32234 Federal Register / Vol. 63, No. 113 / Friday, June 12, 1998 / Notices

HIV–1, HIV–2, hepatitis B virus,

hepatitis C virus, HTLV-I, HTLV-II, and

Treponema palladum. A request for

determination may be based upon

infectious agent tests performed using

test kits other than those licensed or

approved by FDA. In such cases, FDA

suggests that the request contain a copy

of the labeling for the test kit used,

translated into English, as part of the

submission; and

• A copy of the product’s label. FDA

recommends that the label include

information such as the product’s

descriptive name; the name(s) and

address(es) of establishments collecting,

preparing, labeling, or pooling the

source material; donor, lot, or pool

numbers relating the unit to the donor;

the recommended storage temperature

(in degrees Celsius); the product’s

quantity; statements such as ‘‘Import for

Export,’’ ‘‘Not for Use in Products

Subject to Licensure Under Section 351

of the Public Health Service Act,’’ and

‘‘For Manufacturing Use Only’’ or ‘‘For

Manufacturing into Noninjectable

Products Only;’’ statements indicating

that the product has been tested for

infectious disease agents and, if the

product has tested positive for an

infectious disease agent, the term

‘‘BIOHAZARD’’ as well as any other

appropriate warnings or special

handling instructions.

A request for determination may be

sent to the Center for Biologics

Evaluation and Research, Office of

Compliance, Division of Case

Management (HFM–610), 1401

Rockville Pike, Rockville, MD 20852–

1448. If FDA determines that the blood,

blood component, source plasma, or

source leukocyte, or a component,

accessory, or part meets the appropriate

circumstances and conditions to permit

its importation into the United States,

FDA will notify the person requesting

the determination that it has granted

permission to import the article.

XII. For Further Information Contact:

For animal drugs: Drugs Team,

Division of Compliance, Center for

Veterinary Medicine, Food and

Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1785.

For biologics: Division of Case

Management (HFM–610), Office of

Compliance, Center for Biologics

Evaluation and Research, Food and

Drug Administration, 1401

Rockville Pike, rm. 200N, Rockville,

MD 20852–1448, 301–827–6201.

For devices: Division of Program

Operations (HFZ–305), Center for

Devices and Radiological Health,

Food and Drug Administration,

2094 Gaither Rd., Rockville, MD

20850, 301–594–4699.

For drugs: Division of Labeling and

Nonprescription Drug Compliance

(HFD–310), Center for Drug

Evaluation and Research, Food and

Drug Administration, 7520 Standish

Pl., Rockville, MD 20855–2737,

301–594–0063.

For drugs exported for investigational

use under § 312.110: Office of

International Affairs (HFG–1), Food

and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–4480.

For food additives, color additives,

and dietary supplements: Office of

Field Programs (HFS–602), Center

for Food Safety and Applied

Nutrition, Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–

4187.

These offices may have additional

guidance documents and information on

specific export topics or products.

For general policy questions: Office of

Policy (HF–23), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–

3344.

Dated: June 2, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15696 Filed 6–11–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration.

[Document Identifier: HCFA–724]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration.

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 this 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: Extension of a currently

approved collection; Title of

Information Collection: Medicare/

Medicaid Psychiatric Hospital Survey

Data and Supporting Regulations

Contained in 42 CFR 482.60, 482.61 and

482.62; Form No.: HCFA–724 (OMB#

0938–0378); Use: The information

collected on this form will assist HCFA

in maintaining an accurate data base on

providers participating in the Medicare

psychiatric hospital program. The

HCFA–724 has two parts; part one is

completed by the facility (i.e., location,

number of beds, number of admissions)

and part two is completed by the survey

team (i.e, dates of survey, type of

survey, survey team composition);

Frequency: Annually; Affected Public:

Federal government, Business or other

for-profit, Not-for-profit institutions,

and State, local or tribal government;

Number of Respondents: 350; Total

Annual Responses: 350; Total Annual

Hours: 175.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB desk officer: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: June 2, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 98–15648 Filed 6–11–98; 8:45 am]

BILLING CODE 4120–03–P