SUPPORTING STATEMENT FOR

STATES AS CERTIFICATION AGENCIES

A. JUSTIFICATION

1\. [Circumstances Necessitating Information Collection]{.underline}

The Mammography Quality Standards Act (the MQSA) (Pub.L. 102-539) was
enacted on October 27, 1992. The purpose of the legislation was to
establish minimum national quality standards for mammography. The MQSA
required that to provide mammography services legally after October 1,
1994, all mammography facilities, except facilities of the Department of
Veterans Affairs, had to be accredited by an approved accreditation body
and certified by the Secretary of Health and Human Services (the
Secretary). The authority to approve accreditation bodies and to certify
facilities was delegated by the Secretary to FDA. The MQSA replaced a
patchwork of Federal, State, and private standards with uniform Federal
standards designed to ensure that all women nationwide receive adequate
quality mammography services. On October 9, 1998, the Mammography
Quality Standards Reauthorization Act (the MQSRA) (Pub. L. 105-248) was
enacted to extend the MQSA through fiscal year 2002.

Subsection (q) of the MQSA (42 U.S.C. 263b(q)) allows FDA to delegate to
qualified States, the authority for (1) issuing, renewing, suspending,
and revoking certificates, (2) conducting annual facility inspections
and follow-up inspections, and (3) implementing and enforcing the MQSA
quality standards for mammography facilities within the jurisdiction of
the qualified State.

To be approved, a State must (1) have enacted laws and issued
regulations equivalent to the MQSA standards and regulations, (2) have
the legal authority and qualified personnel to enforce those laws and
regulations, (3) devote adequate funds to the administration and
enforcement of those laws and regulations, and (4) provide FDA with
information and reports, as required.

FDA is to retain exclusive responsibility for (1) establishing quality
standards, (2) approving accreditation bodies, (3) approving and
withdrawing approval of State certification agencies, and (4)
maintaining oversight over State certification programs. Moreover, FDA
retains authority to suspend or revoke the certificate of facilities
within an approved State, and to take other administrative and judicial
actions against such facilities provided for in the MQSA.

The purpose of this rule is to establish the requirements to be met by
States as certification agencies (commonly known as and hereafter
referred to as States as Certifiers (SACs)) and the procedures for the
application, approval, and withdrawal of approval of SACs.

**21 CFR 900.21(b) - Reporting**

An applicant seeking FDA approval as a certification agency must submit
an application to FDA.

**21 CFR 900.21(c)(2) - Reporting**

If FDA notifies the applicant of any deficiencies in the application,
the applicant must correct the deficiencies or FDA may deny the
application.

**21 CFR 900.22 (a) - Recordkeeping**

A certification agency must establish and implement measures that FDA
has approved to reduce the possibility of conflict of interest or
facility bias on the part of individuals acting on the certification
agency's behalf.

**21 CFR 900.22(d)-(h) - Recordkeeping**

A certification agency must establish processes for the suspension and
revocation of certificates, appeals, additional mammography review from
accreditation bodies, and patient notification.

**21 CFR 900.22(i) - Reporting**

A certification agency shall obtain FDA authorization for any changes it
proposes to make in any standards that FDA has previously accepted.

**21 CFR 900.23 - Reporting**

FDA will perform an annual evaluation of each certification agency. The
certification agency must correct any major deficiencies noted by FDA or
FDA may withdraw approval of the certification agency.

# 21 CFR 900.24(a)

A certification agency that is required to correct major deficiencies
shall notify all facilities certified or seeking certification by it
within a time period and in a manner approved by FDA.

**21 CFR 900.24(a)(2) - Reporting**

A certification agency that has lost its approval shall notify
facilities certified or seeking certification by it as well as the
appropriate accreditation bodies with jurisdiction in the State that its
approval has been withdrawn. Such notification shall be made within a
time frame and in a manner approved by FDA.

**21 CFR 900.24(b) - Reporting**

If FDA notifies a certification agency that there are certain minor
deficiencies in its program, the certification agency must correct those
deficiencies or FDA may withdraw its approval.

**21 CFR 900.24(b)(1)**

If FDA places a certification agency on probationary status, the
certification agency shall notify all facilities certified or seeking
certification by it of its probationary status within a time and in a
manner approved by FDA

**21 CFR 900.24(b)(3) - Reporting**

If FDA determines that a certification agency that has been placed on
probationary status is not implementing corrective actions
satisfactorily or within the established schedule, FDA may withdraw
approval of the certification agency. The certification agency shall
notify all facilities certified or seeking certification by it, as well
as the appropriate accreditation bodies with jurisdiction in the State,
of its loss of FDA approval, within a time frame and in a manner
approved by FDA.

**21 CFR 900.25(a) - Reporting**

Opportunities to challenge final adverse actions taken by FDA regarding
approval of certification agencies or withdrawal of approval of
certification agencies shall be communicated through notices of
opportunity for informal hearings in accordance with 21 CFR Part 16.

**21 CFR 900.25(b) - Recordkeeping**

A facility that has been denied certification is entitled to an appeals
process from the certification agency. The appeals process shall be
specified in writing by the certification agency and shall have been
approved by FDA.

2\. [By Whom and for What Purpose the Information is to be
Used]{.underline}

FDA will use information from these information collection provisions to
review applications, approve or deny them, and withdraw approval, when
necessary.

3\. [Consideration of Information Technology]{.underline}

This program allows alternative appropriate technology. The Mammography
Program Reporting & Information system (MPRIS) has been operational for
approximately 3 years. Accreditation bodies send information to use
electronically through a dial up number. Inspection findings are
reported electronically on the inspector's laptop and then uploaded into
the system.

4\. [Efforts to Identify Duplication and Similar Information Already
Available]{.underline}

The FDA is the only Federal agency responsible for designating States as
certifying bodies under MQSA. Therefore, duplication with other data
sources is nonexistent.

5\. [Small Businesses]{.underline}

The burden of this information collection falls entirely upon States
that choose to apply to become certification agencies. There is no
effect upon small businesses.

6\. [Consequences of Less Frequent Information Collection and Technical
or Legal Obstacles.]{.underline}

States may voluntarily submit applications to become certifying agencies
at any time at their discretion. The only reporting burden with an
established timeframe is the annual review. FDA believes that an annual
review is necessary for its oversight duties to assure that State
certification agencies are adequately monitoring the quality of
mammography services in their state. All other reporting requirements in
the rule are on an *ad hoc* basis.

7\. [Consistency with the Guidelines in 5 CFR 1320.5]{.underline}

This regulation is consistent with principles in 5 CFR 1320.5.

8\. [Consultation Outside the Agency]{.underline}

In the proposed rule of March 30, 2000 (Tab B), FDA invited comments on
the proposed collection of information provisions of the SAC
regulations. FDA received two public comments addressing these
provisions. In addition, on May 3, 2000, the Office of Management and
Budget filed comment.

One comment recommended that the information collection burden be
lessened by reducing the amount of information required by
§900.21(b)(iii) in the application of a State applying to be a
certification agency. OMB likewise stated that FDA should consider ways
to reduce burdens to the States when submitting information for this
collection. The authors of the public comment suggested that the
requirements be reduced to:

\(A\) Requiring rules and regulations equivalent to subpart B of FDA's
part 900.

\(B\) Information on the education, experience and training requirements
of the applicant's professional staff.

\(C\) Statement of policies to avoid conflict of interest.

\(D\) Description of the applicant's mechanism for handling facility
inquiries and complaints.

\(E\) Any other information the FDA identifies as necessary to make a
determination on the approval of a State as a certifying agency.

The authors added that such a change would help correct what they
perceived to be an undue emphasis on paperwork in the proposed
regulations at the expense of adequate concern for the health and safety
of the public.

A second comment noted that additional mammography review and patient
notification are two processes for which FDA should not require written
policies and procedures. The comment also suggested that FDA allow State
agencies to attest to having adequate staffing, finances, and other
resources to implement and maintain a mammography certification program.

FDA again notes that the purpose of MQSA is to ensure that uniform
minimum national standards of quality are met for mammography. Comments
discussed in the preamble of the final rule expressed concerns about
whether this goal would continue to be achieved if multiple agencies
were allowed to carry out the SAC activities. If the goal is no longer
achieved when a State is authorized as a SAC, then the public health and
safety would suffer.

In responding to these comments in the final rule, FDA emphasized the
importance of its oversight activities in assuring that uniform minimum
national standards of quality continue to be met for mammography. The
agency further stressed that this oversight began with the review of the
original application for approval as a certification agency. FDA
believes that if there are problems that could hamper the State agency
from functioning effectively as a certification agency, to the extent
possible, those problems should be detected and corrected before, not
after, a State is authorized to be a SAC.

FDA has been conscious of the paperwork burden from the start and has
worked to reduce it for States applying to become certification agencies
under MQSA. At the present time, FDA allows attestation for several
areas of the SAC application including (1) availability of sufficient
funding and resources to carry out certification activities, (2)
maintenance of sufficient staffing levels as well as (3) several
inspection and compliance-related provisions. Experience with the MQSA
accreditation bodies has shown that initial attestation to adequate
staffing can be problematic. There have been occasions when the
accreditation body's attestation that it had sufficient staffing later
proved to be incorrect, perhaps due to insufficient prior analysis of
its needs. As a result, the accreditation body's efforts to effectively
carry out its functions were hampered for a period of time until it
could obtain adequate resources. Learning from its experience with
accreditation bodies, FDA is seeking assurance that a certification
agency has adequate staff in place at the time of approval, not several
months or a year later.

FDA also disagrees with the comment suggesting that FDA reduce the
information it required to the few categories listed. Under such an
approach, FDA would have to base a decision on whether to approve the
State agency as a certification agency without any information about the
agency's application review and decision making process for facility
certification. FDA would have no information on whether the State agency
had policies and procedures governing the notification of facilities of
certificate denials and expirations or for suspending or revoking a
facility certificate. The agency would have no information on how the
State agency planned to ensure that certificates are processed within a
reasonable time frame or whether the State had any time frame at all for
such actions. FDA would have no information on what process, if any, was
available for a facility to utilize in appealing adverse accreditation
decisions.

Furthermore, the agency would have to make its decision without any
information about the State agency's plans to inspect facilities
according to the statutory requirements. There would be no information
available on how the State agency planned to ensure that deficiencies
discovered during inspections were corrected. There would be no
information available on the State agency plans, if any, to apply such
enforcement actions as additional mammography review or patient
notification; issues that, as earlier comments showed, are of increasing
concern. On the support side, there would be no information available to
FDA to determine if the State's electronic data management and analysis
system was adequate. FDA's experience with accreditation bodies shows
that this is an area where there can be major problems that can hamper
the entire program. In short, if the application were reduced to the
extent recommended by the comments, FDA would have to make its decision
on the acceptability of the State agency as a certification agency based
upon inadequate information. Even the most basic information about how
the State proposes to conduct its major activities (certification,
inspection and compliance) would be missing completely.

FDA further notes that the estimated amount of time to provide the
information requested was minimal, a one time investment of 50 hours per
State. Even if the comments were accepted, the potential time saving is
small and certainly not sufficient to justify the potential risk to the
public should inadequate information lead the agency to approve an
applicant that could not carry out its responsibilities. The agency
concludes, after consideration of the possible options, that it has
achieved the best possible compromise between the desire to minimize the
information collection burden and the need to have adequate information
to carry out its public health responsibilities.

After considering ways to reduce the burden to the States, FDA has
concluded that, without the information included in the proposal, the
agency will be unable to make a valid assessment of the State agency's
capability to adequately perform the functions outlined above. If the
agency approves a certification agency that is unable to effectively
perform these functions, the public health and safety will be adversely
impacted within that State, perhaps significantly.

9\. [Payments or Gifts to Respondents]{.underline}

No payment or gifts shall be provided to respondents under this
regulation.

10\. [Confidentiality of Information]{.underline}

Information regarding States as certification agencies is available
under the Freedom of Information Act and 21 CFR Part 20. FDA expects
that it will receive little, if any, confidential information under this
information collection but any confidential information will be
protected in accordance with FOIA and Part 20.

11\. [Sensitive Questions]{.underline}

The information collection does not include questions concerning sex,
behavior, attitudes, religious beliefs, or private matters.

12\. [Estimates of Burden Hours and Explanation]{.underline}

The following is a summary of the estimated annual burden hours for
participation in the voluntary program:

Table 1a -- Requirements for States as Certifiers During Initial Year

Estimated Annual Reporting Burden ^1,2^

+----------+-------+----------+----------+---------+-------+-------+
| 21 CFR   | No.   | F        | Total    | Hours   | Total | Total |
|          | of    | requency |          |         |       |       |
| Section  |       |          | Annual   | Per     | Hours | Opera |
|          | R     | Per      |          |         |       | -ting |
|          | espon |          | R        | R       |       | and   |
|          |       | Response | esponses | esponse |       | M     |
|          | Dents |          |          |         |       | ainte |
|          |       |          |          |         |       | nance |
|          |       |          |          |         |       |       |
|          |       |          |          |         |       | Costs |
+----------+-------+----------+----------+---------+-------+-------+
| 9        | 13    | 1.0      | 13       | 50      | 650   | \$1   |
| 00.21(b) |       |          |          |         |       | 30.00 |
+----------+-------+----------+----------+---------+-------+-------+
| 9        | 13    | 1.0      | 13       | 25      | 325   | \$    |
| 00.21(c) |       |          |          |         |       | 65.00 |
| (2)      |       |          |          |         |       |       |
+----------+-------+----------+----------+---------+-------+-------+
| 9        | 2.0   | 0.1      | 0.2      | 5       | 1.0   | \     |
| 00.22(i) |       |          |          |         |       | $2.00 |
+----------+-------+----------+----------+---------+-------+-------+
| 900.23   | 2.0   | 1.0      | 2.0      | 20      | 40.0  | \$    |
|          |       |          |          |         |       | 20.00 |
+----------+-------+----------+----------+---------+-------+-------+
| 9        | 2.0   | 0.05     | 0.1      | 62      | 6.2   | \$    |
| 00.24(a) |       |          |          |         |       | 22.00 |
+----------+-------+----------+----------+---------+-------+-------+
| 900.     | 2.0   | 0.025    | 0.05     | 52      | 2.6   | \$    |
| 24(a)(2) |       |          |          |         |       | 10.00 |
+----------+-------+----------+----------+---------+-------+-------+
| 9        | 2.0   | 0.2      | 0.4      | 20      | 8.0   | \     |
| 00.24(b) |       |          |          |         |       | $4.00 |
+----------+-------+----------+----------+---------+-------+-------+
| 900.     | 2.0   | 0.05     | 0.1      | 52      | 5.2   | \$    |
| 24(b)(1) |       |          |          |         |       | 22.00 |
+----------+-------+----------+----------+---------+-------+-------+
| 900.     | 2.0   | 0.05     | 0.1      | 52      | 5.2   | \$    |
| 24(b)(3) |       |          |          |         |       | 20.00 |
+----------+-------+----------+----------+---------+-------+-------+
| 9        | 2.0   | 0.25     | 0.5      | 5       | 2.5   | \     |
| 00.25(a) |       |          |          |         |       | $5.00 |
+----------+-------+----------+----------+---------+-------+-------+
| # Total  |       |          |          |         | 1,    | \$3   |
|          |       |          |          |         | 045.7 | 00.00 |
+----------+-------+----------+----------+---------+-------+-------+

^1^ There are no capital costs associated with this collection of
information.

^2^ Due to a clerical error, the total reporting hours for 21 CFR
900.21(c)(2) and 900.22(i) that appeared in the proposed rule of March
30, 2000 (65Fr 16856) were incorrect. Table 1a of this document contains
the correct estimate.

Table 1b -- Requirements for States as Certifiers During Initial Year

Estimated Annual Recordkeeping Burden\*

+----------+--------+----------+---------+---------+------+----------+
| 21 CFR   | No. Of | F        | Total   | Hours   | T    | Total    |
|          |        | requency |         |         | otal |          |
| Section  | Record |          | Annual  | Per     |      | O        |
|          |        | Of       | Records |         | H    | perating |
|          | K      |          |         | Record  | ours |          |
|          | eepers | Record   |         |         |      | And      |
|          |        |          |         | Keeper  |      |          |
|          |        | Keeping  |         |         |      | Main-    |
|          |        |          |         |         |      |          |
|          |        |          |         |         |      | tenance  |
|          |        |          |         |         |      |          |
|          |        |          |         |         |      | Costs    |
+----------+--------+----------+---------+---------+------+----------+
| 9        | 2.0    | 1.0      | 2.0     | 1.0     | 2.0  | \$5.00   |
| 00.22(a) |        |          |         |         |      |          |
+----------+--------+----------+---------+---------+------+----------+
| 9        | 2.0    | 1.0      | 2.0     | 1.0     | 2.0  | \$5.00   |
| 00.22(d) |        |          |         |         |      |          |
|          |        |          |         |         |      |          |
| through  |        |          |         |         |      |          |
|          |        |          |         |         |      |          |
| \(h\)    |        |          |         |         |      |          |
+----------+--------+----------+---------+---------+------+----------+
| 9        | 2.0    | 1.0      | 2.0     | 1.0     | 2.0  | \$5.00   |
| 00.25(b) |        |          |         |         |      |          |
+----------+--------+----------+---------+---------+------+----------+
| **       |        |          |         |         | 6.0  | \$15.00  |
| Totals** |        |          |         |         |      |          |
+----------+--------+----------+---------+---------+------+----------+

\* There are no capital costs associated with this collection of
information.

Table 2a -Requirements for States as Certifiers

During Second and Later Years

Estimated Annual Reporting Burden\*

+----------+-------+----------+----------+---------+-------+-------+
| 21 CFR   | No.   | F        | Total    | Hours   | Total | Total |
|          | of    | requency |          |         |       |       |
| Section  |       |          | Annual   | Per     | Hours | Opera |
|          | R     | Per      |          |         |       | -ting |
|          | espon |          | R        | R       |       | and   |
|          |       | Response | esponses | esponse |       | M     |
|          | dents |          |          |         |       | ainte |
|          |       |          |          |         |       | nance |
|          |       |          |          |         |       |       |
|          |       |          |          |         |       | Costs |
+----------+-------+----------+----------+---------+-------+-------+
| 9        | 15.0  | 0.1      | 1.5      | 5       | 7.5   | \$    |
| 00.22(i) |       |          |          |         |       | 15.00 |
+----------+-------+----------+----------+---------+-------+-------+
| 900.23   | 15.0  | 1.0      | 15.0     | 20      | 300.0 | \$1   |
|          |       |          |          |         |       | 50.00 |
+----------+-------+----------+----------+---------+-------+-------+
| 9        | 15.0  | 0.05     | 0.75     | 62      | 46.5  | \$1   |
| 00.24(a) |       |          |          |         |       | 57.50 |
+----------+-------+----------+----------+---------+-------+-------+
| 900.     | 15.0  | 0.025    | 0.0375   | 52      | 19.5  | \$    |
| 24(a)(2) |       |          |          |         |       | 75.00 |
+----------+-------+----------+----------+---------+-------+-------+
| 9        | 15.0  | 0.2      | 3.0      | 20      | 60.0  | \$    |
| 00.24(b) |       |          |          |         |       | 30.00 |
+----------+-------+----------+----------+---------+-------+-------+
| 900.     | 15.0  | 0.05     | 0.75     | 52      | 39.0  | \$1   |
| 24(b)(1) |       |          |          |         |       | 50.00 |
+----------+-------+----------+----------+---------+-------+-------+
| 900.     | 15.0  | 0.05     | 0.75     | 52      | 39.0  | \$1   |
| 24(b)(3) |       |          |          |         |       | 50.00 |
+----------+-------+----------+----------+---------+-------+-------+
| 9        | 15.0  | 0.25     | 3.75     | 5       | 18.75 | \$    |
| 00.25(a) |       |          |          |         |       | 60.00 |
+----------+-------+----------+----------+---------+-------+-------+
| # Total  |       |          |          |         | 5     | \$7   |
|          |       |          |          |         | 30.25 | 87.50 |
+----------+-------+----------+----------+---------+-------+-------+

-   There are no capital costs associated with this collection of
    information.

Table 2b -- Requirements for States as Certifiers

During Second and Later Years

Estimated Annual Recordkeeping Burden\*

+----------+--------+----------+---------+---------+------+----------+
| 21 CFR   | No. Of | F        | Total   | Hours   | T    | Total    |
|          |        | requency |         |         | otal |          |
| Section  | Record |          | Annual  | Per     |      | O        |
|          |        | Of       | Records |         | H    | perating |
|          | K      |          |         | Record  | ours |          |
|          | eepers | Record   |         |         |      | And      |
|          |        |          |         | Keeper  |      |          |
|          |        | Keeping  |         |         |      | Main-    |
|          |        |          |         |         |      |          |
|          |        |          |         |         |      | tenance  |
|          |        |          |         |         |      |          |
|          |        |          |         |         |      | Costs    |
+----------+--------+----------+---------+---------+------+----------+
| 9        | 15.0   | 1.0      | 15.0    | 1.0     | 15.0 | \$37.50  |
| 00.22(a) |        |          |         |         |      |          |
+----------+--------+----------+---------+---------+------+----------+
| 9        | 15.0   | 1.0      | 15.0    | 1.0     | 15.0 | \$37.50  |
| 00.22(d) |        |          |         |         |      |          |
|          |        |          |         |         |      |          |
| through  |        |          |         |         |      |          |
|          |        |          |         |         |      |          |
| \(h\)    |        |          |         |         |      |          |
+----------+--------+----------+---------+---------+------+----------+
| 9        | 15.0   | 1.0      | 15.0    | 1.0     | 15.0 | \$37.50  |
| 00.25(b) |        |          |         |         |      |          |
+----------+--------+----------+---------+---------+------+----------+
| **       |        |          |         |         | 45.0 | \$112.50 |
| Totals** |        |          |         |         |      |          |
+----------+--------+----------+---------+---------+------+----------+

\* There are no capital costs associated with this collection of
information.

The additional reporting and record keeping burden will fall to the
State governments that choose to become certification agencies and not
the approximately 10,000 mammography facilities in the country (all of
whom are considered to be small entities). The mammography facilities
will continue to provide the same reports that they are presently
providing. The bulk of these reports will continue to go to the
accreditation bodies that are currently receiving them. The occasional
report (for example, if a facility appeals an adverse decision) that
presently goes to FDA will in SAC States go to the State. The facility
record keeping requirements also are unchanged.

The total additional reporting and record keeping burden on the States
from these regulations depends upon the States that choose to become
certification agencies. Since this choice is voluntary on the part of
the States, it is impossible to say with certainty how many will seek
these responsibilities. However, for purposes of estimation of the
possible maximum impact, FDA estimates that 15 states will become
certification agencies. This number included the two states currently
participating in the SAC Demonstration Project (Iowa and Illinois) and
13 additional states.

A further complication is that the regulations will lead to two types of
reporting and record keeping burden. The first is the initial, one time
burden resulting from applying for and obtaining approval as a state
certification agency. The second is the ongoing burden arising from FDA
fulfilling its oversight responsibilities. Because of the different
nature and time frames of these burdens, it is not possible to follow
the usual practice of stating the burden on a single set of tables. For
this reason, two sets of tables are provided. The first provides
estimates of the burden during the first year of the program. During
this year, it is assumed that the 13 new states will apply for and
obtain approval as certification agencies and so during that year they
will bear the initial one time burden associated with applying for and
receiving approval as a SAC State under §900.21.

Iowa and Illinois, having already received approval during the
Demonstration Project, will not have this burden. However, during the
first year, they will have the ongoing burdens of the evaluation process
(§900.23) and possibly that associated with obtaining FDA approval for
changes in previously approved standards (§900.22(i)) and correcting
deficiencies (§900.24-5). The 13 new states will not have been approved
in time to have to face this ongoing burden during the first years. The
second set of tables estimates the record keeping and reporting burden
in succeeding years when all 15 states have only the ongoing burden.

With respect to the ongoing burden, based upon the Agency's experience
with accreditation bodies, which must meet a similar requirement, the
agency estimated that a SAC state would seek approval for a change in
previously approved standards once every 10 years. The annual frequency
for reporting under §900.22(i) thus would be 0.1. Each SAC State will be
evaluated annually so the annual frequency for reporting under §900.23
will be one.

FDA estimated that each State would have to respond to major
deficiencies under §900.24(a) only once every 20 years and minor
deficiencies under §900.24(b) only once every 5 years. The annual
frequencies for reporting under those requirements were thus 0.05 and
0.2 respectively.

In addition, if the State certification agency is unable to correct its
major deficiencies to FDA's satisfaction and FDA withdraws its approval,
under §900.24(a)(2), it would have to notify the facilities that it has
certified. It was assumed that in fifty percent of the situations where
major deficiencies occurred, the State would be unable to correct them,
thus the frequency per response of having to notify facilities of
withdrawal of approval would be 0.05 x 0.50 = 0.025. The associated
hourly reporting burden per response would be the same as sending out
the original notification to the facilities of the State certification
agency's need for corrective action, that is, 52 hours.

In the cases where there are minor deficiencies, it was assumed that the
State will in most cases will make the necessary corrections but once
every 20 years (in other words, once out of every four times it has
minor deficiencies), the State would face possible withdrawal of
approval under §900.24(b)(2), so an annual of frequency of response of
0.05 was used there as well.

Finally, the agency assumed that once every four years (an annual
frequency of 0.25) each SAC State would seek an informal hearing under
§900.25(a) in responding to some adverse action against it.

FDA related the estimated recordkeeping burden to the maintenance of
standard operating procedures (SOPs) in several areas. FDA estimated
that each State would spend an hour per year maintaining each SOP. All
of these SOPs would be related to ongoing tasks under §900.22 through
§900.25.

The total estimated annual burden for the final MQSA regulations that
went into effect on April 28, 1999 was 184,510 hours. Adding a new
Subpart C to 21 CFR Part 900 Mammography to incorporate these proposed
regulations would lead to an estimated additional annual burden of
1,051.7 hours during the first year after the regulations were effective
and an estimated additional burden of 575.25 hours in each succeeding
year. Again, it should be remembered that the actual burden is dependent
upon how many States voluntarily choose to enter the SAC program. These
estimates are based up 15 States becoming SAC States. The estimates
would be reduced or increased if less than or more than 15 States join
the program.

13. [Annual Costs to Respondents]{.underline}

No capital costs are expected as a result of this proposal.

14. [Government Costs:]{.underline}

Costs to the government are limited to the time required to review
applications to become certification agencies. FDA has determined that
no additional costs or FTE's would be required to conduct such reviews.
States that become certification agencies will be removing a
commensurate burden from FDA.

15. [Changes in Burden]{.underline}

This is a new information collection.

16. [Statistical Reporting]{.underline}

No publication of information for statistical use is planned.

17\. [Exemption for Display of Effective Date]{.underline}

FDA is not seeking an exemption of display of effective date.

18\. [Exception to Certification Statement]{.underline}

There are no exceptions to the certification statement identified in
Item 19 of OMB Form 83-I.

List of Attachments:

Tab A - Final Rule: State Certification of Mammography Facilities.

Tab B - Proposed Rule: State Certification of Mammography Facilities