Federal Register / Vol. 63, No. 141 /Thursday, July 23, 1998 / Notices 39581

Supporting documents should be

included where they can present

information clearly and succinctly.

Applicants are encouraged to provide

information on their organizational

structure, staff, related experience, and

other information considered to be

relevant. Awarding offices use this and

other information to determine whether

the applicant has the capability and

resources necessary to carry out the

proposed project. It is important,

therefore, that this information be

included in the application. However,

in the narrative the applicant must

distinguish between resources directly

related to the proposed project from

those that will not be used in support

of the specific project for which funds

are requested.

The narrative should address the

specific requirements under Part II and

also provide information concerning

how the application meets the

evaluation criteria using the following

headings:

(a) Knowledge of TANF and Welfareto-Work Requirements;

(b) Approach and Project Design;

(c) Public—Private Partnerships;

(d) Staff Skills and Responsibilities;

(e) Budget Appropriateness;

(f) Empowerment Zone, Enterprise

Community and /or Brownfields.

The specific information to be

included under each of these headings

is described in section B of Part III—

Evaluation Criteria.

4. Assurances/Certifications

Applicants are required to file an SF

424B, Assurances—Non-Construction

Programs, and the Certification

Regarding Lobbying. Both must be

signed and returned with the

application. In addition, applicants

must certify their compliance with: (1)

Drug-Free Workplace Requirements; and

(2) Debarment and Other

Responsibilities. These certifications are

self-explanatory. Copies of these

assurances and certifications are

available from the ACF forms web site

mentioned previously. A duly

authorized representative of the

applicant organization must certify that

the applicant is in compliance with

these assurances and certifications. A

signature on the SF 424 indicates

compliance with Drug-Free Workplace

and Debarment notices and Public Law

103–227, Part C—Environmental

Tobacco Smoke, also known as the ProChildren Act of 1994.

D. Checklist for a Complete Application

The checklist below is for your use to

ensure that your application package

has been properly prepared.

—One original application, signed and

dated, plus two copies.

—Complete application length should

not exceed 100 pages.

—A complete application consists of the

following items in this order:

• Application for Federal Assistance

(SF 424);

• A completed SPOC certification

with the date of SPOC contact entered

in line 16, page 1 of the SF 424 if

applicable;

• Budget Information—Nonconstruction programs (SF 424A);

• Budget Justification for SF 424A

Section B—Budget Categories;

• Letter from the Internal Revenue

Service to prove nonprofit status, if

necessary;

• Copy of the applicant’s approved

indirect cost rate agreement, if

appropriate;

• Program Narrative Statement (See

Part III, Section C);

• Assurances—Non-construction

programs (SF 424B); and

• Certification Regarding Lobbying.

E. Submitting the Application

Each application package must

include an original and two copies of

the complete application. Each copy

should be secured with a binder clip or

similar devise. Please do not staple. All

pages of the narrative (including charts,

tables, maps, exhibits, etc.) must be

sequentially numbered. In order to

facilitate handling, please do not use

covers, binders, or tabs.

Applicant should include a selfaddressed, stamped acknowledgment

card. All applicants will be notified

automatically about the receipt of their

application.

Catalog of Federal Domestic Assistance

93.647.

Dated: July 17, 1998.

Diann Dawson,

Acting Director, Office of Family Assistance.

[FR Doc. 98–19609 Filed 7–22–98; 8:45 am]

BILLING CODE 4184–01–P

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.

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
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