Medical Devices: Quality Mammography Standards; Delay of Effective Date

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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