38408 Federal Register / Vol. 63, No. 136 /Thursday, July 16, 1998 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Disease, Disability, and Injury

Prevention and Control Special

Emphasis Panel; Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following meeting.

Name: Disease, Disability, and Injury

Prevention and Control Special

Emphasis Panel (SEP): Cooperative

Agreement for Prevention Research

Centers, Program Announcement

#98028 meeting.

Times and Dates: 8:30–8:50 a.m.,

August 4, 1998 (Open). 9 a.m.–4:30

p.m., August 4, 1998 (Closed). 9 a.m.–

4:40 p.m., August 5, 1998 (Closed).

Place: National Center for HIV, STD,

and TB Prevention, CDC, Corporate

Square Office Park, Building 12, Room

1307 (Library), Atlanta, Georgia 30329.

Status: Portions of the meeting will be

closed to the public in accordance with

provisions set forth in section 552b(c)(4)

and (6), Title 5 U.S.C., and the

Determination of the Associate Director

for Management and Operations, CDC,

pursuant to Public Law 92–463.

Matters to be Discussed: The meeting

will include the review, discussion, and

evaluation of applications received in

response to Program Announcement

#98028.

Contact Person for More Information:

John R. Lehnnherr, Chief, Prevention

Support Office, National Center for HIV,

STD, and TB Prevention, CDC,

Corporate Square Office Park, 11

Corporate Square Boulevard, m/s E07,

Atlanta, Georgia 30329, telephone 404/

639–8025.

Dated: July 10, 1998.

Nancy C. Hirsch,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention CDC.

[FR Doc. 98–18937 Filed 7–15–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

National Workshop on Toxoplasmosis;

Meeting

The National Center for Infectious

Diseases (NCID), Division of Parasitic

Diseases (DPD) of the Centers for

Disease Control and Prevention (CDC)

announces the following meeting.

Name: National Workshop on

Toxoplasmosis: Preventing Congenital

Toxoplasmosis.

Times and Dates: 8:30 a.m.–6 p.m.,

September 9, 1998.; 8:30 a.m.–3 p.m.,

September 10, 1998.

Place: CDC, 1600 Clifton Road, Auditorium

A, Atlanta, GA 30333.

Status: Open to the public, limited only by

the space available.

Purpose: The purpose of this working

meeting is to define the key strategies to

reduce the burden of congenital

toxoplasmosis in the United States.

Matters to be Discussed: Participants will

include representatives from public, private,

and foreign organizations. They will (1)

define approaches to reduce the prevalence

of congenital toxoplasmosis, (2) identify data

needs to evaluate and/or implement these

strategies, and (3) identify critical next steps.

Agenda items are subject to change as

priorities dictate.

Written comments are welcome and should

be received by the contact person listed

below prior to the opening of the meeting.

Contact Person For More Information:

Vance Dietz, Epidemiology Branch, DPD,

NCID, CDC, M/S F–22, 1600 Clifton Road,

NE, Atlanta, Georgia 30333, telephone 770/

488–7771, fax 770/488–7761, e-mail

vxd0@cdc.gov.

Dated: July 10, 1998.

Nancy C. Hirsch,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention (CDC)

[FR Doc. 98–18938 Filed 7–15–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

Centers for Disease Control and

Prevention Statement of Organization,

Functions, and Delegations of

Authority

Part C (Centers for Disease Control

and Prevention) of the Statement of

Organization, Functions, and

Delegations of Authority of the

Department of Health and Human

Services (45 FR 67772–76, dated

October 14, 1980, and corrected at 45 FR

69296, October 20, 1980, as amended

most recently at 63 FR 31785–31786,

June 10, 1998) is amended to reflect the

establishment of the Office of Global

Health within the Office of the Director,

Centers for Disease Control and

Prevention (CDC), and the abolishment

of the International Health Program

Office.

Section C–B, Organization and

Functions, is hereby amended as

follows:

Delete in its entirety the title, mission,

and functional statement for the

International Health Program Office

(CG).

After the title and functional

statement for the Division of Media

Relations (CAA33), Office of

Communication (CAA, insert the

following:

Office of Global Health (CAB). Under

the direction of the Associate Director

for Global Health, the Office of Global

Health (OGH) provides leadership,

policy guidance, coordination, technical

expertise, and services to promote the

agency’s global health initiatives. In

carrying out this mission, OGH: (1)

Advises the CDC Director on global

health issues relevant to the agency; (2)

assesses evolving global health issues

and, in cooperation with Ministries of

Health and other appropriate

institutions, identifies and develops

activities to which the application of

CDC’s technical expertise would be of

maximum public health benefit; (3)

collaborates with CDC Centers/Institute/

Offices (CIO’s), other federal agencies,

countries, and organizations, as

appropriate, to assist CIO’s in the

development of appropriate policy for

global health initiatives for which they

have responsibility; (4) coordinates

plans for the allocation of global health

resources and assists in the

development of external funding

sources for programs and projects; (5)

coordinates cross-cutting CDC global

health enterprises; (6) provides

leadership in the development and

implementation of the CDC Global

Health Strategic Plan and guides CDC’s

efforts to enhance institutional global

health capacity; (7) coordinates

international collaboration with external

partners, including administration,

budgets, and technical assistance to

assure that agency obligations are met;

(8) provides for the enhancement of

internal and external global health

partnerships; (9) coordinates the

recruitment and orientation of CDC

assignees to other agencies or countries;

(10) stimulates research and program

development through the dissemination

of information acquired through ongoing global health initiatives; (11)

provides global health expertise to CIO

international projects, as appropriate

and requested by CIO’s; (12) coordinates

bilateral health agreements between

CDC and foreign governments; (13)

administers the Exchange Visitors

Program; (14) in carrying out the above

responsibilities, coordinates activities

with CDC/CIO’s, the Office of Public

Health and Science’s Office of

International and Refugee Health, the

Department of Health and Human
Federal Register / Vol. 63, No. 136 /Thursday, July 16, 1998 / Notices 38409

Services’ Office of International Affairs,

other government and nongovernment

organizations, and academic

institutions, as appropriate.

Office of the Director (CAB1). (1)

Manages, directs, and coordinates the

activities of the OGH; (2) provides

leadership in developing OGH policy,

program planning, implementation, and

evaluation; (3) coordinates the

management of legislated international

ceiling exempt positions; (4) coordinates

the CDC cable clearance function; (5)

provides for the orientation and

scheduling of foreign visitors to CDC; (6)

provides CDC support services related

to international travel, such as the

acquisition of passports, visas, and

international clearances; (7) maintains

international travel database and

develops related reports; (8) serves as

the CDC focal point for information

regarding CDC’s overseas assignees.

Dated: July 7, 1998.

Claire V. Broome, M.D.,

Acting Director.

[FR Doc. 98–18935 Filed 7–15–98; 8:45 am]

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0494]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

the requirements for domestic

manufacturers and initial importers of

devices to register their establishments

and list their devices.

DATES: Submit written comments on the

collection of information by September

14, 1998.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. All comments should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301827–1223

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Medical Device Registration and

Listing—21 CFR 807

Section 510 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

360) requires that manufacturers and

initial importers engaged in the

manufacture, preparation, propagation,

compounding, assembly, or processing

of medical devices intended for human

use and in commercial distribution

register their establishments and list the

devices they manufacture with FDA.

This is accomplished by completing

FDA Form 2891, ‘‘Initial Registration of

Device Establishment’’ and FDA Form

2892, ‘‘Medical Device Listing.’’ In

addition, each year active, registered

establishments must notify FDA of

changes to the current registration and

device listing for the establishment.

Annual changes to current registration

information are pre-printed on FDA

Form 2891a and sent to registered

establishments. The form must be sent

back to FDA’s Center for Devices and

Radiological Health (CDRH), even if no

changes have occurred. Changes to

listing information are submitted on

Form 2892. Refurbishers/reconditioners

are not required to register or list;

however, FDA will accept voluntary

registration and listings from firms that

wish to be registered with FDA.

In addition, under § 807.31 (21 CFR

807.31), each owner or operator is

required to maintain a historical file

containing the labeling and

advertisements in use on the date of

initial listing, and in use after October

10, 1978, but before the date of initial

listing. The owner or operator must

maintain in the historical file any

labeling or advertisements in which a

material change has been made anytime

after initial listing, but may discard

labeling and advertisements from the

file 3 years after the date of the last

shipment of a discontinued device by an

owner or operator. Along with the

recordkeeping requirements above, the

owner or operator must be prepared to

submit to FDA upon specific request all

labeling and advertising mentioned

above (§ 807.31(e)).

The information collected through

these provisions is used by FDA to

identify firms subject to FDA’s

regulations and is used to identify

geographic distribution in order to

effectively allocate FDA’s field

resources for these inspections and to

identify the class of the device which

determines the inspection frequency.

When complications occur with a

particular device or component,

manufacturers of similar or related

devices can easily be identified.

The likely respondents to this

information collection will be domestic

establishments engaged in the

manufacture, preparation, propagation,

compounding, assembly, or processing

of medical devices intended for human

use and commercial distribution.

FDA estimates the burden of this

collection of information as follows: