Agency Information Collection Activities; Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N-0147]

Agency Information Collection Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the

proposed collection of information listed below has been submitted to

the Office of Management and Budget (OMB) for review and clearance

under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by

August 24, 1998.

ADDRESSES: Submit written comments on the collection of information to

the Office of Information and Regulatory Affairs, OMB, New Executive

Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:

Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Margaret R. Schlosburg, Office of

Information Resources Management (HFA-250), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA

(44 U.S.C. 3507), FDA has submitted the following proposed collection

of information to OMB for review and clearance.

Access to Mammography Services Survey--New

Under the Mammography Quality Standards Act (MQSA) (42 U.S.C.

2636), FDA is authorized to develop regulations, inspect facilities,

and ensure compliance with standards established to assure quality

mammography services for all women. In the legislative history of MQSA,

Congress expressed the need to balance quality improvements with impact

on access to mammography services. The Government Accounting Office

(GAO) has recently done an assessment and concluded that access has

been minimally affected. However, new regulations will become effective

April 28, 1999.

The Mammography Facility Survey (the survey) will provide FDA

important information about the impact of specific aspects of the MQSA

program on access to mammography services. The survey will provide

facility closure rates both pre- and post-implementation of the final

regulations. Furthermore, the survey will determine reasons for

facility closures, including those related to specific MQSA regulations

and those that are attributable to general operational challenges.

Finally, the survey will also gather information from operating

facilities to determine the impact of MQSA regulations on facilities

that continue to provide mammography services. Participation will be

voluntary. A total of 460 facilities (240 annually) that have

[[Page 39582]]

ceased to provide mammography services will be given the opportunity to

take part in a 15 minute telephone survey. These facilities will be

matched by zip code (and by facility type and size, within zip code) to

1,840 open mammography centers (960 annually) to provide up to four

controls for each closed facility . Each of the open facilities will

also be offered the opportunity to participate in the study up until we

have two matched control completed interviews. The survey will collect

demographic information from each survey respondent and then proceed to

ask questions that address the perceived impact on the facility's

ability to provide mammography services of factors related to specific

MQSA regulations, as well as factors not directly associated with MQSA

requirements. Additional descriptive information about the facilities

will be abstracted from various FDA databases in order to enhance the

level of detail that is known about each respondent.

In the Federal Register of March 18, 1998 (63 FR 13256), the

agency requested comments on the proposed collection of information

using the Mammography Facility Survey. FDA received one response to the

docket, which was generally supportive of the proposed survey. This

comment, however, recommended that the survey address two issues, which

are described in the next two paragraphs along with FDA's responses.

The first issue stated that some facilities apply for

accreditation/certification but are denied several times. Ultimately

they withdraw from the MQSA process, and reapply using a different name

or address. The concern mentioned in the comment is that such

facilities are ``inflating the actual number of facilities that have

been negatively impacted by the cost and time involved in lawfully

performing quality mammography services.'' FDA's response to this

comment is twofold. First, the Mammography Facility Survey is not

intended to estimate the rate at which facilities are closing, so the

issue of considering such facilities as being closed when they are

planning to reapply (and, thus, overestimating the rate of facility

closure) is not relevant to this study. This study is intended to

examine factors that distinguish closed from open facilities. For this

purpose, a facility such as those described in the comment can

legitimately be considered closed at the time of the survey. Second,

the survey does collect information about each facility's

accreditation/certification history, and the length of time the

facility has been closed, its current status, and its plans for

reapplying for accreditation in the near future.

The second issue stated that many time-consuming activities

included in the inspection phase of the MQSA process could be performed

during the accreditation/certification phase and, thus, ``reduce the

time and cost of the entire process to the mammography facility,'' as

well as ``achieve a more uniform application of the requirements and

minimize the impact to patient care/access.'' The comment suggested

that the survey should explore the effects of reviewing both staff's

professional qualifications and the medical physicist's annual survey

of mammography machines during the accreditation/certification process.

FDA views this comment as pertaining more to FDA policy regarding the

timing of the two particular reviews mentioned in the comment. FDA's

policy has been carefully developed to require both staff professional

qualifications and a medical physicist's survey of mammography machines

on a yearly basis (rather than on a triennial basis). Any change in

this policy is not the focus of the current survey, although this study

will gather information that might suggest whether the policy should be

re-examined. Any facility that responds that the inspection process or

the accreditation/certification process was a ``major problem'' in

terms of money and/or time is asked to describe the nature of the

problem. Thus, the responses to these survey items will indicate

whether various aspects of the inspection and/or accreditation/

certification processes are very burdensome to facilities. FDA

estimates the burden of this collection of information as follows:

Table 1.-- Estimated Annual Reporting Burden1

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Annual

No. of Respondents Frequency per Total Annual Hours per Total Hours

Response Responses Response

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Screener: 648 1 648 0.033 21

Interview: 648 1 648 .25 162

Total 183

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\1\ There are no capital costs or operating and maintenance costs associated with this collection of

information.

The number of facilities to be included in the study have increased

from the estimate in FDA's previous notice seeking comment on this

collection of information (63 FR 13256, March 18, 1998). This is

because the numbers in the previous estimate were too low and

represented a study period of only 6 months, which is not enough time

to obtain interviews both before and after the final implementation of

the MQSA regulations on April 28, 1999. The change in the matching

factors is an outcome of the pilot study that revealed the large range

in types of mammography facilities responding to the survey.

Dated: July 13, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-19635 Filed 7-22-98; 8:45 am]

BILLING CODE 4160-01-F