[Federal Register Volume 64, Number 200 (Monday, October 18, 1999)]
[Notices]
[Pages 56210-56211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27029]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-1502]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Quality Mammography Standards; Lay Summaries 
for Patients

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
November 17, 1999.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

 Quality Mammography Standards; Lay Summaries for Patients

     The Mammography Quality Standards Act (Public Law 102-539) (the 
MQSA) was passed on October 27, 1992, to establish national quality 
standards for mammography. The MQSA required that, to lawfully provide 
mammography services after October 1, 1994, all facilities, except 
facilities of the Department of Veterans Affairs, shall be accredited 
by an approved accreditation body and certified by the Secretary of 
Health and Human Services (the Secretary). To become accredited and 
certified, a facility had to meet national quality standards to be 
established by the Secretary. The authority to establish these 
standards, to approve accreditation bodies, and to certify facilities 
was delegated by the Secretary to FDA. Facilities were initially 
accredited and certified if they met the standards contained within the 
interim rules issued by FDA in the Federal Register of December 21, 
1993 (58 FR 67558 and 67565), and amended by another interim rule 
published in the Federal Register on September 30, 1994 (59 FR 49808). 
More comprehensive standards were proposed by FDA in the Federal 
Register of April 3, 1996 (61 FR 14856, 61 FR 14870, 61 FR 14884, 61 FR 
14898, and 61 FR 14908). After some revision in response to the 
approximately 8,000 comments received on the proposed rule, a final 
rule amending part 900 (21 CFR part 900) was published in the Federal 
Register of October 28, 1997 (62 FR 55852) (hereinafter referred to as 
the October 1997 final rule). The effective date of most of the new 
standards contained within the final rule was April 28, 1999, but a few 
will not become effective until October 28, 2002.
     On October 9, 1998, the Mammography Quality Standards 
Reauthorization Act (MQSRA) (Public Law 105-248) became law. The basic 
purpose of the MQSRA was to extend the authorities established by the 
MQSA until September 30, 2002. However, the MQSRA also contained a 
requirement that was significantly different from the corresponding 
requirement in the October 1997 final rule. Although this MQSRA 
requirement became effective on April 28, 1999, FDA decided to amend 
the final rule to incorporate the change. The purpose of this amendment 
is to provide to the mammography facilities the convenience of being 
able to find all of the quality standards within a single document 
instead of having to consult both the October 1997 final rule and the 
MQSRA and to avoid confusion as to the applicable reporting 
requirement.
     This regulation merely implements a statutory information 
collection requirement; there is no additional burden attributable to 
the regulation. This rule would conform the requirements of this 
section with the requirement of section 6 of Public Law 105-248 which 
states that: ``(IV) whether or not such a physician is available or 
there is no such physician, a summary of the written report shall be 
sent directly to the patient in terms easily understood by a lay 
person.'' To produce the required lay summary, the

[[Page 56211]]

mammography facilities will review the medical report of each patient's 
examination and collect from it the necessary information.
     Section 900.12(c)(2) requires that each mammography facility shall 
send each patient a summary of the mammography report written in lay 
terms within 30 days of the mammographic examination. If assessments 
are ``Suspicious'' or ``Highly suggestive of malignancy,'' 
Sec. 900.12(c)(2) requires that the facility shall make reasonable 
attempts to ensure that the results are communicated to the patient as 
soon as possible.
     In the Federal Register of June 17, 1999, FDA published a direct 
final rule (64 FR 32404) and a companion proposed rule (64 FR 32443). 
FDA invited interested persons to comment on the direct final rule and 
companion proposed rule by August 31, 1999. FDA received no comments.
     FDA estimates the burden of this collection of information as 
follows:

               Table 1.--Estimated Annual Reporting Burden
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                         Annual
 21 CFR     No. of     Frequency      Total      Hours per
Section  Respondents      per         Annual      Response   Total Hours
                        Response    Responses
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900.12(        9,800        4,080   39,984,000    5 minutes    3,332,000
 c)(2)
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\1\ There are no capital costs or operating and maintenance costs
  associated with this collection of information.

     FDA estimates that there are 9,800 facilities performing 
mammography in the United States. FDA also estimates that these 
facilities perform a total of 40 million mammography examinations in a 
year. In 90 percent of these cases, the notification to the patient can 
be established by a brief standardized letter to the patient. FDA 
estimates that preparing and sending this letter will take 
approximately 5 minutes. In the 10 percent of the cases in which there 
is a finding of ``Suspicious'' or ``Highly suggestive of malignancy,'' 
the facility would be required to make reasonable attempts to ensure 
that the results are communicated to the patients as soon as possible. 
FDA believes that this requirement can be met by a 5 minute call from 
the health professional to the patient. Thus, the estimated burden is 
3,332,000 (39,984,000 x 1/12 hour).

    Dated: October 12, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-27029 Filed 10-15-99; 8:45 am]
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