Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Notices 51873

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:

Export of Medical Devices—Foreign

Letters of Approval—21 U.S.C. 381(e)(2)

(OMB Control No. 0910–0264—

Reinstatement)

Section 801(e)(2) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 381(e)(2)) provides for the

exportation of an unapproved device

under certain circumstances if the

exportation is not contrary to the public

health and safety and it has the approval

of the foreign country to which it is

intended for export.

Requesters communicate (either

directly or through a business associate

in the foreign country) with a

representative of the foreign government

to which they seek exportation, and

written authorization must be obtained

from the appropriate office within the

foreign government approving the

importation of the medical device. FDA

uses the written authorization from the

foreign country to determine whether

the foreign country has any objection to

the importation of the device.

The respondents to this collection of

information are companies that seek to

export medical devices.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN

No. of Respondents Annual Frequency per

Response Total Annual Responses Hours per Response Total Hours

20 1 20 0.5 10

There are no capital costs or operating and maintenance costs associated with this collection of information.

These estimates are based on the

experience of FDA’s medical device

program personnel. In fiscal year 1995,

FDA received approximately 800

requests from U.S. firms to export

medical devices under section 801(e)(2)

of the act. However, the enactment of

the Food and Drug Export Reform and

Enhancement Act of 1996 has greatly

reduced the number of export permit

requests made under section 801(e)(2) to

an estimated 20 per year.

Dated: September 26, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–26257 Filed 10–2–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97F–0406]

Sveriges Sta ̈rkelseproducenter; Filing

of Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Sveriges Sta ̈rkelseproducenter has

filed a petition proposing that the food

additive regulations be amended to

provide for the safe use of industrial

starch modified by treatment with up to

21 percent 2,3-epoxypropyl

trimethylammonium chloride, as a

component of food-contact articles.

FOR FURTHER INFORMATION CONTACT:

Andrew J. Zajac, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3095.

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 7B4558) has been filed by

Sveriges Sta ̈rkelseproducenter, c/o

Kirschman Associates, P.O. Box 88,

Emmaus, PA 18049. The petition

proposes to amend the food additive

regulations in § 178.3520 Industrial

starch-modified (21 CFR 178.3520) to

provide for the safe use of industrial

starch modified by treatment with up to

21 percent 2,3-epoxypropyl

trimethylammonium chloride, as a

component of food-contact articles.

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: September 15, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–26256 Filed 10–2–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–212]

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: New Collection; Title of

Information Collection: Survey of

Primary Caregivers for the District of

Columbia’s Managed Care

Demonstration for Disabled and Special

Needs Children and Supporting Statute

Section 1115(a) of the Social Security

Act; Form No.: HCFA-R–212; Use: This

survey will collect information from

primary caregivers of Disabled and

Special Needs Children about

household composition, access to care,

health status, functional status, home

care, family care giving burden,

satisfaction, and out-of-pocket

expenditures on disabled and special

needs children living in the District of

Columbia who are enrolled in the

Supplemental Security Income (SSI)

program. This instrument is designed to

support a series of analytic studies,

which will eventually provide HCFA,

Assistant Secretary of Planning and