[Federal Register Volume 64, Number 190 (Friday, October 1, 1999)]
[Rules and Regulations]
[Page 53195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25556]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 900

[Docket No. 99N-1502]


Medical Devices: Quality Mammography Standards; Delay of 
Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; delay of effective date.

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SUMMARY: The Food and Drug Administration (FDA) published a direct 
final rule in the Federal Register of June 17, 1999 (64 FR 32404). The 
document notified the public of FDA's intention to amend the 
regulations that govern mammography quality standards to incorporate 
changes required by the Mammography Quality Standards Reauthorization 
Act. This document delays the effective date of the direct final rule.

EFFECTIVE DATE: The effective date of the direct final rule published 
at 64 FR 32404 is delayed until January 28, 2000.

FOR FURTHER INFORMATION CONTACT: Roger L. Burkhart, Center for Devices 
and Radiological Health (HFZ-240), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20857, 301-594-3332.

SUPPLEMENTARY INFORMATION: FDA solicited comments concerning the direct 
final rule for a 75-day period ending August 31, 1999. FDA stated that 
the effective date of the direct final rule would be on November 1, 
1999, 60 days after the end of the comment period, unless any 
significant adverse comment was submitted to FDA during the comment 
period. FDA did not receive any significant adverse comment.
     However, FDA has not yet received approval under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520) of the information 
collection requirements in this rule. Therefore, FDA is revising the 
effective date of this rule to January 28, 2000. By that date, FDA 
expects to have received clearance from the Office of Management and 
Budget for the information collection requirements in the rule. This 
document delays the effective date of the direct final rule.
     Therefore, under the Federal Food, Drug, and Cosmetic Act and 
under authority delegated to the Commissioner of Food and Drugs, notice 
is given that no significant adverse comments were filed on the June 
17, 1999, direct final rule. Accordingly, the amendments issued thereby 
are effective January 28, 2000.

    Dated: September 27, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-25556 Filed 9-30-99; 8:45 am]
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