FURTHER INFORMATION CONTACT: John Sporrer, NIOSH, NPPTL, Post 
Office Box 18070, Building 20, Pittsburgh, PA 15236; E-mail 
ppeconcerns@cdc.gov, telephone (412) 386-6435.

SUPPLEMENTARY INFORMATION: In the November 2010 report the Institute of 
Medicine (IOM) made three recommendations for advancing conformity 
assessment for Personal Protective Technologies (PPT) in the nation. 
These recommendations are:
    (1) Develop and Implement Risk-Based Conformity Assessment 
Processes for Non-Respirator PPT; (2) Enhance Research, Standards 
Development, and Communication; and (3) Establish a PPT and 
Occupational Safety and Health Surveillance System.
    The report may be accessed, for free, at: https://www.nap.edu/catalog.php?record_id=12962.

Conformity Assessment Components

    NIOSH, NPPTL envisions that PPT conformity assessment can involve 
the following components: standards, testing, inspection, 
certification, registration, accreditation, supplier's declaration of 
conformity (SDoC), communication, post-market testing and evaluation, 
and health surveillance. NIOSH, NPPTL is already responsible for 
certifying respirators for use in the United States. The management 
responsibilities of PPT Program conformity assessment undertaken by 
NIOSH, NPPTL include developing the strategy to implement the IOM 
recommendations.

Near Term Strategy

    NIOSH, NPPTL intends to implement a multi-year strategy to address 
Recommendation 1 of the IOM report to develop and implement risk-based 
conformity assessment processes for non-respirator PPT.
    The impacts of non-compliance (consequences of failure to provide 
the expected protection) are best described in terms of their potential 
risk to the user and the independence and rigor of conformity 
assessment. This relationship is described in Gordon Gillerman's Making 
the Confidence Connection published in ASTM Standardization News 
(2004), which can be viewed at https://www.astm.org/SNEWS/DECEMBER_2004/gillerman_dec04.html.

Timeline To Address Recommendation 1

    The timeline to address Recommendation 1 includes, but is not 
limited to the following activities conducted over a two year time 
period:
    1. defining the standards to be included in the process;
    2. identifying the PPE on the market which complies with current 
standards;
    3. finalizing the conformity assessment terminology to be used in 
the effort;
    4. defining low, medium, and high levels of risk;
    5. assessing available sources (e.g. surveillance data) to document 
the risks of the PPE not working properly and the risks of 
noncompliance;
    6. defining the level of conformity assessment, including 
configuration management, required for each level of risk; and
    7. defining the types of PPE to be included in the framework to 
include those required by regulation, those desired by the user, and 
those that respond to specific health and safety needs in the 
marketplace.
    NIOSH, NPPTL will develop a draft risk-based strategy and solicit 
public comment on the strategy. NIOSH, NPPTL will conduct face-to-face 
and virtual public meetings to discuss the PPT conformity assessment 
strategy during the strategy development process. The proposed strategy 
will be published and is expected to serve as a reference for standards 
development organizations.
    Stakeholder input to the NIOSH, NPPTL strategy to address the 
recommendations provided in the IOM report may be submitted to NIOSH 
Docket 237 until July 1, 2011.

    Dated: May 11, 2011.
John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2011-12167 Filed 5-17-11; 8:45 am]
BILLING CODE 4163-18-P