[Federal Register Volume 64, Number 116 (Thursday, June 17, 1999)]
[Proposed Rules]
[Pages 32443-32447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15293]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 900

[Docket No. 99N-1502]


Quality Mammography Standards; Companion Document to Direct Final 
Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its regulations governing mammography. The purpose of the amendments is 
to incorporate changes required by the Mammography Quality Standards 
Reauthorization Act (MQSRA). This proposed rule is a companion document 
to the direct final rule published elsewhere in this issue of the 
Federal Register.

DATES: Comments on this proposal must be received by August 31, 1999. 
If FDA receives no significant adverse comment on the provisions of 
these regulations within the specified comment period, the agency 
intends to publish a document confirming the effective date of the 
final rule in the Federal Register within 30 days after the comment 
period on the direct final rule ends. The direct final rule will be 
effective November 1, 1999.

ADDRESSES: Submit written comments on the proposed rule to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

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: This proposed rule is a companion to the 
direct final rule published in the final rules section of this issue of 
the Federal Register. This companion proposed rule is identical to the 
direct final rule. This proposed rule will provide a procedural 
framework to finalize the rule in the event the agency receives a 
significant adverse comment and the direct final rule is withdrawn. FDA 
is publishing the direct final rule because the rule contains direct 
incorporations of statutory mandates, and FDA anticipates that it will 
receive no significant adverse comments. If no significant comment is 
received in response to the direct final rule, no further action will 
be taken related to this proposed rule. Instead, FDA will publish a 
confirmation document within 30 days after the comment period ends 
confirming that the direct final rule will go into effect no later than 
135 days after publication. Additional information about FDA's direct 
final rulemaking procedures is set forth in a guidance published in the 
Federal Register of November 21, 1997 (62 FR 62466).
    If FDA receives significant adverse comments regarding this rule, 
the agency will publish a document withdrawing the direct final rule 
within 30 days after the comment period ends and will proceed to 
respond to the comments under this rule using usual notice-and-comment 
procedures. The comment period for this companion proposed rule runs 
concurrently with the direct final rule's comment period. Any comments 
received under this companion proposed rule will also be considered as 
comments regarding the direct final rule. A significant adverse comment 
is defined as a comment that explains why the rule would be 
inappropriate, including challenges to the rule's underlying premise or 
approach, or would be ineffective or unacceptable without a change. It 
should be remembered, however, that the requirements themselves were 
established by the MQSRA. FDA must implement these new statutory 
provisions.
    In determining whether a significant adverse comment is sufficient 
to terminate a direct final rulemaking, FDA will consider whether the 
comment raises an issue serious enough to warrant a substantive 
response in a note-and-comment process. Comments that are frivolous, 
insubstantial, or outside the scope of the rule will not be considered 
a significant adverse comment under this procedure. For example, a 
comment recommending a rule change in addition to the rule will not be 
considered a significant adverse comment, unless the comment shows how 
the rule would be ineffective without the additional change. In 
addition, if a significant adverse comment applies to an amendment, 
paragraph, or section of this rule and that provision can be severed 
from the remainder of the rule, FDA may adopt as final those provisions 
of the rule that are not the subject of a significant adverse comment.

I. Background

    The Mammography Quality Standards Act (the MQSA) (Pub. L. 102-539) 
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 58 FR 67565), 
and amended by another interim rule published in the Federal Register 
of September 30, 1994 (59 FR 49808). More comprehensive standards were 
proposed by FDA in the Federal Register of April 3, 1996 (61 FR 14856,

[[Page 32444]]

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 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 October 1997 final rule is April 28, 
1999, but a few will not become effective until October 28, 2002.
    On October 9, 1998, the MQSRA (Pub. L. 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 will become effective on April 28, 1999, with or without 
the amendment of the final rule, FDA is proposing to amend the final 
rule to incorporate the change. The purpose of this proposed 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.
    Other provisions of the MQSRA clarify the basis for some of the 
requirements contained within the October 1997 final rule. FDA is also 
amending the October 1997 final rule to conform its wording of those 
requirements to that of the statute.

II. Changes in the Regulations

A. Reporting Requirements

    Section 900.12(c)(2) (21 CFR 900.12(c)(2)) of the October 1997 
final rule describes the requirements for communicating mammography 
results to the patients. As published in the October 1997 final rule, 
these requirements mandated that each mammography facility have a 
system to ensure that the results of each examination are communicated 
to the patient in a timely manner. Patients without a referring health 
care provider were to be sent the report of the examination (as 
described in Sec. 900.12(c)(1)) directly by the mammography facility, 
along with a written notification or summary of the results in lay 
terms. It was further required by the October 1997 final rule that such 
self-referred patients should be referred to a health care provider 
when clinically indicated.
    In the case of patients with a referring health care provider, 
Sec. 900.12(c)(3) required that the health care provider receive the 
report of the examination. The facility's system for ensuring that 
results reached the patient could utilize the services of that health 
care provider to achieve that goal. There was no specific requirement 
that a summary in lay terms be provided to the patient with a referring 
health care provider.
    The MQSRA amended the MQSA to specifically require that all 
patients, not just self-referred patients, receive directly from the 
mammography facility, a summary of the written report in terms easily 
understood by a lay person. As previously noted, this MQSRA requirement 
will go into effect on April 28, 1999. FDA is proposing to amend 
Sec. 900.12(c)(2) to incorporate this new requirement.

B. Clarifications

    The MQSRA at several points clarified the provisions of the MQSA 
upon which certain requirements of the interim and final rules were 
based. In contrast to the change in the patient reporting requirements, 
these clarifications became effective on October 9, 1998, the date on 
which the MQSRA became law. FDA is proposing to amend the regulations 
to similarly clarify the wording of the October 1997 final rule on 
these points.
1. Review Physicians
    The most important function of the accreditation bodies approved by 
FDA is to conduct a quality review of clinical images submitted by 
facilities seeking accreditation. This review is the key factor in 
determining if the facility should be accredited and then certified. It 
has been recognized from the start of the MQSA program that the 
physicians used by the accreditation bodies to review the clinical 
images submitted by the facilities should meet qualifications beyond 
those needed to serve as interpreting physicians in mammography 
facilities. All accreditation bodies applying to FDA for approval must 
demonstrate that their reviewing physicians have the high 
qualifications necessary to perform such reviews before approval is 
given.
    In section 4, the MQSRA emphasized these points by defining the 
physicians reviewing clinical images for the accreditation bodies as 
``review physicians.'' In the MQSRA definition, it is further 
recognized that the accreditation bodies can establish, with FDA 
approval, additional qualifications for these review physicians beyond 
the qualifications applicable to interpreting physicians in mammography 
facilities.
    FDA is proposing to add Sec. 900.2(yy) to incorporate the MQSRA 
definition of ``review physician'' into the final rule. FDA is further 
proposing to amend Sec. 900.4 in order to use the term review physician 
at the appropriate points. In addition, since this term could be 
confused with the term ``reviewing interpreting physician,'' presently 
used in connection with the requirements for the mammography audit, FDA 
is proposing to change the term, ``reviewing interpreting physician'' 
to ``audit interpreting physician'' in Sec. 900.12(f).
2. Patient Notification
    The October 1997 final rule at Sec. 900.12(j) states that if FDA 
determines that any activity related to the provision of mammography at 
a facility presents a sufficiently serious risk to human health, the 
agency may require the facility to notify the patients, their 
physicians, and/or the public of actions that may be taken to minimize 
this risk. This provision was established to aid FDA in fulfilling its 
general responsibility under the MQSA to inform the public about 
facilities against which the agency has been required to take action 
for failure to meet the quality standards. In section 10(a), the MQSRA 
provided a specific statement of the agency's authority to require 
patient notification. FDA is proposing to amend the wording of 
Sec. 900.12(j) to bring it into conformance with the wording of the 
MQSRA on this point.

III. Environmental Impact

    The agency has determined under 21 CFR 25.34(c) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IV. Analysis of Impacts

    FDA has examined the impacts of these proposed amendments under 
Executive Order 12866, under the Regulatory Flexibility Act (5 U.S.C. 
601-612), and under the Unfunded Mandates Reform Act (Pub. L. 104-4). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The Regulatory 
Flexibility Act requires agencies to analyze the impact of a rule on 
small entities. The Unfunded

[[Page 32445]]

Mandates Reform Act requires (in section 201) that agencies prepare an 
assessment of anticipated costs and benefits before enacting any rule 
that may result in an expenditure in any one year by State, local, and 
tribal governments, in the aggregate, or by the private sector of $100 
million (adjusted annually for inflation).
    As previously noted, the proposed amendments explained under 
section II.B of this document merely clarify provisions already 
contained within the October 1997 final rule. The impacts of the 
provisions of that final rule were discussed in the preamble of the 
final rule (62 FR 55852 at 55961), and are unchanged by the 
clarifications. Any economic impact of the proposed amendments is 
related solely to the change in the patient reporting requirement 
mandated by the MQSRA. Given the statutory basis for extending this 
requirement to all mammography facilities effective April 28, 1999, FDA 
did not consider alternatives to implementing the requirements.
    In the October 1997 final rule, FDA estimated that there were 9,800 
mammography facilities that would be considered small. Moreover, FDA 
previously estimated the impact of a requirement for sending a lay 
summary of results to all patients during the development of its 
proposed rule of April 3, 1996 (61 FR 14856), although that requirement 
was removed from the October 1997 final rule in response to public 
comments (Ref. 1). FDA believes that these estimates remain accurate.
    The earlier estimate concerning the impact of required lay 
summaries was based upon the assumption that an adequate lay summary of 
results could be provided in the great majority of cases in a brief, 
standardized format. Using this assumption, it was estimated that the 
compliance cost per examination would be $0.94, including the labor of 
the office worker and the cost of postage.
    To convert this per examination cost to a national total, it was 
necessary to make several other assumptions. Using the best data and 
expert opinion available at the time, it was estimated that 
approximately 25 million mammography examinations were conducted 
annually in this country. Of this, it was estimated that 7.7 percent or 
1,925,000 were examinations of self-referred patients. Because 
facilities were already required by the MQSA (and by the interim rule) 
to provide a lay summary of results to self-referred patients, that 
portion of the cost of sending lay summaries had already been included 
in the impact estimates made in association with the development of the 
interim rule of October 27, 1993.
    There remained then approximately 23,075,000 patients for which 
this was potentially a new requirement. However, it was further 
estimated that 40 percent of the patients were already receiving a lay 
summary in some form from the facility at which they received their 
examinations. Thus, the new requirement would lead to additional lay 
summaries in only 60 percent of the referred examinations or 
approximately 13,845,000. At $0.94 a lay summary, the added cost would 
be slightly over $13 million a year.
    Two major changes have occurred since the information upon which 
these estimates were based was collected in late 1995. Most 
significantly, through FDA's activities and those of other private and 
government groups, public awareness of the need for regular mammography 
examinations and public confidence that a high quality examination will 
be received have both increased. As a result, the number of 
examinations given per year has increased to an estimated 40 million. 
This requires increasing the costs estimated previously by 60 percent. 
Postage rates have also gone up $0.01 per letter thus the cost per lay 
summary would increase from $0.94 to $0.95. The combined impact of 
these two changes is to increase the estimate of the annual incremental 
costs to meet this proposed new requirement to approximately $21 
million.
    For the great majority of cases, the assumption that the lay 
summaries can be provided in brief, standardized format is valid. 
However, in approximately 10 percent of the cases, the overall 
assessment of the findings is expected to be ``suspicious'' or ``highly 
suggestive of malignancy.'' In such cases, the facility is required to 
``make reasonable attempts to ensure that the results are communicated 
to the patients as soon as possible.''
    Facilities that accept self-referred patients are already required 
by the final rule to make such attempts for cases with an overall 
assessment of ``suspicious'' or ``highly suggestive of malignancy.'' 
Based upon the assumption that the attempt would involve a 5 minute 
telephone conversation of the interpreting physician with the patient, 
a cost of $8.93 per examination was estimated. This cost would be in 
addition to the $0.95 estimated cost for the written lay summary which 
would still need to be sent. Assuming that this would be a new cost for 
10 percent of the 60 percent of the referred patients among the 40 
million receiving examinations annually, the incremental cost for these 
contacts is approximately $21.4 million.
    The total annual incremental cost due to this proposed new 
requirement, therefore, would be approximately $42.4 million. 
Previously, the annual cost for compliance with the interim and final 
MQSA rules was estimated at $61.5 million (Ref. 2). Adding the cost of 
compliance with this proposed new requirement brings the total annual 
cost of compliance with the final rule as amended to approximately 
$103.9 million.
    Compliance with the proposed new requirement would also be expected 
to increase the benefits from mammography. Mammography is the most 
effective technique presently available for the early detection of 
breast cancer. Early detection of breast cancer followed by prompt 
treatment can avert mortalities that can result if treatment is delayed 
until the cancer reaches a more advanced stage. In addition, the cost 
and severity of the treatment methods will in general be less when the 
cancer is treated at an early stage. Even in cases where the assessment 
is negative, there will be an expected benefit arising from relieving 
the anxiety of the patient about the possible results of the 
examination through prompt reporting of results to her. But for these 
benefits to be gained, the patient must be informed of the results of 
her examination so that necessary followup actions can be promptly 
taken. Unfortunately, although it is not possible to make a 
quantitative estimate of the number of such cases, there have been 
frequent complaints about patients receiving the results of their 
examinations after an undue delay or not at all. Studies have also 
shown that direct communication of results to the patient by the 
mammography facility (as compared to traditional communication 
procedures where the facility communicates only with the referring 
provider), produces an improvement in compliance with followup 
recommendations (Ref. 3). The new requirement should thus add to the 
benefits expected from interim and final rules, which were previously 
estimated to range from $284 to $408 million (61 FR 55986), primarily 
due to a gain in averted mortalities (Ref. 2).
    Based on these analyses, FDA has determined that the rule is 
consistent with the principles set forth in the Executive Order, the 
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act. The 
wording of the requirement related to sending lay summaries to referred 
patients directly parallels that of the MQSRA and so, in accordance 
with the Executive Order, maximizes the net benefits to the extent

[[Page 32446]]

allowed by that statute. Similarly, in accordance with the Regulatory 
Flexibility Act, the impact of the rule on small entities has been 
analyzed. Finally, as noted previously, the incremental annual 
expenditures (beyond those already incurred from the previous interim 
and final rules) required by the rule are estimated at $42.4 million 
and thus do not exceed $100 million in 1 year so the rule does not come 
under the requirements of the Unfunded Mandates Reform Act.

V. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The title, description, and respondent description of the 
information collection provisions are shown below with an estimate of 
the annual reporting and recordkeeping burden. Included in the estimate 
are the times for reviewing the instructions, searching existing data 
sources, gathering and maintaining the data needed, and completing and 
reviewing each collection of information.
    FDA invites comments on: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Title: Lay Summary of Examination Results to Patients
    Description: This proposed rule would merely implement a statutory 
information collection requirement; there is no additional burden 
attributable to the regulation. The proposed rule would conform the 
requirements of this section with the requirement of section 6 of Pub. 
L. 105-248 that states: ``(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 mammography 
facilities will review the medical report of each patient's examination 
and collect from it the necessary information.
    Respondent Description: Businesses and other for-profit 
organizations, nonprofit organizations.
    For consistency with the direct final rule to which this proposed 
rule is a companion, FDA is following the PRA comment procedures for 
direct final rules in this proposed rule. As provided in 5 CFR 
1320.5(c)(1), collections of information in a direct final rule are 
subject to the procedures set forth in 5 CFR 1320.10. Interested 
persons and organizations may submit comments on the information 
collection provisions of this proposed rule by August 31, 1999, to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. At the close of the 75-day 
comment period, FDA will review the comments received, revise the 
information collection provisions as necessary, and submit these 
provisions to OMB for review. FDA will publish a notice in the Federal 
Register when the information collection provisions are submitted to 
OMB, and an opportunity for public comment to OMB will be provided at 
that time. Prior to the effective date of the direct final rule, FDA 
will publish a notice in the Federal Register of OMB's decision to 
approve, modify, or disapprove the information collection provisions. 
An agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number.

VI. References

    The following references have been placed on display at the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Eastern Research Group, ``Cost and Benefit Analysis of 
Regulations Under the Mammography Quality Standards Act of 1992-
Preliminary Final,'' March 14, 1996.
    2. Eastern Research Group, ``Economic Impact Analysis of 
Regulations Under the Mammography Quality Standards Act of 1992-
Final,'' October 7, 1997.
    3. Agency for Health Care Policy and Research (AHCPR), ``Quality 
Determinants of Mammography,'' AHCPR Pub. No. 95-0632, October 1994.

List of Subjects in 21 CFR Part 900

    Electronic products, Health facilities, Medical devices, Radiation 
protection, Reporting and recordkeeping requirements, X-rays.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 900 be amended as follows:

PART 900--MAMMOGRAPHY

    1. The authority citation for part 900 continues to read as 
follows:
    Authority: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.
    2. Section 900.2 is amended by adding paragraph (yy) to read as 
follows:


Sec. 900.2  Definitions.

* * * * *
    (yy) Review physician means a physician who, by meeting the 
requirements set out in Sec. 900.4(c)(5), is qualified to review 
clinical images on behalf of the accreditation body.
    3. Section 900.4 is amended by revising the last sentence of 
paragraph (a)(4); and by revising paragraphs (c)(3)(ii), (c)(5) 
introductory text, (c)(5)(i), (c)(5)(ii), and (c)(6)(ii) to read as 
follows:


Sec. 900.4  Standards for accreditation bodies.

    (a) * * *
    (4) * * * Such individuals who review clinical or phantom images 
under the provisions of paragraphs (c) and (d) of this section or who 
visit facilities under the provisions of paragraph (f) of this section 
shall not review clinical or phantom images from or visit a facility 
with which such individuals maintain a relationship, or when it would 
otherwise be a conflict of interest for them to do so, or when they 
have a bias in favor of or against the facility.
* * * * *
    (c) * * *
    (3) * * *
    (ii) All clinical images submitted by a facility to the 
accreditation body shall be reviewed independently by two or more 
review physicians.
* * * * *
    (5) Review physicians. Accreditation bodies shall ensure that all 
of their review physicians:
    (i) Meet the interpreting physician requirements specified in 
Sec. 900.12(a)(1) and meet such additional requirements as have been 
established by the accreditation body and approved by FDA;
    (ii) Are trained and evaluated in the clinical image review 
process, for the types of clinical images to be evaluated by a review 
physician, by the accreditation body before designation as review 
physicians and periodically thereafter; and
* * * * *
    (6) * * *
    (ii) If a review physician identifies a suspicious abnormality on 
an image

[[Page 32447]]

submitted for clinical image review, the accreditation body shall 
ensure that this information is provided to the facility and that the 
clinical images are returned to the facility. Both shall occur no later 
than 10-business days after identification of the suspected 
abnormality.
* * * * *
    4. Section 900.12 is amended by revising paragraphs (c)(2) and 
(f)(3) and the first sentence of paragraph (j)(2) to read as follows:


Sec. 900.12  Quality standards.

* * * * *
    (c) * * *
    (2) Communication of mammography results to the patients. Each 
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,'' 
the facility shall make reasonable attempts to ensure that the results 
are communicated to the patient as soon as possible.
    (i) Patients who do not name a health care provider to receive the 
mammography report shall be sent the report described in paragraph 
(c)(1) of this section within 30 days, in addition to the written 
notification of results in lay terms.
    (ii) Each facility that accepts patients who do not have a health 
care provider shall maintain a system for referring such patients to a 
health care provider when clinically indicated.
* * * * *
    (f) * * *
    (3) Audit interpreting physician. Each facility shall designate at 
least one interpreting physician to review the medical outcomes audit 
data at least once every 12 months. This individual shall record the 
dates of the audit period(s) and shall be responsible for analyzing 
results based on this audit. This individual shall also be responsible 
for documenting the results and notifying other interpreting physicians 
of their results and the facility aggregate results. If followup 
actions are taken, the audit interpreting physician shall also be 
responsible for documenting the nature of the followup.
* * * * *
    (j) * * *
    (2) If FDA determines that the quality of mammography performed by 
a facility, whether or not certified under Sec. 900.11, was so 
inconsistent with the quality standards established in this section as 
to present a significant risk to individual or public health, FDA may 
require such facility to notify patients who received mammograms at 
such facility, and their referring physicians, of the deficiencies 
presenting such risk, the potential harm resulting, appropriate 
remedial measures, and such other relevant information as FDA may 
require. * * *

    Dated: June 9, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-15293 Filed 6-16-99; 8:45 am]
BILLING CODE 4160-01-F