39582 Federal Register / Vol. 63, No. 141 /Thursday, July 23, 1998 / Notices

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

No. of Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Screener: 648 1 648 0.033 21

Interview: 648 1 648 .25 162

Total 183

1There 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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0570]

BASF Corp.; Filing of Food Additive

Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that BASF Corp. has filed a petition

proposing that the food additive

regulations be amended to provide for
Federal Register / Vol. 63, No. 141 /Thursday, July 23, 1998 / Notices 39583

the safe use of chromium antimony

titanium buff rutile (C.I. Pigment Brown

24) as a colorant for polymers intended

for use in contact with food.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 8B4608) has been filed by

BASF Corp., 3000 Continental Dr.

North, Mt. Olive, NJ 07828–1234. The

petition proposes to amend the food

additive regulations to provide for the

safe use of chromium antimony

titanium buff rutile (C.I. Pigment Brown

24) as a colorant for polymers intended

for use in contact with food.

The agency has determined under 21

CFR 25.32(i) that this action is of the

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.

Dated: July 6, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–19562 Filed 7–22–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0569]

Ticona; Filing of Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Ticona has filed a petition

proposing that the food additive

regulations be amended to provide for

the safe use of ethylene-norbornene

copolymers as articles or components of

articles in contact with dry food.

DATES: Written comments on the

petitioner’s environmental assessment

by August 24, 1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Julius Smith, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3091.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 8B4597) has been filed by

Ticona, c/o Keller and Heckman, 1001

G St. NW., suite 500 West, Washington,

DC 20001. The petition proposes to

amend the food additive regulations in

§ 177.1520 Olefin polymers (21 CFR

177.1520) to provide for the safe use of

ethylene-norbornene copolymers as

articles or components of articles in

contact with dry foods.

The potential environmental impact

of this action is being reviewed. To

encourage public participation

consistent with regulations issued under

the National Environmental Policy Act

(40 CFR 1501.4(b)), the agency is

placing the environmental assessment

submitted with the petition that is the

subject of this notice on public display

at the Dockets Management Branch

(address above) for public review and

comment. Interested persons may, on or

before August 24, 1998, submit to the

Dockets Management Branch (address

above) written comments. 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.

FDA will also place on public display

any amendments to, or comments on,

the petitioner’s environmental

assessment without further

announcement in the Federal Register.

If, based on its review, the agency finds

that an environmental impact statement

is not required and this petition results

in a regulation, the notice of availability

of the agency’s finding of no significant

impact and the evidence supporting that

finding will be published with the

regulation in the Federal Register in

accordance with 21 CFR 25.40(c).

Dated: July 6, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–19561 Filed 7–22–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–64, 64.21, 64.21U, 64.21P, 64.21UP,

64EC, 64.21E, 64.9P, 64.10P, 64.11A, 64.9d]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding the burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) the

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Revision of a currently

approved collection;

Title of Information Collection:

Quarterly Medicaid Statement of

Expenditures for the Medical Assistance

Program.

Form Nos.: HCFA–64, 64.21, 64.21U,

64.21P, 64.21UP, 64EC, 64.21E, 64.9,

64.10, 64.10P, 64.11a, 64.9d;

Use: These new forms are revisions of

the currently approved collection report

Form HCFA–64. These forms will be

used by State Medicaid agencies to

report their actual CHIP-related

Medicaid expenditures and the numbers

of CHIP-related children, and other

children being served in the Medicaid

program, to the Health Care Financing

Administration (HCFA). The forms will

be used by the HCFA to ensure that the

appropriate level of Federal payments

for the State’s CHIP-related Medicaid

program expenditures are made in

accordance with the CHIP and related

Medicaid provisions of the BBA of 1997,

and to track, monitor, and evaluate the

numbers of CHIP-related children and

other individuals being served by the

Medicaid program.

Note: at this time Forms HCFA–

64.21E and HCFA–64EC of this package

are for States to report the numbers of

CHIP-related children and other