Federal Register / Vol. 63, No. 114 / Monday, June 15, 1998 / Notices 32663

indicated. The application also will be

available for inspection at the offices of

the Board of Governors. Interested

persons may express their views in

writing on the standards enumerated in

the BHC Act (12 U.S.C. 1842(c)). If the

proposal also involves the acquisition of

a nonbanking company, the review also

includes whether the acquisition of the

nonbanking company complies with the

standards in section 4 of the BHC Act.

Unless otherwise noted, nonbanking

activities will be conducted throughout

the United States.

Unless otherwise noted, comments

regarding each of these applications

must be received at the Reserve Bank

indicated or the offices of the Board of

Governors not later than July 10, 1998.

A. Federal Reserve Bank of

Richmond (A. Linwood Gill III,

Assistant Vice President) 701 East Byrd

Street, Richmond, Virginia 23261-4528:

1. First Region Bancshares, Inc.,

Richlands, Virginia; to become a bank

holding company by acquiring 100

percent of the voting shares of First

Sentinel Bank, Richlands, Virginia.

B. Federal Reserve Bank of St. Louis

(Randall C. Sumner, Vice President) 411

Locust Street, St. Louis, Missouri 63102-

2034:

1. Mercantile Bancorporation Inc., St.

Louis, Missouri, and its wholly owned

subsidiary, Ameribanc, Inc., St. Louis,

Missouri; to acquire and thereby merge

with Financial Services Corporation of

the Midwest, Rock Island, Illinois, and

thereby indirectly acquire The Rock

Island Bank, N.A., Bettendorf, Iowa.

C. Federal Reserve Bank of Kansas

City (D. Michael Manies, Assistant Vice

President) 925 Grand Avenue, Kansas

City, Missouri 64198-0001:

1. Financial Bancshares, Inc., Holton,

Kansas; to acquire 18.18 percent of the

voting shares of Arizona Bancshares,

Inc., Flagstaff, Arizona, and thereby

indirectly acquire First State Bank,

Flagstaff, Arizona, a de novo bank.

Comments regarding this application

must be received not later than July 6,

1998.

2. Gold Banc Corporation, Inc.,

Leawood, Kansas; to acquire 100

percent of the voting shares of

Northwest Bancshares, Inc., Colby,

Kansas, and thereby indirectly acquire

Peoples State Bank, Colby, Kansas.

Board of Governors of the Federal Reserve

System, June 10, 1998.

Robert deV. Frierson,

Associate Secretary of the Board.

[FR Doc. 98–15841 Filed 6–12–98; 8:45 am]

BILLING CODE 6210–01–F

FEDERAL RESERVE SYSTEM

Notice of Proposals to Engage in

Permissible Nonbanking Activities or

to Acquire Companies that are

Engaged in Permissible Nonbanking

Activities

The companies listed in this notice

have given notice under section 4 of the

Bank Holding Company Act (12 U.S.C.

1843) (BHC Act) and Regulation Y, (12

CFR Part 225) to engage de novo, or to

acquire or control voting securities or

assets of a company, including the

companies listed below, that engages

either directly or through a subsidiary or

other company, in a nonbanking activity

that is listed in § 225.28 of Regulation

Y (12 CFR 225.28) or that the Board has

determined by Order to be closely

related to banking and permissible for

bank holding companies. Unless

otherwise noted, these activities will be

conducted throughout the United States.

Each notice is available for inspection

at the Federal Reserve Bank indicated.

The notice also will be available for

inspection at the offices of the Board of

Governors. Interested persons may

express their views in writing on the

question whether the proposal complies

with the standards of section 4 of the

BHC Act.

Unless otherwise noted, comments

regarding the applications must be

received at the Reserve Bank indicated

or the offices of the Board of Governors

not later than June 30, 1998.

A. Federal Reserve Bank of St. Louis

(Randall C. Sumner, Vice President) 411

Locust Street, St. Louis, Missouri 63102-

2034:

1. The Peoples Bancshares, Inc.,

Sardis, Tennessee; to engage in the

leasing of personal or real property,

pursuant to § 225.28(b)(3) of Regulation

Y.

Board of Governors of the Federal Reserve

System, June 10, 1998.

Robert deV. Frierson,

Associate Secretary of the Board.

[FR Doc. 98–15842 Filed 6–12–98; 8:45 am]

BILLING CODE 6210–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Announcement Number 98088]

Notice of Availability of Funds for

Fiscal Year 1998; Resource Center for

Unintentional Injury Prevention Among

Older Americans

Introduction

The Centers for Disease Control and

Prevention (CDC), announces the

availability of fiscal year (FY) 1998

funds for a cooperative agreement to

establish a Resource Center for

Unintentional Injury Prevention Among

Older Americans.

CDC is committed to achieving the

health promotion and disease

prevention objectives of ‘‘Healthy

People 2000,’’ a national activity to

reduce morbidity and mortality and

improve the quality of life. This

announcement is related to the priority

area of Unintentional Injuries. (For

ordering copies of ‘‘Healthy People

2000’’ and ‘‘Major Causes of

Unintentional Injuries Among Older

Persons’’ [1996], see the Section WHERE

TO OBTAIN ADDITIONAL

INFORMATION.)

Authority

This program is authorized under

sections 301, 317, and 391–394 [42

U.S.C. 241, 247b, and 280b–280b–3] of

the Public Health Service Act as

amended.

Smoke-Free Workplace

CDC strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the non-use

of all tobacco products, and Public Law

103–227, the Pro-Children Act of 1994,

prohibits smoking in certain facilities

that receive Federal funds in which

education, library, day care, health care,

and early childhood development

services are provided to children.

Eligible Applicants

Applications may be submitted by

public and private non-profit

organizations and by governments and

their agencies. Thus, universities,

colleges, research institutions, hospitals,

other public and private nonprofit

organizations, State and local

governments or their bona fide agents,

and federally recognized Indian tribal

governments, Indian tribes, or Indian

tribal organizations are eligible to apply.

Note: Effective January 1, 1996, Public Law

104–65 states that an organization described
32664 Federal Register / Vol. 63, No. 114 / Monday, June 15, 1998 / Notices

in section 501(c)(4) of the Internal Revenue

Code of 1986 which engages in lobbying

activities shall not be eligible to receive

Federal funds constituting an award, grant

(cooperative agreement), contract, loan, or

any other form.

Availability of Funds

Approximately $194,000 is available

in FY 1998 to fund one award. It is

expected that the award will begin on or

about September 30, 1998, and will be

made for a 12-month budget period

within a project period of up to 3 years.

Funding estimates may vary and are

subject to change.

A continuation award within the

project period will be made on the basis

of satisfactory progress and the

availability of funds.

Restrictions on Lobbying

Applicants should be aware of

restrictions on the use of HHS funds for

lobbying of Federal or State legislative

bodies. Under the provisions of 31

U.S.C. Section 1352 (which has been in

effect since December 23, 1989),

recipients (and their sub-tier

contractors) are prohibited from using

appropriated Federal funds (other than

profits from a Federal contract) for

lobbying Congress or any Federal

agency in connection with the award of

a particular contract, grant, cooperative

agreement, or loan. This includes

grants/cooperative agreements that, in

whole or in part, involve conferences for

which Federal funds cannot be used

directly or indirectly to encourage

participants to lobby or to instruct

participants on how to lobby.

In addition, the FY 1998 Department

of Labor, Health and Human Services,

and Education, and Related Agencies

Appropriations Act (Public Law 105–78)

states in Section 503 (a) and (b) that no

part of any appropriation contained in

this Act shall be used, other than for

normal and recognized executivelegislative relationships, for publicity or

propaganda purposes, for the

preparation, distribution, or use of any

kit, pamphlet, booklet, publication,

radio, television, or video presentation

designed to support or defeat legislation

pending before the Congress or any

State legislature, except in presentation

to the Congress itself or any State

legislature. No part of any appropriation

contained in this Act shall be used to

pay the salary or expenses of any grant

or contract recipient, or agent acting for

such recipient, related to any activity

designed to influence legislation or

appropriations pending before the

Congress or any State legislature.

Prohibition on Use of CDC Funds for

Certain Gun Control Activities

The Departments of Labor, Health and

Human Services, and Education, and

Related Agencies Appropriations Act,

1998, specifies that: ‘‘None of the funds

made available for injury prevention

and control at the Centers for Disease

Control and Prevention may be used to

advocate or promote gun control.’’

Anti-Lobbying Act requirements

prohibit lobbying Congress with

appropriated Federal monies.

Specifically, this Act prohibits the use

of Federal funds for direct or indirect

communications intended or designed

to influence a member of Congress with

regard to specific Federal legislation.

This prohibition includes the funding

and assistance of public grassroots

campaigns intended or designed to

influence members of Congress with

regard to specific legislation or

appropriation by Congress.

In addition to the restrictions in the

Anti-Lobbying Act, CDC interprets the

language in the CDC’s 1998

Appropriations Act to mean that CDC’s

funds may not be spent on political

action or other activities designed to

affect the passage of specific Federal,

State, or local legislation intended to

restrict or control the purchase or use of

firearms.

Background

The elderly population is increasing

more rapidly than other age groups, and

its share of the total U.S. population is

rising rapidly. Among people 65 years

and older, unintentional injuries are the

seventh leading cause of death; there

were over 29,000 deaths from

unintentional injuries in 1995. The

death rate from injuries increases

exponentially with age. Among people

aged 65 years and older; the death rate

is higher among men than among

women, and higher among whites than

among other races. The major causes of

unintentional injury mortality are falls,

motor vehicle crashes, drowning, fires

and burns, and poisonings.

Falls are the second leading cause of

injury deaths among people 65–84 and

the leading cause for people aged 85

years and older. In 1995, almost 7,900

people over age 65 years died as a result

of falls. Falls are the most common

cause of injuries and hospital

admissions for trauma among the

elderly. Falls account for 87 percent of

all fractures among people aged 65 years

or older and are the second leading

cause of spinal cord and brain injury.

The most serious fall-related injury is

hip fracture. Approximately 240,000 hip

fractures occur each year in the United

States; 75 percent to 80 percent of all

hip fractures are sustained by women.

The impact of these injuries on the

quality of life is enormous. Half of all

elderly adults hospitalized for hip

fracture cannot return home or live

independently after the fracture. The

annual cost for treating these injuries

was over 3 billion dollars in 1986.

Since most fractures are the result of

falls, understanding factors which

contribute to falling is essential in order

to design effective intervention

strategies. For people aged 65 years or

older, 60 percent of fatal falls occur in

the home, 30 percent occur in public

places, and 10 percent occur in health

care institutions. Factors that contribute

to falls include dementia, visual

impairment, neurologic and

musculoskeletal disabilities,

psychoactive medications, and

difficulties in gait and balance.

Environmental hazards such as slippery

surfaces, uneven floors, poor lighting,

loose rugs, unstable furniture, and

objects on floors may also play a role.

People 65 years and older represent

13 percent of the population and about

17 percent of all motor vehicle-related

deaths. In 1995, 6,991 people 65 years

and older died in crashes—79 percent as

passenger vehicle occupants, and 18

percent as pedestrians. This represents

a 25 percent increase from 1985. Per

mile driven, elderly drivers have higher

fatal crash rates than drivers in all other

age groups except teenagers. One reason

elderly people have higher death rates

than younger people from motor vehicle

crashes is that they are more susceptible

to medical complications following

injuries. This means they are more

likely to die from their injuries.

Purpose

The purpose of this announcement is

to establish a Resource Center for the

Prevention of Unintentional Injuries

Among Older Americans (people ages

65 and older) and to disseminate this

information. The Resource Center will

provide this information to health care

professionals, caretakers, and other

individuals concerned about reducing

injuries among Older Americans.

Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under A. (Recipient Activities), and

CDC will be responsible for the

activities listed under B. (CDC

Activities).

A. Recipient Activities

In Year one:
Federal Register / Vol. 63, No. 114 / Monday, June 15, 1998 / Notices 32665

1. Establish links and/or collaborative

relationships with organizations which

have demonstrated resources,

information, and/or programs related to

injuries among older adults.

2. Identify the target audiences which

will benefit from access to injury

prevention program materials. For

example, these may include public or

private organizations, health care

professionals, caretakers, and others

concerned about reducing injuries

among seniors.

3. Conduct a needs assessment to

determine the types and forms of

information needed by the various target

audiences. This assessment should

guide the decisions about what types

and in what forms data are to be made

available.

4. Compile unintentional injury

prevention program information and

resource materials related to people 65

years and older from these collaborating

organizations and establish a repository

for these materials.

5. Develop and test a system that

incorporates a variety of methods by

which the identified target audiences

can access/obtain this data.

6. Develop training materials and

distribution plan that will ensure

participation of the target audiences.

7. Conduct process and outcome

evaluation of year 01 activities.

In Years two and three: (Continue

work on 1–7).

8. Implement the dissemination/

distribution plan developed during Year

01.

9. Conduct process and outcome

evaluation of Year 02 and 03 activities.

B. CDC Activities

1. Provide technical advise and

consultation on all aspects of recipient

activities.

2. Provide technical assistance

regarding up-to-date scientific resources

regarding injuries and injury prevention

among people 65 years and older.

Technical Reporting Requirements

An original and two copies of a semiannual progress report must be

submitted 30 days after the end of each

six month period. The progress reports

must include the following for each

function or activity involved: (1) a

comparison of actual accomplishments

to the objectives established for the

period; (2) the reasons for slippage if

established objectives are not met; and

(3) other pertinent information

including, when appropriate, analysis

and explanation of unexpectedly high

costs for performance. An original and

two copies of a Financial Status Report

(FSR) is required no later than 90 days

after the end of the budget period. A

final progress report and FSR are due no

later than 90 days after the end of the

project period. All reports are submitted

to the Grants Management Branch, CDC.

Application Content

Each application should be limited to

30 pages, excluding the budget/budget

justification page(s) and attachments

(i.e., letters of commitment, data

collection forms, resumes, etc.). All

material must be typewritten, doublespaced, with type no smaller than 10

characters per inch (CPI) or 12 point

type Times Roman or Courier 10 point,

on 8.5′′ x 11′′ paper, with at least a 1′′

margin. Number each page clearly and

provide a complete index.

A. The application must include:

1. Abstract: A one page abstract and

summary of the proposed effort.

2. Background and Need: Provide

background and documentation of the

need for and benefits of maintaining a

national repository and actively

disseminating information on injury

prevention among older Americans, and

keeping the subject in the public’s

attention.

3. Goals and Objectives: Overall

goal(s) which indicate where the

applicant desires to be at the end of the

project period and specific time-framed,

measurable and achievable program

objectives for each goal(s).

4. Description of Activities: A detailed

description (i.e., who, what, how, and

when) of specific activities to be

undertaken to achieve each of the

program objectives during the project

period. A time-frame should be

included which indicates when each

activity will occur and who will be

responsible for each activity. Include an

organizational chart identifying

placement of the program within its

relevant organizational system (e.g., the

university system).

5. Methodology: A detailed

description of the process and outcome

methods used to evaluate the

effectiveness of each activity proposed,

including what will be evaluated, the

data to be used, who will perform the

evaluation and the time-frame for the

evaluation. The evaluation should

include progress in meeting the

objectives and conducting activities

during the project period.

6. Collaboration: A description of any

proposed collaboration with other

entities, including academic

institutions, Federal, State or local

agencies, institutes, associations,

laboratories, or experts. Applicant

should provide a letter from each

outside entity describing their

willingness and capacity to fulfill their

specific responsibilities.

7. Staff and Resources: A description

of the roles and responsibilities of the

project director and all other staff

members and collaborators.

Descriptions should include the

position titles, education and

experience, and the percentage of time

each will devote to the program.

Curriculum vitae for each critical staff

member and collaborator should be

included. Include a description of

current activities and previous

experience in injury prevention. Include

relevant experience and capability to

implement and maintain a database and

actively disseminate information.

8. Budget: A detailed budget with

accompanying narrative justifying all

individual budget items which make up

the total amount of funds requested. The

budget should be consistent with the

stated objectives and planned activities.

Evaluation Criteria

Applications will be reviewed and

evaluated according to the following

criteria:

1. Background and Need (10 Percent)

The extent to which the applicant

presents the magnitude of the need for

this project, demonstrates experience in

this area, and describes the likely

impact of their activities on the this

need.

2. Goals and Objectives (25 Percent)

The extent to which the goal(s) and

objectives are relevant to the purpose of

the proposal, feasible for

accomplishment during the project

period, measurable, and specific in

terms of what is to be done and the time

involved. The extent to which the

objectives address all activities

necessary to accomplish the purpose of

the proposal.

3. Methods (20 Percent)

The extent to which the applicant

provides a detailed description of all

proposed activities needed to achieve

each objective and the overall program

goal(s). The extent to which the

applicant provides a reasonable and

complete schedule for implementing all

activities. The extent to which position

descriptions, lines of command, and

collaborations are appropriate to

accomplishing the program goal(s) and

objectives.

4. Evaluation (20 Percent)

The extent to which the proposed

evaluation plan is detailed and capable

of documenting program process and

outcome measures (e.g., establishing a
32666 Federal Register / Vol. 63, No. 114 / Monday, June 15, 1998 / Notices

tracking system to record number of

calls received, type and number of

materials distributed). The extent to

which the applicant demonstrates staff

and/or collaborator availability,

expertise, and capacity to perform the

evaluation.

5. Facilities, Staff, and Resources (25

Percent)

The extent to which the applicant can

provide adequate facilities, staff and/or

collaborators, and resources to

accomplish the proposed goal(s) and

objectives during the project period. The

extent to which the applicant

demonstrates staff and/or collaborator

availability, expertise, previous

experience, and capacity to perform the

undertaking successfully.

6. Budget and Justification (Not Scored)

The extent to which the applicant

provides a detailed budget and narrative

justification consistent with the stated

objectives and planned program

activities.

Executive Order 12372

Applications are subject to

Intergovernmental Review of Federal

Programs as governed by Executive

Order (E.O.) 12372, which sets up a

system for State and local government

review of proposed Federal assistance

applications. Applicants (other than

federally recognized Indian tribal

governments) should contact their State

Single Point of Contact (SPOC) as early

as possible to alert them to the

prospective applications and receive

any necessary instructions on the State

process. For proposed projects serving

more than one State, the applicant is

advised to contact the SPOC of each

affected State. A current list of SPOCs

is included in the application kit. If

SPOCs have any State process

recommendations on applications

submitted to CDC, they should forward

them to Ron Van Duyne, Grants

Management Officer, ATTN: Joanne

Wojcik, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Room 300, Mailstop E–13, Atlanta, GA

30305, no later than 45 days after the

application deadline. The granting

agency does not guarantee to

‘‘accommodate or explain’’ for State

process recommendations it receives

after that date.

Indian tribes are strongly encouraged

to request tribal government review of

the proposed application. If tribal

governments have any tribal process

recommendations on applications

submitted to CDC, they should forward

them to Ron Van Duyne, Grants

Management Officer, ATTN: Joanne

Wojcik, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Room 300, Mailstop E–13, Atlanta, GA

30305, no later than 45 days after the

application deadline. The granting

agency does not guarantee to

‘‘accommodate or explain’’ for tribal

process recommendations it receives

after that date.

Public Health System Reporting

Requirements

This program is subject to the Public

Health System Reporting Requirements.

Under these requirements, all

community-based non-governmental

organizations submitting health services

applications must prepare and submit

the items identified below to the head

of the appropriate State and/or local

health agency(s) in the program area(s)

that may be impacted by the proposed

project no later than the application

deadline date of the Federal application.

The appropriate State and/or local

health agency is determined by the

applicant. The following information

must be provided:

A. A copy of the face page of the

application (SF 424).

B. A summary of the project that

should be titled ‘‘Public Health System

Impact Statement’’ (PHSIS), not to

exceed one page, and include the

following:

1. A description of the population to

be served;

2. A summary of the services to be

provided; and

3. A description of the coordination

plans with the appropriate State and/or

local health agencies.

If the State and/or local health official

should desire a copy of the entire

application, it may be obtained from the

State Single Point of Contact (SPOC) or

directly from the applicant.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance Number is 93.136.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of

information from 10 or more individuals

and funded by the cooperative

agreement will be subject to review by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act.

Application Submission and Deadline

The original and two copies of the

application PHS Form 5161–1 (Revised

7/92, OMB Control Number 0937–0189)

must be submitted to Joanne Wojcik,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–13, Atlanta, GA 30305, on or

before August 10, 1998.

1. Deadline: Applications shall be

considered as meeting the deadline if

they are either:

a. Received on or before the deadline

date; or

b. Sent on or before the deadline date

and received in time for submission to

the independent review committee. For

proof of timely mailing, applicant must

request a legibly dated U.S. Postal

Service postmark or obtain a legibly

dated receipt from a commercial carrier

or the U.S. Postal Service. Private

metered postmarks will not be

acceptable as proof of timely mailing.

2. Late Applications: Applications

that do not meet the criteria in 1.a. or

1.b. above are considered late

applications. Late applications will not

be considered in the current

competition and will be returned to the

applicant.

Where to Obtain Additional

Information

The program announcement and

application forms may be downloaded

from the Internet: www.cdc.gov (look

under funding). You may also receive a

complete application kit by calling 1–

888–GRANTS4. You will be asked to

identify the program announcement

number and provide a name and

mailing address. A complete

announcement kit will be mailed to you.

If you have questions after reviewing

the forms, for business management

technical assistance contact Joanne

Wojcik, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Mailstop E–13, Atlanta, GA 30305,

telephone (404) 842–6535, Internet

Address: jcw6@cdc.gov.

Programmatic assistance may be

obtained from Judy Stevens, Ph.D.,

National Center for Injury Prevention

and Control, Centers for Disease Control

and Prevention (CDC), 4770 Buford

Highway, NE, Mailstop K63, Atlanta,

GA 30341–3724, telephone (770) 488–

4652, Internet Address: jas2@cdc.gov.

Please refer to Announcement

Number 98088 when requesting
Federal Register / Vol. 63, No. 114 / Monday, June 15, 1998 / Notices 32667

information and submitting an

application.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report, Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report, Stock No. 017–001–00473–1)

referenced in the ‘‘INTRODUCTION’’

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

A copy of American Society for

Testing and Materials (ASTM) Number

1292 may be obtained from ASTM,

Customer Services, 1916 Race Street,

Philadelphia, PA 19103–1187,

telephone (215) 299–5585.

Dated: June 9, 1998.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–15805 Filed 6–12–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0378]

Agency Information Collection

Activities: Proposed Collection;

Comment Request; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice that appeared in the Federal

Register of May 19, 1998 (63 FR 27581).

The document announced an

opportunity for public comment on the

proposed collection of certain

information by the agency. The

document published with the incorrect

docket number. This document corrects

that error.

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.

In FR Doc. No. 98–13228, appearing

on page 27581 in the Federal Register

of Tuesday, May 19, 1998, the following

correction is made:

1. On page 27581, in the first column,

‘‘[Docket No. 98N–0194]’’ is corrected to

read ‘‘[Docket No. 98N–0378]’’.

Dated: June 5, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15770 Filed 6–12–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0357]

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 July 15,

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.

Medical Devices; Current Good

Manufacturing Practice (CGMP)

Quality System (QS) (21 CFR Part

820)—(OMB Control Number 0910–

0073—Reinstatement)

Under section 520(f) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360j(f)), the Secretary of the

Department of Health and Human

Services (the Secretary) has the

authority to prescribe regulations

requiring that the methods used in, and

the facilities and controls used for, the

manufacture, pre-production design

validation (including a process to assess

the performance of a device but not

including an evaluation of the safety

and effectiveness of a device), packing,

storage, and installation of a device

conform to CGMP, as described in such

regulations, to assure that the device

will be safe and effective and otherwise

in compliance with the act.

The CGMP/QS regulation

implementing the authority provided by

this statutory provision is found in part

820 of the Code of Federal Regulations

(21 CFR part 820) and sets forth basic

CGMP requirements governing the

design, manufacture, packing, labeling,

storage, installation, and servicing of all

finished medical devices intended for

human use. Section 820.20(a) through

(e) requires management with executive

responsibility to establish, maintain,

and/or review: The quality policy; the

organizational structure; the quality

plan; and the quality system procedures

of the organization. Section 820.22

requires the conduct and documentation

of quality system audits and reaudits.

Section 820.25(b) requires the

establishment of procedures to identify

training needs and documentation of

such training.

Section 820.30(a)(1) and (b) through

(j) requires, in the following respective

order, the establishment, maintenance,

and/or documentation of: Procedures to

control design of class III and class II

devices, and certain class I devices as

listed therein; plans for design and

development activities and updates;

procedures identifying, documenting,

and approving design input

requirements; procedures defining

design output, including acceptance

criteria, and documentation of approved

records; procedures for formal review of

design results and documentation of

results in the design history file (DHF);

procedures for verifying device design

and documentation of results and

approvals in the DHF; procedures for

validating device design, including

documentation of results in the DHF;

procedures for translating device design

into production specifications;

procedures for documenting, verifying

validating approved design changes

before implementation of changes; and

the records and references constituting

the DHF for each type of device.

Section 820.40 requires the

establishment and maintenance of

procedures for the review, approval,

issuance and documentation of required

records (documents) and changes to

those records.

Section 820.50 requires the

establishment and maintenance of

procedures and requirements to ensure

service and product quality, records of

acceptable suppliers and purchasing