2011-14186. 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.

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The proposed rule published on December 10, 2008 (73 FR 75045) will be withdrawn as of June 8, 2011.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 [phone] (this is not a toll-free number), e-mail [e-mail].

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.