[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14898-14908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7832]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR PART 900
[Docket No. 95N-0215]
RIN 0910-AA24

Quality Standards and Certification Requirements for Mammography 
Facilities; Personnel Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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[[Page 14899]]


SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
the mammography facility standards by modifying and adding to the 
personnel requirements for interpreting physicians, radiologic 
technologists, and medical physicists who perform mammography services. 
In addition to the statutory framework and the expertise and research 
of FDA personnel, the agency is proposing this rule based on advice 
provided by the National Mammography Quality Assurance Advisory 
Committee (NMQAAC) and public comments received in response to the 
interim regulations. This action is being taken to ensure that all 
personnel involved in mammography meet at least the minimum 
requirements for providing safe, accurate, and reliable mammography. 
This is the fourth of five proposed rules being published concurrently.

DATES: Written comments on this proposed rule by July 2, 1996.
    Written comments on the information collection requirements should 
be submitted by May 3, 1996. The agency is proposing that any final 
rule based on this proposed rule become effective 1 year after its date 
of publication in the Federal Register.

ADDRESSES: Submit written comments on this proposed rule to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857. The Regulatory Impact 
Study (RIS) is available at the Dockets Management Branch for review 
between 9 a.m. and 4 p.m., Monday through Friday. Requests for copies 
of the RIS should be submitted to the Freedom of Information Staff 
(HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, 
Rockville, MD 20857.
    Submit written comments on the information collection requirements 
to the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Charles K. Showalter, Center for 
Devices and Radiological Health (HFZ-240), Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3332.

SUPPLEMENTARY INFORMATION:

I. Background

    This proposal is the fourth of five related proposed rules 
published in this issue of the Federal Register to amend interim 
regulations published on December 21, 1993 (58 FR 67558 and 58 FR 
67565), implementing the Mammography Quality Standards Act of 1992 (the 
MQSA). The first proposed rule entitled ``Quality Mammography 
Standards; General Preamble and Proposed Alternative Approaches'' 
contains background information and a summary of the preliminary 
analysis of the costs and benefits of all of these proposed rules, a 
description of the information collection requirements, proposed 
revisions to Sec. 900.1 Scope and Sec. 900.2 Definitions, and proposed 
alternative approaches to mammography quality standards and a request 
for comments on the proposed alternatives.

II. Provisions of the Proposed Rule

A. Development of the Proposed Regulation

    This proposed rule establishes the personnel qualification 
standards that the staff of each mammography facility must meet in 
order to comply with requirements under the MQSA. As in the development 
of the interim regulations, FDA has been guided by the requirements of 
this statute and its stated legislative intent to guarantee access to 
safe and effective mammography services for all women in the United 
States (Ref. 1).
    In addition to the statutory framework and the expertise and 
research of FDA personnel, the agency relied upon three major sources 
of information in developing this proposed rule. The first source was 
the written comments received on the interim regulations. FDA received 
103 comments from individuals and organizations on the interim 
regulations. Included among the written comments were responses from 
professional organizations, medical facilities, State agencies, 
consumer groups, manufacturers, and individual physicians, medical 
physicists, and radiologic technologists.
    Drafts of this proposed rule were also discussed with the NMQAAC, 
particularly at the February 1994 and January 1995 public meetings with 
the agency. The members of the NMQAAC include interpreting physicians, 
medical physicists, radiologic technologists, representatives of State 
agencies, and consumer representatives. Consultants to the Committee 
and guests invited to attend the meetings in recognition of their 
expertise in mammography also participated in these discussions. In the 
Federal Register of January 26, 1995 (60 FR 5152), the agency published 
a notice of availability of the draft of the proposed rule that was 
discussed with the NMQAAC.
    Finally, the problems with the interim regulation were discussed 
with many of the individuals who currently perform annual inspections 
of mammography facilities under the MQSA to determine whether minimum 
quality standards are being achieved. Most of these inspectors have 
extensive prior experience in the inspection of radiology facilities. 
After the MQSA inspections began in January 1995, the agency closely 
monitored the process and gathered information that was valuable for 
developing the proposed final regulations.

B. Interpreting Physicians

    The proposed regulation for interpreting physicians generally 
clarifies the requirements issued under the interim regulations and 
adds some new requirements. Although neither a national standard nor a 
continuing competency test for mammography interpretation currently 
exists, the proposed training and experience requirements for 
interpreting physicians will provide minimum standards to help ensure 
the reliability and accuracy of interpretation of mammograms for women 
throughout the country.
    As discussed below, the quality standards proposed by FDA for 
interpreting physicians are divided into four general sections: Initial 
qualifications; continuing experience and education; exceptions; and 
reestablishing qualifications.
1. General Comments
    Two comments expressed concern that providers in rural areas would 
have difficulty meeting the requirements of the interim regulations. 
They suggested that allowance should be made for such facilities, 
either through lowering the standards for rural facilities or 
establishing a longer phase-in period. One of these comments also 
stated that it would be helpful if the Department of Health and Human 
Services monitored the effect of the rules on rural providers.
    Both FDA and NMQAAC are concerned about the impact of the MQSA on 
access to mammography in rural areas. However, both the agency and 
NMQAAC believe that the standards should not be lower for certain 
facilities. One of the primary goals of the MQSA is to ensure that all 
women receive at least the same minimum standard of care, no matter 
which facility they use. However, one of the specific duties that the 
MQSA requires of NMQAAC is to determine whether there exists a shortage 
of mammography facilities or health professionals in any areas and to 
determine the effects of the quality standards on access to mammography

[[Page 14900]]
services in such areas. This study already has begun and the results 
will be published upon completion.
2. Initial Qualifications
    The first qualification for an interpreting physician under the 
MQSA is a State license to practice medicine (proposed 
Sec. 900.12(a)(1)(i)(A)).
    One comment stated that Sec. 900.12(a)(1)(i)(A) in the interim 
regulations was confusing and would appear to allow a facility to 
license a physician. Similarly, another comment stated that the 
licensing requirements of physicians practicing in Federal facilities 
are unclear.
    In response, FDA notes that a facility cannot license a physician 
to practice medicine. Licensing of physicians is a State function. 
Proposed Sec. 900.12(a)(1)(i) simply requires the interpreting 
physician to have a State license to practice medicine. However, if the 
State in which the mammography facility is located is different from 
the State that issued the license, a physician may have to meet 
additional State requirements in order to practice medicine lawfully at 
that facility. With respect to physicians practicing in Federal 
facilities, a valid State license from any State is sufficient. 
However, the Federal employee would be unable to practice outside the 
Federal facility unless the physician also fulfilled the requirements 
of that State for the practice of medicine.
    Proposed Sec. 900.12(a)(1)(i)(B) provides two pathways to establish 
the second initial qualification: Board certification or documented 
training in interpreting mammograms. The training shall include 
radiation physics (including radiation physics specific to 
mammography), radiation effects, and radiation protection.
    One comment recommended that FDA accept both American and Canadian 
boards as certifying bodies.
    FDA does accept certification from both American and Canadian 
boards. Currently, FDA recognizes certification in Diagnostic Radiology 
and Radiology by the American Board of Radiology (ABR), the American 
Osteopathic Board of Radiology (AOBR), and the Royal College of 
Physicians and Surgeons of Canada.
    Another comment asked that two British radiology boards be added to 
the list of bodies designated by FDA as eligible to certify 
interpreting physicians: Fellow of the Royal College of Radiologists 
(FRCR) and, Diploma in Medical Radiodiagnosis (DMRD) from the Royal 
College of Physicians and Surgeons of England.
    NMQAAC discussed but did not recommend including other bodies to 
certify interpreting physicians at this time because there was 
insufficient information about the procedures and requirements for 
obtaining board certification from other bodies. FDA has not added 
additional bodies to its list of certifying bodies because FDA agrees 
that it has insufficient information at this time.
    One comment stated that certifying bodies for interpreting 
physicians should be listed in the regulations. Another comment noted 
that the interim regulations do not indicate the particular bodies that 
have or will be designated by FDA as eligible to certify interpreting 
physicians and noted that approval of inappropriate certifying bodies 
could result in poorly qualified physicians reading and interpreting 
mammograms. The comment suggested that guidelines are needed regarding 
the certification of interpreting physicians.
    FDA believes that it is best not to codify the list of eligible 
certifying bodies in the regulation in order to be able to make changes 
to the list of certifying bodies in a timely manner each time a body 
must be added to or deleted from the list. FDA will add or delete names 
based upon the agency's determination that the body has in place and 
implements procedures and requirements that are adequate to ensure that 
interpreting physicians certified by the body are capable of satisfying 
the MQSA needs. Whenever possible, FDA intends to consult with the 
NMQAAC before making a determination about adding or removing a body 
from the list of those eligible to certify physicians. The list of 
currently eligible certifying boards is based upon FDA evaluation and 
consultation with NMQAAC, as described above. FDA will follow a similar 
policy with respect to its determination of eligibility for boards or 
organizations that certify radiologic technologists and medical 
physicists.
    One comment noted that his State's requirements for interpreting 
physicians are more stringent than the interim requirements and 
suggested that FDA may want to include the following language in the 
regulation (sic): ``require A.B.R. or A.O.B.R. certification or has 
successfully completed and graduated from an accredited radiology 
residency within the past 24 months.'' Another comment stated that FDA 
should give careful consideration before approving either the ABR or 
the AOBR to certify interpreting physicians. The comment further 
explained that if the ABR or AOBR certifies physicians based on ``board 
certification,'' many physicians who are not adequately trained in 
mammography automatically would be allowed to interpret mammograms.
    FDA recognizes that some earlier board examinations may not have 
included testing in mammography. FDA also recognizes that board 
certification that includes mammography cannot by itself ensure the 
accuracy of outcomes in clinical mammography practices. However, board 
certification is evidence that the physician is knowledgeable in the 
basics of diagnostic radiology and board certification serves as a 
foundation for the additional requirements specific to mammography that 
interpreting physicians must meet under FDA's interim and proposed 
regulations.
    Alternatively, proposed Sec. 900.12(a)(1)(i)(B) would permit 3 
months of documented formal training in mammography, including the 
interpretation of mammograms and other topics related to mammography, 
in place of board certification in diagnostic radiology. The other 
topics related to mammography include, but are not limited to: 
Radiation physics, including radiation physics specific to mammography; 
radiation effects; and radiation protection. The interim regulations 
require 2 months of documented full-time training. The agency is 
proposing an additional month of required training to reflect the 
increased emphasis that has been placed on mammography in residency 
programs.
    During discussions at an NMQAAC meeting, it was recommended that 
FDA require training in radiation physics specific to mammography 
instead of training in general radiation physics as the training 
required by the alternative pathway in proposed 
Sec. 900.12(a)(1)(i)(B). FDA agrees that mammography specific training 
is necessary, but also believes that general training in radiation 
physics is important for basic principles and should be retained as 
part of the requirements for the alternative pathway provided by 
proposed Sec. 900.12(a)(1)(i)(B). NMQAAC also suggested that all 
required training in physics be obtained from a physicist. However, the 
agency believes that this suggestion is too restrictive and would limit 
the availability of adequate training opportunities.
    The agency is proposing that the training in interpretation 
required for the alternative pathway be performed under the direct 
supervision of an interpreting physician who meets the MQSA 
requirements for an interpreting physician. It was recommended during 
NMQAAC discussions that there be additional qualifications for the

[[Page 14901]]
supervising physician beyond those required of an interpreting 
physician. For example, FDA could require supervising physicians to be 
qualified to offer continuing medical education (CME) credits. Again, 
the agency believes that this suggestion would be too restrictive and 
reduce the availability of effective training opportunities.
    One comment suggested having an alternative method for allowing a 
physician who is not a radiologist but who is experienced in 
interpreting film mammography to be certified and allowed to continue 
to interpret mammograms.
    The agency agrees and has proposed Sec. 900.12(a)(1)(i)(B) in order 
to provide an alternative to board certification for radiologists and 
physicians who are not radiologists, but who otherwise qualify.
    One comment stated that the alternate pathway to board 
certification in the interim regulations, requiring 2 months of 
training in the interpretation of mammograms, is not adequate. The 
comment stated that some type of board certification is necessary to 
ensure that women are receiving high quality interpretation of 
mammograms. Another comment advocated the addition of a proficiency 
examination, which would require a physician to demonstrate his or her 
ability to interpret mammograms, both at the point of the physician's 
initial certification and at periodic intervals to maintain that 
certification. The latter comment noted that academic achievement, 
although important, is not sufficient to ensure high quality 
mammography.
    The NMQAAC discussed the possibility of requiring that interpreting 
physicians undergo proficiency testing in mammography, but did not 
recommend such testing at this time. To date, sufficient data have not 
been compiled on existing levels of interpretive skills for 
interpreting physicians to determine whether there is a general need 
for proficiency testing. With respect to the adequacy of the training 
required under the alternate pathway, FDA is proposing to increase that 
requirement from 2 to 3 months of documented training in the 
interpretation of mammograms.
    Proposed Sec. 900.12(a)(1)(i)(C) requires 60 hours of documented 
continuing medical education credits in mammography for all 
interpreting physicians, including instruction in the interpretation of 
mammograms and training appropriate to each mammographic modality used 
in the interpreting physician's practice. At least 40 of these hours 
must be Category I CME credits and, to ensure that the physician has 
recent mammography education, at least 15 of these 40 Category I CME 
hours must have been acquired within the 3 years immediately preceding 
qualifying as an interpreting physician. Hours spent in residency 
specifically devoted to mammography will be considered as equivalent to 
Category I CME and will be accepted if documented in writing by the 
appropriate representative of the training institution.
    One comment stated that the interim regulations, which require 40 
hours of documented CME in mammography, are quite adequate to ensure 
that interpreting physicians have the training, expertise, and 
experience necessary to do mammographic interpretations.
    The agency believes that an increase to 60 hours is in keeping with 
current training trends and the emergence of new technologies.
    Proposed Sec. 900.12(a)(1)(i)(C) requires training in each 
mammographic modality employed in the interpreting physician's 
practice. FDA added this requirement because of the differences among 
imaging modalities (e.g., film screen and xeromammography) currently in 
use and emerging technologies, such as digital mammography. The agency 
believes that, before a physician begins to interpret images produced 
by a particular modality, he or she should have specific training in 
the interpretation of such images. FDA is proposing that at least 8 
hours of Category I CME credit be related to each mammographic modality 
used by the interpreting physician.
    FDA has also proposed, with the concurrence of NMQAAC, that the 
interpreting physician must have education in each of the following: 
basic breast anatomy; breast pathology and physiology; technical 
aspects of mammography (e.g., exposure factors, compression, 
positioning); quality assurance and quality control in mammography.
    One comment questioned whether ABR certified physicians are 
required to document 40 hours of initial education under the interim 
regulations.
    The interim regulations require this documentation from physicians 
using either of the two pathways and proposed Sec. 900.12(a)(1)(i)(C) 
would continue this requirement for the 60 hours of required initial 
training.
    Two comments asked what FDA will consider to be adequate 
documentation of the radiologist's training.
    A variety of documentation has and will be accepted (e.g., copy(s) 
of the license(s) to practice medicine, copy(s) of the certificate 
issued by certifying board(s), CME credit certificates). The agency 
previously issued guidance on adequate documentation under the interim 
regulations that will be revised, as needed, and made available when 
the final regulations are published. Such guidance does not bind the 
agency or the facility and facilities may choose to accept 
documentation that is not discussed in FDA guidance. However, FDA 
encourages facilities that plan to accept alternate documentation to 
discuss the matter in advance with FDA in order to avoid potential loss 
of time and resources. Upon inspection of the facility, in any 
situation in which documentation appears inadequate, the burden will be 
upon the employee and the facility to provide additional evidence to 
demonstrate the qualifications of personnel employed by the facility.
    One comment suggested that time spent in a residency program 
devoted to mammography should be documented by the residency program.
    FDA agrees and is proposing that the resident's training be 
documented in writing by the appropriate representative of the training 
institution.
    Proposed Sec. 900.12(a)(1)(i)(D) requires the qualifying physician 
to interpret at least 240 mammographic examinations under the direct 
supervision of a qualified interpreting physician within the 6 months 
immediately prior to fulfilling the initial qualifications as an 
interpreting physician. The intent of this requirement is to 
demonstrate recent supervised experience before the physician begins to 
interpret mammograms independently. Proposed Sec. 900.12(a)(1)(iii)(B) 
provides an exception from this prior 6-month timeframe for diagnostic 
radiology residents who become board certified at the first allowable 
time, as defined by the eligible certifying body of their choice. Such 
residents must still interpret at least 240 mammographic examinations 
in the last 2 years of residency under the direct supervision of a 
qualified interpreting physician.
    One comment expressed concern that the volume of films that must be 
read to achieve and maintain certification may have an unintended, 
negative impact on a physician working on a locum tenens basis, that 
is, a physician serving as a temporary replacement for another 
physician.
    In response, FDA notes that proposed Sec. 900.12(a)(1)(i)(D) is an 
initial requirement that need only be met once if the interpreting 
physician maintains his or her continuing experience requirements under 
proposed Sec. 900.12(a)(1)(ii).

[[Page 14902]]

3. Continuing Qualifications
    Proposed Sec. 900.12(a)(1)(ii)(A) is the first of the requirements 
established to ensure that interpreting physicians maintain their 
qualifications. Under this requirement, in order to continue to qualify 
under the MQSA, interpreting physicians must have read an average of at 
least 40 mammographic examinations a month during the previous 24 
months. Although the wording has changed somewhat from the interim 
rule, the proposed regulation is not substantially different from the 
interim requirement.
    There were numerous comments on this requirement in the interim 
regulations. Comments expressed concern about the difficulty in meeting 
this requirement in rural areas due to lack of volume at the facility. 
One comment expressed concern that the requirement may have a negative 
impact on physicians serving as temporary replacements for other 
physicians (i.e., on a locum tenens basis). Two comments suggested 
allowing the substitution of continuing education for this experience 
requirement, and one of these comments suggested that the physician be 
allowed to submit interpretations on a specified number of test 
mammograms in lieu of the 40 per month average and that the 
requirements could also be modified slightly to focus on the number of 
mammograms read per year, instead of per month. Another comment 
requested that rural x-ray departments be exempted from this 
requirement.
    As previously stated, FDA believes that all women, including those 
in rural areas, are entitled to the same quality of care, and the 
agency cannot support lower standards for particular facilities. The 
agency also believes, as discussed below, that it will not be difficult 
for most physicians to meet this continuing qualification, even for 
those in rural areas.
    The monthly average is to be maintained over a 24-month period. FDA 
selected 24 months to allow interpreting physicians a reasonable chance 
to maintain the required average. Physicians who are absent for a 
period of time, due to sabbaticals or other reasons, or who only read 
mammographic images during selected periods, because of their facility 
rotation schedule or employment on a locum tenens basis, will have the 
opportunity to read enough images during some portions of the 24-month 
period to maintain the required average. The agency also wants to 
clarify that this is a physician requirement, not a facility 
requirement. Interpreting physicians who provide services to low 
workload facilities can read films at more than one facility to attain 
the required average. Double reading of images (2 or more physicians 
interpreting the same mammogram) is also accepted as a way of meeting 
this requirement. However, the agency excludes from its definition of 
double reading the interpretation of the same mammogram more than once 
by a same physician. For all of these reasons, the agency believes 
there will not be widespread difficulty in meeting this requirement.
    One comment suggested that the agency develop something besides an 
artificial number to tell whether or not a radiologist is able to do a 
good job.
    FDA recognizes that numbers alone cannot guarantee competency, but 
believes that the experience a radiologist accumulates through 
interpreting a certain minimum number of films is a necessary aspect of 
the qualification process. Elsewhere in this issue of the Federal 
Register, FDA is proposing requirements for the establishment and 
implementation of a medical outcomes' audit for individual physicians. 
This type of monitoring can further improve the reliability, clarity, 
and accuracy of interpretation of mammograms.
    One comment suggested that FDA establish a maximum number of images 
that the interpreting physician would be allowed to read in a given 
period of time.
    FDA does not believe there is any evidence to support a need to 
establish such a limit.
    Proposed Sec. 900.12(a)(1)(ii)(B) requires interpreting physicians 
to further maintain their skills by teaching or completing at least 15 
Category I CME credits in mammography in the previous 3 years. Category 
I CME credits are generally those that offer more formal training and 
provide a solid basis for the ongoing maintenance and growth of the 
interpretive skills of the physician.
    The interim regulations require interpreting physicians to 
participate in education programs, either by teaching or completing an 
average of at least five CME credits in mammography per year. There 
were numerous comments on this requirement in the interim regulations, 
most of which focused on the lack of a specified average period. Some 
comments suggested that it should be 15 hours over a 3-year period.
    Proposed Sec. 900.12(a)(1)(ii)(B) addresses these concerns by 
establishing a 3-year period of time for determining the yearly 
average. FDA has proposed that the credits be in category I CME in 
order to ensure that continuing education is more formal and 
contributes to the development of the physician. The section also 
requires that at least 6 of the CME hours be in each mammographic 
modality used in the interpreting physician's practice. Therefore, the 
CME hours required for an interpreting physician who practices in a 
facility that employs more than 2 modalities will be in excess of the 
minimum requirement of 15 hours of category I CME.
     Proposed Sec. 900.12(a)(1)(ii)(C) requires that, before using a 
new mammographic modality in his or her practice, the interpreting 
physician must have at least 8 hours of training with that modality. 
This education requirement is a logical parallel to the requirement in 
proposed Sec. 900.12(a)(1)(i)(C) that the physician must have at least 
8 hours of training in each modality used in his or her practice when 
the initial qualifications are first met.
4. Exceptions
    Proposed Sec. 900.12(a)(1)(iii) would allow exceptions to some of 
these requirements in certain specific cases. In order to ensure 
continuing and uninterrupted availability of mammography services, FDA 
is proposing to permit those interpreting physicians who have qualified 
under the interim regulations to continue to interpret mammograms, 
provided that they maintain the continuing experience and education 
requirements in proposed Sec. 900.12(a)(1)(ii)(A) through 
(a)(1)(ii)(C). Proposed Sec. 900.12(a)(1)(iii)(A) would exempt these 
physicians from the new and additional initial requirements proposed in 
Sec. 900.12(a)(1)(i). The additional month of training in proposed 
Sec. 900.12(a)(1)(i)(B) for physicians using the alternative pathway, 
the additional 20 hours of CME in proposed Sec. 900.12(a)(1)(i)(C), the 
8 Category I CME credits in new modalities in proposed 
Sec. 900.12(a)(1)(i)(C), and the requirement that 15 Category I CME 
credits must have been acquired in the 3 years immediately before 
qualifying as an interpreting physician in proposed 
Sec. 900.12(a)(1)(i)(C).
    Proposed Sec. 900.12(a)(1)(iii)(B) allows another exception in 
response to NMQAAC's concern that the initial experience requirement in 
proposed Sec. 900.12(a)(1)(i)(D) may pose a problem in some diagnostic 
residency programs that schedule mammography rotations in the first 6 
months of the last year. This exception permits a resident to satisfy 
the requirement of proposed Sec. 900.12(a)(1)(i)(D) by having 
interpreted at least 240 mammographic examinations under the direct 
supervision of a qualified interpreting

[[Page 14903]]
physician during the last 2 years of the residency. FDA has included 
this exception only for the diagnostic radiology resident who 
successfully becomes board certified at the earliest opportunity 
provided by an eligible certifying board (``first allowable time'').
    For the physician who qualifies for the exception under proposed 
Sec. 900.12(a)(1)(iii)(B), the continuing education and experience 
requirements of proposed Sec. 900.12(a)(1)(ii)(A) through (a)(1)(ii)(C) 
would begin from the date of that physician's board certification in 
diagnostic radiology, provided the other initial requirements are 
satisfied. If the physician does not become board certified at the 
first allowable time by the certifying board, then this physician must 
interpret 240 mammographic examinations under the direct supervision of 
a qualified interpreting physician within a period of 6 months 
immediately prior to initial qualification as an interpreting 
physician. The ``first allowable time'' means the earliest time a 
physician is eligible to take the diagnostic radiology boards of an 
eligible certifying body. Because the ``first allowable time'' a 
resident becomes eligible to take the boards may vary with the 
certifying body, that term is not defined further in the regulations. 
If the physician wishes to use this exemption, it is the physician's 
responsibility to ascertain the requirements of the body by which he or 
she wishes to become certified and to seek that certification as soon 
as he or she becomes eligible to do so.
5. Reestablishment of Qualifications
    Proposed Sec. 900.12(a)(1)(iv) provides a method for physicians to 
reestablish their qualifications as interpreting physicians in the 
event they do not maintain the continuing experience or education 
requirements. Proposed Sec. 900.12(a)(1)(iv)(A) requires the physician 
who fails to meet the continuing experience requirements to interpret 
at least 240 mammographic examinations under the direct supervision of 
a qualified interpreting physician within a period of 6 months 
immediately before reestablishing qualifications and resuming 
independent interpretation.
    Proposed Sec. 900.12(a)(1)(iv)(B) requires physicians who do not 
maintain the continuing education requirements to obtain a sufficient 
number of Category I CME credits in mammography to bring their total up 
to the required 15 credits in the previous 3 years. A physician who 
fails to maintain continuing experience or education requirements may 
not serve as an interpreting physician until he or she reestablishes 
those qualifications.

C. Radiologic Technologists

    FDA's interim regulations for radiologic technologists performing 
mammography sought to ensure that: (1) The technologists possessed 
adequate general qualifications for performing radiologic examinations; 
(2) the technologists possessed adequate specific qualifications for 
performing mammography examinations; and (3) the technologists 
maintained these qualifications over time. The proposed regulations are 
intended to achieve the same goals. They are primarily clarifications 
of the interim regulations with some added requirements to address 
concerns that developed as the interim regulations were implemented.
    The first clarification is in response to a number of comments 
received by FDA asking whether all of the radiologic technologists who 
perform mammography at the facility had to meet the requirements or if 
it would be sufficient if only some of them did. These questions may 
have been generated from experience with a previous voluntary system 
for accreditation.
    All radiologic technologists who perform mammography must meet the 
requirements. The plain language of the statute clearly states that 
personnel who perform mammography must meet the minimum training and 
experience requirements and either be licensed by a State or certified 
to perform radiological procedures by an organization designated by the 
Secretary of HHS (42 U.S.C. 263b(f)(1)(C)). The statute does not 
provide, nor does the legislative history indicate, that Congress 
intended any of the individuals who perform mammography to be exempt 
from minimum quality standards. Exempting some radiologic technologists 
from compliance with the personnel standards required under the act 
would increase, not diminish, the possibility that an incipient cancer 
might be misdiagnosed because of a poorly produced mammogram. FDA has 
revised Sec. 900.12(a)(2) to read ``All mammographic examinations shall 
be performed by radiologic technologists who meet the following general 
requirements, mammography requirements, and continuing education and 
experience requirements.'' Similar revisions were included in other 
paragraphs of Sec. 900.12(a) to clarify the requirement that all 
physicians and medical physicists must also meet the personnel 
qualifications specific to their areas of practice.
    Several comments expressed concern that the interim regulations 
would allow technologists with ``partial'' or ``special'' licenses to 
perform mammography. States that issue such licenses usually limit 
their holders to the performance of certain narrow types of 
examinations (e.g., extremities or dental x-rays) or particular medical 
practices (e.g., podiatry).
    The intent of the licensure requirement under the MQSA is to ensure 
that the radiologic technologist has a broad background in radiologic 
technology as a basis for his or her specific work in mammography. FDA 
does not believe that partial or special licenses demonstrate this 
necessary background. The provisions set forth in proposed 
Sec. 900.12(a)(2)(i)(A) require the State license to be a general 
license to perform radiologic procedures. As an alternative to 
obtaining such a State license, proposed Sec. 900.12(a)(2)(i)(B) would 
recognize a general certification by one of the bodies designated by 
FDA to certify radiologic technologists as adequate evidence that a 
technologist satisfies the general radiologic technology requirements.
    The license required by proposed Sec. 900.12(a)(2)(i)(A) must be a 
State license but need not be from the State in which the technologist 
currently practices, as some States do not have a licensing 
requirement. For States that do have their own licensing requirements, 
the technologists practicing in these States are responsible for 
meeting those licensing requirements as well as the requirements under 
the MQSA.
    One comment suggested that FDA amend the language of the interim 
regulations at Sec. 900.12(a)(2)(i)(B) to indicate that certification 
by an eligible body is an alternative that is available only when the 
State in which the radiologic technologist is practicing has no 
licensure procedures or requirements.
    Proposed Sec. 900.12(a)(2)(i) requires the technologist to become 
licensed or certified to perform general radiological procedures. The 
license may be obtained from a State under Sec. 900.12(a)(2)(i)(A) or 
the certificate can be obtained from an eligible certification body 
under Sec. 900.12(a)(2)(i)(B). If the technologist is certified by an 
eligible certifying body and practices in a State that has its own 
licensing requirement, the technologist must still become licensed 
under State law, unless otherwise exempted by the State.
    Although such individuals would be in compliance with Federal 
requirements under the MQSA, a technologist that is not licensed in 
accordance with the requirements of the

[[Page 14904]]
State in which he or she practices will be in violation of the State 
law.
    Several comments on the interim regulations stated that FDA should 
clarify the initial requirements that a radiological technologist must 
satisfy to demonstrate specific mammography training.
    After seeking and obtaining the advice of the NMQAAC, the agency 
has proposed more specific requirements for this training in 
Sec. 900.12(a)(2)(ii). Under the proposed regulation, training specific 
to mammography includes the performance of a minimum of 50 examinations 
under the direct instruction of a qualified individual. After the 
effective date of these regulations, only individuals meeting the 
requirements of Sec. 900.12(a)(2) for radiologic technologists will be 
considered qualified to provide this supervision.
    The NMQAAC has discussed the option of recognizing the American 
Registry of Radiologic Technologists' (ARRT) special certification in 
mammography as fulfilling, at least in part, the training requirement 
under Sec. 900.12(a)(2)(ii). At its February 1994 meeting, the NMQAAC 
advised against reducing the training required based on the ARRT 
special certification. However, at its subsequent meeting in May 1994, 
members reconsidered this possibility and discussed how much credit 
might reasonably be allocated for an ARRT special certification and for 
which aspects of the training requirements. Suggestions were made by 
some NMQAAC committee members that this special certificate be accepted 
in lieu of 20 of the required 40 contact hours, but that the 
certificate not be a substitute for any part of the required 
performance of 50 examinations under the direct supervision of a 
qualified radiologic technologist.
    After further consideration, FDA has decided not to propose 
recognition of the special certificate as a partial fulfillment of the 
training requirement. FDA does not want to incorporate into its 
regulations a training requirement that specifically relies on a 
particular certification program by a private group. If, in the 
agency's view, subsequent changes in the certification program 
diminished the certificate's value in assuring properly trained 
radiologic technologists, the agency might, nevertheless, be bound to 
continue to accept the certificate until the regulations could be 
amended through notice and comment rulemaking to remove the recognition 
of the certificate as a substitute for training. On the other hand, the 
agency believes that the training that is required to earn the 
certificate can fulfill part of the proposed training requirements, 
even if the program is not mentioned explicitly in the regulations. In 
fact, when evaluating technologists' training under the interim 
regulations, the agency has recognized the value of training hours 
required for AART special certification as well as training hours 
required by other programs. The agency intends to continue to do so, as 
long as it believes such recognition is warranted. Agency guidance on 
this subject is available for review. As mentioned earlier, guidance 
represents the agency's best thinking at the current time and does not 
bind either the facility or FDA.
    The NMQAAC did recommend that there be a requirement that all 
technologists have the equivalent of at least five continuing education 
units (CEU) of initial training in imaging examinees with breast 
implants. NMQAAC recognized that many technologists rarely conduct 
examinations of individuals with breast implants. However, the 
committee recommended that this training be required of all 
technologists so that all examinees with breast implants can use any 
certified facility with assurance that there will be technologists 
trained to perform these examinations.
    FDA agrees and has included this requirement in proposed 
Sec. 900.12(a)(2)(ii)(C).
    The interim regulations permit a technologist to have all of his or 
her training in mammography, both initial and continuing, related to 
one modality (e.g., film screen, xerography), even if the radiologic 
technologist uses other modalities to perform mammography. However, the 
agency and the NMQAAC believe that education and training should be 
required for each modality performed by the technologist. Proposed 
Sec. 900.12(a)(2)(ii)(B) and (a)(2)(iii)(B) would correct this 
shortcoming in the interim regulations by requiring both the initial 
training and the continuing education requirements to include training 
in each modality used by the technologist.
    Several comments on the interim regulations objected to the use of 
an undefined overall averaging period for the requirement that the 
radiologic technologist earn at least five CEU's per year in 
mammography.
    Although the use of an undefined time period has provided a 
flexibility that is advantageous under the interim regulations, FDA 
agrees that more specific requirements are desirable. Therefore, 
proposed Sec. 900.12(a)(2)(iii) requires that, on any given date, each 
technologist must have earned at least 15 CEU's in mammography in the 3 
years immediately preceding that date. To be fair to technologists who 
have just completed their initial training in mammography, proposed 
Sec. 900.12(a)(2)(iii) would not apply this requirement immediately. 
Technologists will have up to 3 years after completing their initial 
training to earn at least 15 CEU's related to mammography. After the 
end of the initial 3-year period, all technologists would have to be 
able to demonstrate, on any subsequent date, that they had earned at 
least 15 CEU's in mammography in the 3 previous years.
    Proposed Sec. 900.12(a)(2)(iii)(C) describes the actions that must 
be taken by technologists who fail to meet the continuing education 
requirement in order to reestablish their qualifications. Until these 
actions are taken, such technologists cannot perform mammographic 
examinations without supervision.
    In recognition of the fact that unused skills may deteriorate, 
proposed Sec. 900.12(a)(2)(iv) establishes a continuing experience 
requirement corresponding to the continuing experience requirement for 
interpreting physicians found in both the interim and proposed 
regulations. This requirement is based upon the advice of NMQAAC that 
performance of 100 or more mammography examinations a year represents a 
reasonable level of experience. Proposed Sec. 900.12(a)(2)(iv)(B) 
permits radiologic technologists who fail to meet this continuing 
requirement to reestablish their qualification through performance of 
50 examinations (a number suggested by NMQAAC) under the direct 
supervision of a qualified radiologic technologist before resuming 
independent performance of mammography examinations.
    One comment on the interim regulations questioned the use of 
October 1, 1996, for changing certain requirements for radiologic 
technologists while a date of October 27, 1997, was used for similar 
changes for medical physicists. The comment suggested that the dates 
should be the same.
    FDA notes that the MQSA established these dates and FDA cannot 
modify them. It is likely that the differences in these provisions is 
the result of congressional concern about the availability of medical 
physicists.
    Another comment suggested that a training and experience 
alternative to the licensure or certification requirement be made 
available to radiologic technologists similar to the alternative 
available to medical physicists.

[[Page 14905]]

    FDA disagrees, Congress specified the alternative route for medical 
physicists in the statute. The MQSA did not provide a similar 
alternative for technologists.

D. Medical Physicists

    Proposed requirements for medical physicists are set forth in 
Sec. 900.12(a)(3). FDA recognizes that the medical physicist plays a 
pivotal role in assuring the overall quality of mammography and, 
therefore, seeks to emphasize, in the proposed regulations, the need 
for uniform national minimum requirements for medical physicists 
working in mammography facilities.
    In developing the proposed qualifications for medical physicists, 
the agency has considered: (1) The requisite amount of prior knowledge 
and experience to evaluate mammography equipment; (2) the level of 
performance of individuals currently providing mammography physics 
support; (3) the concern over the supply of qualified medical 
physicists; and (4) the recommendations from members of the NMQAAC and 
comments from the Conference of Radiation Control Program Director's 
Task Force on Medical Physics Criteria. The issue of qualifications for 
medical physicists was discussed extensively at several NMQAAC 
meetings. Earlier draft regulations on this subject were shared with 
the NMQAAC and made available to the public.
    The MQSA provides two alternative pathways for medical physicists 
to demonstrate minimum qualifications after October 27, 1997. These 
alternative pathways, set forth in the statute and codified in proposed 
Sec. 900.12(a)(3)(i)(A), are: (1) State licensure or approval or (2) 
certification by a board approved by FDA. However, the NMQAAC expressed 
concern during the February 1994 meeting that not all States have 
adequate minimum qualification standards. Concern has also been 
expressed that some board certified physicists do not have adequate 
experience with mammography equipment. Therefore, FDA proposes to add 
additional requirements for all physicists, regardless of which initial 
route they follow to become qualified under the MQSA. After October 27, 
1997, or the effective date of the regulation, whichever is later, only 
those medical physicists who meet the initial additional education and 
experience requirements proposed in Sec. 900.12(a)(3)(i)(B) or 
(a)(3)(ii)(B) will be qualified to perform surveys under the MQSA.
    FDA believes that ongoing developments in imaging technology, 
including the development of new technologies, such as digital 
mammography, will require medical physicists to have increased 
understanding of science and technology in order to apply these 
scientific advances to the practice of mammography. Proposed 
Sec. 900.12(a)(3)(i)(B) addresses this need by requiring medical 
physicists who enter the field after October 27, 1997, to hold at least 
a master's degree in a physical science, including a minimum of 20 
semester credit hours or equivalent of college level physics, to have 
specialized training in conducting mammography surveys, and to have 
actual experience conducting surveys of at least 5 mammography 
facilities and a total of at least 10 mammography units. The experience 
in conducting surveys must be acquired under the direct supervision of 
a medical physicist who has fulfilled all of the requirements of 
Sec. 900.12(a)(3)(i) and (a)(3)(iii). This requirement is intended to 
ensure that medical physicists who serve as supervisors will have an 
adequate educational background to train new physicists in new imaging 
technologies.
    The advisory committee recommended that FDA require the 20 semester 
credit hours of physics be specific to imaging physics.
    FDA agrees that courses in imaging physics would be desirable. 
However, the agency does not have enough information about the number 
of imaging physics courses offered in different curricula to be certain 
that these courses would be available nationwide. Therefore, the agency 
has not proposed limiting the physics credit hours to imaging physics 
at this time. The agency is soliciting public comment on this issue.
    Although FDA believes that future changes in technology will 
require an enhancement of the educational qualifications of medical 
physicists, the agency also recognizes that currently there are a 
number of medical physicists with bachelor's degrees and substantial 
experience who are performing medical physics surveys of mammography 
facilities with care and competence. These physicists provide valuable 
physics support to facilities. The agency believes that it would be 
unjust to these physicists and potentially detrimental to the 
facilities that they serve to bar them from continuing to provide this 
physics support to mammography facilities in the absence of any 
evidence to show that the services that they currently offer are 
inadequate. Accordingly, proposed Sec. 900.12(a)(3)(ii) provides an 
opportunity for those individuals who are lawfully practicing medical 
physics under the interim regulations (21 CFR 900.12(a)(3)) to continue 
their practice after October 27, 1997.
    Proposed Sec. 900.12(a)(3)(ii) has been modified from the draft 
proposal discussed at the January 1995 meeting with the NMQAAC. During 
this meeting, the NMQAAC recommended that the opportunity to continue 
services as a mammography physicist because of prior experience should 
be open only to physicists with bachelor's degrees and 5 years of 
experience in conducting surveys of mammography facilities by October 
27, 1997.
    However, upon further consideration, FDA believes that the 
fundamental requirement of this alternative pathway is the quality and 
depth of the survey experience itself, and not the number of years it 
has taken the individual to acquire that experience. Therefore, 
proposed Sec. 900.12(a)(3)(ii) requires those physicists who intend to 
qualify because of prior experience to have performed surveys of at 
least 10 facilities and a total of at least 20 units by October 27, 
1997, or the effective date of these regulations, whichever date is 
later. This change has been made in order to give all medical 
physicists who are currently eligible to practice under the interim 
rules a reasonable opportunity to acquire the requisite experience 
before this alternative pathway closes.
    Proposed Sec. 900.12(a)(3)(ii) further requires that the bachelor's 
degree and specific training requirements be completed before any 
physics survey or unit evaluations may be counted toward satisfying the 
experience requirement under this provision. During a presentation at 
the January 1995 NMQAAC meeting, a representative of the medical 
physics community, speaking on behalf of the professional medical 
physicists who are members of the American College of Radiology, the 
American College of Medical Physics, and the North American Association 
of Physicists in Medicine, expressed the view that any mammography 
medical physics experience obtained prior to obtaining a basic 
understanding of fundamental principles through education is of little 
value. The NMQAAC also strongly recommended that the degree requirement 
must be a prerequisite to the experience requirement. The agency's 
proposal, therefore, establishes that the initial education and 
training qualifications must be met before any experience can be 
considered for purposes of satisfying the initial experience 
qualifications. The

[[Page 14906]]
agency is soliciting public comment on this requirement.
    Under proposed Sec. 900.12(a)(3)(iii), medical physicists will be 
required to maintain their education and experience qualifications, as 
are radiologic technologists and interpreting physicians.
    Proposed Sec. 900.12(3)(iv) establishes the requirements that 
medical physicists who fail to maintain their qualifications must meet 
to reestablish their eligibility to perform mammography facility 
surveys.
    At its February 1994 meeting, the NMQAAC members raised the concern 
that medical physicists who meet the qualifications requirement may 
nevertheless delegate the onsite survey work to less qualified 
personnel.
    FDA shares this concern and, therefore, is proposing in 
Sec. 900.12(e)(9), published elsewhere in this issue of the Federal 
Register, that the medical physicist who signs the facility survey 
report must be present at the facility during the survey and must meet 
the requirements of proposed Sec. 900.12(a)(3).
    Physicists in training may perform surveys in order to meet the 
experience requirement described in these standards, but they must do 
so under the direct supervision of a qualified medical physicist. 
``Direct supervision'' is defined in proposed Sec. 900.2(k)(2), also 
published elsewhere in this issue of the Federal Register, to mean: 
``During the performance of a mammography examination or survey of the 
facility's equipment and quality assurance program, the supervisor is 
present to observe and correct, as needed, the performance of the 
individual being supervised who is performing the examination or 
conducting the survey.''

E. Retention of Personnel Records

    Under the interim regulations, FDA is often asked how long records 
demonstrating personnel qualifications must be kept after an individual 
is no longer employed by the facility.
    Proposed Sec. 900.12(a)(4) requires that records be retained for 
all individuals employed in mammography by the facility from: (1) The 
date of the last inspection or (2) the effective date of the final 
regulations, whichever is later. Because inspections are required 
annually under the MQSA, records of individuals no longer employed by 
the facility typically would be retained less than a year after the 
individual's employment ends. The agency believes that this requirement 
will allow FDA adequately to assess whether personnel requirements are 
being met without putting an undue paperwork burden on the facility. 
Facilities should also become familiar with any State regulations that 
are applicable to personnel records because these State laws may 
require retaining the records for a longer period of time.

III. Environmental Impact

    The agency has determined under 21 CFR 25.24(e)(3) 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 together the impacts of this proposed rule and the 
proposed rules on accreditation bodies, general facility requirements, 
and quality standards for mammography equipment and quality assurance, 
published elsewhere in this issue of the Federal Register, under 
Executive Order 12866, the Regulatory Flexibility Act (Pub. L. 96-354), 
and under the Unfunded Mandates Reform Act. The analysis has addressed 
the proposed requirements of these four rules as one unit for purposes 
of determining their economic impact. The preamble to the proposed rule 
``Quality Mammography Standards; General Preamble and Proposed 
Alternative Approaches'', published elsewhere in this issue of the 
Federal Register, contains a brief summary of the cost and benefit 
determination and the Regulatory Impact Study that details the agency's 
calculation of these economic impacts and is available at the Dockets 
Management Branch (address above) for review. FDA recognized that these 
proposed regulations may have a disproportionate effect on small volume 
mammography facilities and is currently collecting additional 
information on the potential impact on this industry sector. The agency 
requests comments that will assist it in accounting for this impact.

V. Paperwork Reduction Act of 1995

    This proposed rule contains information collections which are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The title, 
description, and respondent description of the information collection 
and an estimate of the annual reporting and recordkeeping burden are 
contained in the proposed rule entitled ``Quality Mammography 
Standards; General Preamble and Proposed Alternative Approaches'' 
published elsewhere in this issue of the Federal Register.
    The agency has submitted a copy of this proposed rule to OMB for 
its review of these information collections. Other organizations and 
individuals desiring to submit comments regarding this burden estimate 
or any aspect of these information collection requirements, including 
suggestions for reducing the burden, should direct them to the Office 
of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 
725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Desk Officer 
for FDA. Written comments on the information collection should be 
submitted by May 3, 1996.

VI. Request for Comments

    Interested persons may, on or before July 2, 1996, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposed rule. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

VII. Reference

    The following reference has been placed on display in 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. ``Report on the Mammography Quality Standards Act of 1992,'' S. 
Rept. 102-448, October 1, 1992.

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, the 
Public Health Service 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 21 CFR part 900 continues to read as 
follows:

    Authority: Secs. 519, 537, and 704(e) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360i, 360nn, and 374(e)); sec. 354 of 
the Public Health Service Act (42 U.S.C. 263b).

    2. Section 900.12 is amended by revising paragraph (a) to read as 
follows:


Sec. 900.12  Quality standards.

* * * * *

[[Page 14907]]

    (a) Personnel. The following requirements apply to all personnel 
involved in any aspect of mammography, including the production, 
processing, and interpretation of mammograms and related quality 
assurance activities.
    (1) Interpreting physicians. All physicians interpreting mammograms 
shall meet the following qualifications:
    (i) Initial qualifications. Before beginning to interpret 
mammograms independently, the interpreting physician shall:
    (A) Be licensed to practice medicine in a State;
    (B)(1) Be certified in an appropriate specialty area by a body 
determined by FDA to have procedures and requirements adequate to 
ensure that physicians certified by the body are competent to interpret 
radiological procedures, including mammography; or
    (2) Have had at least 3 months of documented formal training in the 
interpretation of mammograms and in topics related to mammography. The 
training shall include instruction in radiation physics, including 
radiation physics specific to mammography, radiation effects, and 
radiation protection. The mammographic interpretation component shall 
be under the direct supervision of a physician who meets the 
requirements of paragraph (a)(1) of this section;
    (C) Have a minimum of 60 hours of documented medical education in 
mammography, which must include: Instruction in the interpretation of 
mammograms; at least 8 hours of Category I continuing medical education 
credits in each mammographic modality used in the interpreting 
physician's practice; and education in basic breast anatomy, pathology, 
and physiology; technical aspects of mammography, and quality assurance 
and quality control in mammography. At least 40 of these hours must be 
Category I and at least 15 of the Category I hours must have been 
acquired within the 3 years immediately prior to the date that the 
physician qualifies as an interpreting physician. Hours spent in 
residency specifically devoted to mammography will be considered as 
equivalent to Category I continuing medical education credits and will 
be accepted if documented in writing by the appropriate representative 
of the training institution; and
    (D) Have interpreted at least 240 mammographic examinations under 
the direct supervision of a qualified interpreting physician within the 
6-month period immediately prior to fulfilling the requirements of 
paragraph(a)(1)(i) of this section.
    (ii) Continuing experience and education. All interpreting 
physicians shall maintain their qualifications by meeting the following 
requirements:
    (A) At all times following the second anniversary date of 
completion of the requirements of paragraph (a)(1)(i) of this section, 
the interpreting physician shall have interpreted an average of at 
least 40 mammographic examinations a month during the previous 24 
months;
    (B) At all times following the third anniversary date of completion 
of the requirements of paragraph (a)(1)(i) of this section, the 
interpreting physician shall have taught or completed at least 15 
Category I continuing medical education credits in mammography in the 
previous 3 years. This training must include at least six Category I 
continuing medical education credits in each mammographic modality used 
by the interpreting physician in his or her practice; and
    (C) Before an interpreting physician may begin independently 
interpreting mammograms produced by a new mammographic modality, that 
is, a modality in which the physician has not previously been trained, 
the interpreting physician shall have at least 8 hours of training in 
the new modality.
    (iii) Exceptions. (A) Those physicians who previously qualified as 
interpreting physicians under FDA's interim regulations at 
Sec. 900.12(a)(1) are considered to have met the initial requirements 
of paragraph (a)(1)(i) of this section. They may continue to interpret 
mammograms provided they continue to meet the continuing experience and 
education requirements of paragraph (a)(1)(ii) of this section.
    (B) Physicians who have interpreted at least 240 mammographic 
examinations under the direct supervision of a qualified interpreting 
physician during the last 2 years of a diagnostic radiology residency 
and who become appropriately board certified at the first allowable 
time, as defined by an eligible certifying body, are otherwise exempt 
from paragraph (a)(1)(i)(D) of this section.
    (iv) Reestablishing qualifications. Interpreting physicians who 
fail to maintain the required continuing experience or continuing 
education requirements shall reestablish their qualifications before 
resuming the independent interpretation of mammograms, as follows:
    (A) Interpreting physicians who fail to meet the continuing 
experience requirements of paragraph (a)(1)(ii)(A) of this section 
shall interpret at least 240 mammographic examinations under the direct 
supervision of a qualified interpreting physician, within a period of 6 
months immediately prior to reestablishing their qualifications as an 
interpreting physician.
    (B) Interpreting physicians who fail to meet the continuing 
education requirements of paragraph (a)(1)(ii)(B) of this section shall 
obtain a sufficient number of additional Category I continuing medical 
education credits in mammography to bring their total up to the 
required 15 credits in the previous 3 years before resuming independent 
reading.
    (2) Radiologic technologists. All mammographic examinations shall 
be performed by radiologic technologists who meet the following general 
requirements, mammography requirements, and continuing education and 
experience requirements:
    (i) General requirements. (A) Be licensed to perform general 
radiographic procedures in a State; or
    (B) Have general certification from one of the bodies determined by 
FDA to have procedures and requirements adequate to ensure that 
radiologic technologists certified by the body are competent to perform 
radiologic examinations; and
    (ii) Mammography requirements. Have undergone 40 contact hours of 
documented training specific to mammography under the supervision of a 
qualified individual. A qualified individual is one that has met all 
the requirements of paragraph (a)(2) of this section. The 40 hours of 
documented training shall include:
    (A) Training in breast anatomy and physiology, positioning and 
compression, quality assurance/quality control techniques;
    (B) The performance of a minimum of 50 examinations under the 
direct supervision of a qualified individual; and
    (C) At least 5 hours of training in imaging examinees with breast 
implants and at least 8 hours of training in each imaging modality to 
be used by the technologist in performing mammography exams.
    (iii) Continuing education requirements. (A) At all times following 
the third anniversary date of completion of the requirements of 
paragraphs (a)(2)(i) and (a)(2)(ii) of this section or (insert 
effective date of the final regulation), whichever date is later, the 
radiologic technologist shall have taught or completed at least 15 
continuing education units related to mammography in the previous 3 
years.
    (B) At least six of these continuing education units shall be 
related to each

[[Page 14908]]
modality used by the technologist in mammography.
    (C) Requalification. Following any 3-year period in which a 
radiologic technologist fails to meet the continuing education 
requirements under paragraphs (a)(2)(iii)(A) through (a)(2)(iii)(B) of 
this section, that technologist shall obtain a sufficient number of 
continuing education units in mammography to bring the total up to at 
least 15 in the previous 3 years, at least 6 of which shall be related 
to each modality used by the technologist in mammography. The 
technologist may not resume performing unsupervised mammography 
examinations until the continuing education requirements are completed.
    (D) Before a radiologic technologist may begin independently 
performing mammographic examinations using a modality other than one of 
those for which the technologist received training under paragraph 
(a)(2)(ii)(C) of this section, the technologist shall have at least 8 
hours of continuing education units in the new modality.
    (iv) Continuing experience requirements. (A) In each 12-month 
period after completion of the requirements of paragraphs (a)(2)(i) and 
(a)(2)(ii) of this section or (effective date of the final rule), 
whichever date is later, the radiologic technologist shall perform a 
minimum of 100 mammography examinations.
    (B) Requalification. Following any 12-month period in which a 
radiologic technologist fails to perform at least 100 mammography 
examinations, that technologist shall perform a minimum of 50 
mammography examinations under the direct supervision of a qualified 
radiologic technologist, before resuming the performance of 
unsupervised mammography examinations.
    (3) Medical physicists. All medical physicists conducting surveys 
of mammography facilities and providing oversight of the facility 
quality assurance program under 42 U.S.C. 263b shall meet the 
following:
    (i) Initial qualifications. (A) Be State licensed or approved or 
have certification in an appropriate specialty area by one of the 
bodies determined by FDA to have procedures and requirements to ensure 
that medical physicists certified by the body are competent to perform 
physics surveys; and
    (B)(1) Have a master's degree or higher in a physical science from 
an accredited institution, including at least 20 semester hours or 
equivalent (e.g., 30 quarter hours) of college (graduate or 
undergraduate) level physics;
    (2) Have 20 contact hours of documented specialized training in 
conducting surveys of mammography facilities; and
    (3) Have the experience of conducting surveys of at least 5 
mammography facilities and a total of at least 10 mammography units. 
After the later date of October 27, 1997, or the effective date of 
these regulations, experience conducting surveys must be acquired under 
the direct supervision of a medical physicist who meets all the 
requirements of paragraphs (a)(3)(i) and (a)(3)(iii) of this section; 
or
    (ii) Alternative initial qualifications. (A) Have qualified as a 
medical physicist under the interim regulations at Sec. 900.12(a)(3) 
and maintained the active status of any qualifying licensure, approval, 
or certification required under the interim regulations; and
    (B) By October 27, 1997, or [Date 1 year after date of publication 
of the final rule] regulations, whichever is later, have:
    (1) A bachelor's degree or higher in a physical science from an 
accredited institution with no less than 10 semester hours or 
equivalent of college level physics,
    (2) Forty contact hours of documented specialized training in 
conducting surveys of mammography facilities and,
    (3) The experience of conducting surveys of at least 10 mammography 
facilities and a total of at least 20 mammography units. The training 
and experience requirements must be met after fulfilling the degree 
requirement.
    (iii) Continuing qualifications. (A) Continuing education. At all 
times after the third anniversary of completion of the initial 
requirements of paragraph (a)(3)(i) or (a)(3)(ii) of this section, the 
medical physicist shall have taught or completed at least 15 continuing 
education units in mammography over the preceding 3 years. This 
continuing education shall include training appropriate to each 
mammographic modality evaluated by the medical physicist during his or 
her surveys or oversight of quality assurance programs.
    (B) Continuing experience. At all times after the first anniversary 
of completion of the initial requirements of paragraph (a)(3)(i) or 
(a)(3)(ii) of this section, the medical physicist shall have surveyed 
at least three mammography facilities within the preceding 12 months.
    (C) Before a medical physicist may begin independently performing 
mammographic examinations using a new modality, that is, a modality 
other than one for which the physicist received training to qualify 
under paragraph (a)(3)(i) or (a)(3)(ii) of this section, the physicist 
must receive at least 8 hours of training in surveying units with the 
new modality.
    (iv) Reestablishing qualifications. Medical physicists who fail to 
maintain the required continuing qualifications of paragraph 
(a)(3)(iii) of this section may not perform the MQSA surveys without 
the supervision of a qualified medical physicist. Before independently 
surveying another facility, medical physicists must reestablish their 
qualifications, as follows:
    (A) Medical physicists who fail to meet the continuing educational 
requirements of paragraph (a)(3)(iii)(A) of this section shall obtain a 
sufficient number of continuing education units to bring their total 
units up to the required 15 in the previous 3 years.
    (B) Medical physicists who fail to meet the continuing experience 
requirement of paragraph (a)(3)(iii)(B) of this section shall complete 
a satisfactory survey of three mammography facilities under the direct 
supervision of a medical physicist who meets the qualifications of 
paragraphs (a)(3)(i) and (a)(3)(iii) of this section.
    (4) Retention of personnel records. Facilities shall maintain 
records to document the qualifications of all personnel employed by the 
facility in the production, processing, and interpretation of 
mammographic images. These records must be available for review by the 
MQSA inspectors and should not bediscarded until the next annual 
inspection has been completed and FDA has determined that the facility 
is in compliance with the MQSA personnel requirements.

* * * * *
    Dated: March 22, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-7832 Filed 3-29-96; 8:45 am]
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