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[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Proposed Rules]
[Pages 33188-33189]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14186]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 84

[Docket Number NIOSH-109]
RIN 0920-AA04

Quality Assurance Requirements for Respirators; Notice of 
Withdrawal

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

ACTION: Notice of proposed rulemaking; withdrawal.

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SUMMARY: The Department of Health and Human Services (HHS) is 
withdrawing its proposed rule to update the quality assurance and 
control requirements for the manufacture of respirators approved under 
42 CFR Part 84 by the National Institute for Occupational Safety and 
Health (NIOSH), Centers for Disease Control and Prevention and the Mine 
Safety and Health Administration (MSHA). NIOSH has reviewed the 
comments it received to the proposed rule and determined that 
additional analysis is needed to assess the economic impact of its 
proposed rule. NIOSH plans to seek further information and to consider 
possible alternative approaches.

DATES: The proposed rule published on December 10, 2008 (73 FR 75045) 
will be withdrawn as of June 8, 2011.

FOR FURTHER INFORMATION CONTACT: William Newcomb, NIOSH National 
Personal Protective Technology Laboratory (NPPTL), P.O. Box 18070, 626 
Cochrans Mill Road, Pittsburgh, PA 15236, telephone (412) 386-4034 
(this is

[[Page 33189]]

not a toll-free number), e-mail byf6@cdc.gov.

SUPPLEMENTARY INFORMATION: On December 10, 2008, HHS proposed a rule 
intended to update the quality assurance and control requirements for 
the manufacture of respirators approved under 42 CFR part 84 by NIOSH 
and MSHA (73 FR 75045). The comment period for the proposed rule 
originally closed on February 9, 2009 but was reopened and extended 
until April 10, 2009 (74 FR 9381), and subsequently extended to October 
9, 2009 (74 FR 23815). NIOSH also held public meetings on its proposed 
rule on March 23, 2009 in Adelphi, Maryland and on March 30, 2009 in 
Los Angeles, California.
    NIOSH has reviewed the transcripts of the public meetings and the 
written comments received. While the commenters were generally 
supportive of the need to update the quality assurance and control 
requirements, they raised questions about several areas of the proposed 
rule pertaining to its economic impact. NIOSH has decided that this 
issue requires additional consideration and further economic analysis 
before considering or proceeding with alternatives to the proposed 
rule. This action is consistent with Executive Order 13563 which 
requires Federal agencies to conduct a retrospective review of 
regulations to determine which rules may ``be modified, streamlined, 
expanded, or repealed so as to make the agency's regulatory program 
more effective or less burdensome in achieving the regulatory 
objectives.''
    Although not required to do so by the Administrative Procedure Act 
or by the regulations of the Office of Federal Register, HHS believes 
the public interest is best served by withdrawing the proposed rule 
identified in this document. The withdrawal of the proposed rule 
identified in this document does not preclude HHS from reinitiating 
rulemaking in the future regarding quality assurance and control 
requirements for the manufacture of respirators approved under 42 CFR 
part 84. Should HHS decide to undertake such rulemaking sometime in the 
future, it will re-propose the action and provide new opportunities for 
comment.
    For the reasons stated herein, the notice of proposed rulemaking 
published on December 10, 2008 is hereby withdrawn.

    Dated: May 31, 2011.
Kathleen Sebelius
Secretary, Department of Health and Human Services.
[FR Doc. 2011-14186 Filed 6-7-11; 8:45 am]
BILLING CODE 4163-18-P
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