[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]
BILLING CODE 4160-01-F
