64716 Federal Register / Vol. 65, No. 210 / Monday, October 30, 2000 / Notices

average 29.5 hours per response,

including the time for reviewing

instructions, gathering and maintaining

the data needed, and reviewing the

collection of information.

An agency may not conduct or

sponsor, and a person is not required to

respond to, a collection of information

unless it displays a currently valid OMB

control number.

I. Receipt of Applications

Applications must either be hand

delivered or mailed to the address in

Section E, The Application Process. The

Administration for Native Americans

cannot accommodate transmission of

applications by fax or through other

electronic media. Therefore,

applications transmitted to ANA

electronically will not be accepted

regardless of date or time of submission

and time of receipt. Videotapes and

cassette tapes may not be included as

part of a grant application for panel

review.

Applications and related materials

postmarked after the closing date will be

classified as late.

1. Deadlines

• Mailed applications shall be

considered as meeting an announced

deadline if they are either received on

or before the deadline date or sent on or

before the deadline date and received by

ACF in time for the independent review

to: U.S. Department of Health and

Human Services, Administration for

Children and Families, ACYF/Office of

Grants Management, 370 L’Enfant

Promenade, SW, Mail Stop HHH 326–F,

Washington, D.C. 20447–0002.

Attention: Lois B. Hodge ANA No.

93612–992.

• Applicants are cautioned to request

a legibly dated U.S. Postal Service

postmark or to obtain a legibly dated

receipt from a commercial carrier or the

U.S. Postal Service. Private metered

postmarks shall not be acceptable as

proof of timely mailing.

• Applications hand carried by

applicants, applicant couriers, or by

overnight/express mail couriers shall be

considered as meeting an announced

deadline if they are received on or

before the deadline date or postmarked

on or before the deadline date, Monday

through Friday (excluding Federal

holidays), between the hours of 8:00 am

and 4:30 p.m. at: U.S. Department of

Health and Human Services,

Administration for Children and

Families, ACYF/Office of Grants

Management, ACF Mailroom, 2nd Floor

Loading Dock, Aerospace Center, 901 D

Street, SW, Washington, D.C. 20024.

(Applicants are cautioned that express/

overnight mail services do not always

deliver as agreed.)

• ACF cannot accommodate

transmission of applications by fax or

through other electronic media.

Therefore, applications transmitted to

ACF electronically will not be accepted

regardless of date or time of submission

and time of receipt.

• No additional material will be

accepted, or added to an application,

unless it is postmarked by the deadline

date.

2. Late applications

Applications that do not meet the

criteria above are considered late

applications. ACF shall notify each late

applicant that its application will not be

considered in the current competition.

3. Extension of deadlines

The Administration for Children and

Families may extend an application

deadline for applicants affected by acts

of God such as floods and hurricanes, or

when there is a widespread disruption

of the mails. A determination to extend

or waive deadline requirements rests

with the Chief Grants Management

Officer.

(Catalog of Federal Domestic Assistance

Program Numbers: 93.612 Native American

Programs; and 93.587 Promoting the Survival

and Continuing Vitality of Native American

languages)

Dated: October 3, 2001.

Gary Mounts,

Acting Commissioner, Administration for

Native Americans.

[FR Doc. 00–27708 Filed 10–27–00; 8:45 am]

BILLING CODE 4184–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1426]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Emergency Health Surveys

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.

DATES: Submit written comments on the

collection of information by November

29, 2000.

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: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Peggy 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 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Emergency Health Surveys

Under section 519 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360(i)), FDA is authorized to

require: (1) Manufacturers to report

medical-device-related deaths, serious

injuries, and malfunctions; and (2) user

facilities to report device-related deaths

directly to FDA and to manufacturers,

and to report serious injuries to the

manufacturer. Section 522 of the act (21

U.S.C. 360(l)) authorizes FDA to require

manufacturers to conduct postmarket

surveillance of medical devices. Section

705(b) of the act (21 U.S.C. 375(b))

authorizes FDA to collect and

disseminate information regarding

medical products or cosmetics in

situations involving imminent danger to

health or gross deception of the

consumer. Section 903(b)(2) of the act

(21 U.S.C. 393(b)(2)) authorizes the

Commissioner of Food and Drugs (the

Commissioner) to implement general

powers (including conducting research)

to effectively carry out the mission of

FDA. These sections of the act enable

FDA to enhance consumer protection

from risks associated with medical

device usage that are not foreseen or

apparent during the premarket

notification and review process.

Currently FDA monitors medical

product related postmarket adverse

events via both the mandatory and

voluntary MedWatch Reporting Systems

using FDA Forms 3500 and 3500A

(OMB Control No. 0910–0281).

FDA is seeking OMB clearance to

collect information via a series of

surveys, thus implementing section

705(b) of the act and the

Commissioner’s authority as specified

in section 903(b)(2) of the act.

Participation in these surveys will be

voluntary. This request covers

Federal Register / Vol. 65, No. 210 / Monday, October 30, 2000 / Notices 64717

emergency health surveys for general

type medical facilities; specialized

medical facilities (those known for

cardiac surgery, obstetrics/gynecology

services, pediatric services, etc.); and

health professionals, but more typically

risk managers working in medical

facilities.

FDA will use the information

gathered from these surveys to quickly

obtain vital information from the

appropriate clinical sources so that FDA

may take appropriate public health or

regulatory action. FDA projects 10

emergency health surveys per year with

a sample of between 50 and 200

respondents per survey.

In the Federal Register of August 3,

2000 (65 FR 47734), the agency

requested comments on the proposed

collection of information. No comments

were received.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

200 10 (maximum) 2,000 2 4,000

1There are no capital costs or operating and maintenance costs associated with this collection of information.

These estimates are based on the

maximum sample size per questionnaire

that FDA could analyze in a timely

manner. The annual frequency of

respondent was determined by the

maximum number of questionnaires

that will be sent to any individual

respondent. Some respondents may be

contacted only one time per year, while

another respondent may be contacted

several times, depending on the medical

device under evaluation. It is estimated

that, given the expected type of issues

that will be addressed by the surveys, at

a maximum it will take 2 hours for a

respondent to gather the requested

information and fill in the answers.

Dated: October 23, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–27733 Filed 10–27–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4561–N–70]

Notice of Submission of Proposed

Information Collection to OMB;

Financial Statement of Corporate

Applicant for Cooperative Housing

Mortgage

AGENCY: Office of the Chief Information

Officer, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

has been submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments Due Date: November

29, 2000.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

approval number (2502–0058) and

should be sent to: Joseph F. Lackey, Jr.,

OMB Desk Officer, Office of

Management and Budget, Room 10235,

New Executive Office Building,

Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Wayne Eddins, Reports Management

Officer, Q, Department of Housing and

Urban Development, 451 Seventh Street,

Southwest, Washington, DC 20410; email Wayne_Eddins@HUD.gov;

telephone (202) 708–2374. This is not a

toll- (2) the office of the agency to

collect the information; (3) the OMB

approval number, if applicable; (4) the

description of the need for the

information and its proposed use; (5)

the agency form number, if applicable;

(6) what members of the public will be

affected by the proposal; (7) how

frequently information submissions will

be required; (8) an estimate of the total

number of hours needed to prepare the

information submission including

number of respondents, frequency of

response, and hours of response; (9)

whether the proposal is new, an

extension, reinstatement, or revision of

an information collection requirement;

and (10) the name and telephone umber

of an agency official familiar with the

proposal and of the OMB Desk Officer

for the Department.

This Notice also lists the following

information:

Title of Proposal: Financial Statement

of Corporate Applicant for Cooperative

Housing Mortgage.

OMB Approval Number: HUD–93232–

A.

Description of The Need For The

Information and Its Proposed Use: HUD

insures mortgages covering property

held by a non-profit cooperative

ownership housing cooperation. The

Department requires information on the

applicant’s financial and credit history

to determine the capability and capacity

of the borrower corporation and the

individual members to meet the

statutory requirement for repayment.

Frequency of Submission: Monthly.

Reporting Burden:

Number of respondents x Frequency of response x Hours per response = Burden hours

1,500 1 2 3,000