Agency Forms Submitted to the Office of Management and Budget for Clearance

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

Agency Forms Submitted to the Office of Management and Budget for

Clearance

Each Friday the Public Health Service (PHS) publishes a list of

information collection requests it has submitted to the Office of

Management and Budget (OMB) for clearance in compliance with the

Paperwork Reduction Act (44 U.S.C. Chapter 35). The following requests

have been submitted to OMB since the list was last published on Friday,

October 21, 1994.

(Call PHS Reports Clearance Officer on 202-690-7100 for copies of

request).

1. MEDWATCH: FDA's Medical Product Reporting Program--0910-0291

(Extension, no change)--This form is used for reporting adverse events

and product problems with medications, devices, and other products

(such as dietary supplements) that are regulated by the agency.

Respondents: Businesses or other for-profit, small businesses or

organizations; Number of Respondents: 83,694; Number of Responses per

Respondent: 3.8; Average Burden per Response: .93 hour; Estimated

Annual Burden: 296,719 hours.

2. Application for Participation in the Indian Health Service

Scholarship Program--0917-0006 (Reinstatement)--The information to be

collected will be used to select the Indian Health Service pregraduate,

preparatory, and/or health professions scholarship grantees and to

monitor progress of award. Respondents: Individuals or households,

State or local governments, businesses or other for-profit, non-profit

institutions, small businesses or organizations; Number of Respondents:

11,730; Number of Responses per Respondent: 1; Average Burden per

Response: .46 hours; Estimated Annual Burden: 5,395 hours.

3. Community Health Center User and Visit Survey--New--A two-part

study will be conducted of Community Health Centers (CHCs) funded under

Section 330 of the PHS Act. Personal interviews with CHC users will

provide information on health status, utilization of and satisfaction

with services, and sources of care. Data will also be abstracted from

medical records for a sample of visits. Respondents: Individuals or

households, Non-profit institutions.

------------------------------------------------------------------------

Average burden

Title No. of No. of responses per response

respondents per respondent (hours)

------------------------------------------------------------------------

User survey....... 2,000 1 2

Medical visit

abstraction...... 50 1 30

CHC induction

interview........ 50 1 3

------------------------------------------------------------------------

Estimated Total Annual Burden....5,650 hours.

4. Transmittal of Periodic Reports and Promotional Material for New

Animal Drugs--0910-0019 (Reinstatement)--These records and reports are

used to facilitate a determination as to whether there may be grounds

for suspending or withdrawing approval of the application, or whether

any applicable regulation should be amended or repealed. The

respondents are the sponsors of approved New Animal Drugs Applications

whose numbers have increased over the years. Respondents: Businesses or

other for-profit.

------------------------------------------------------------------------

Average burden

Title No. of No. of responses per response

respondents per respondent (hours)

------------------------------------------------------------------------

Reporting, 21 CFR

510.302(a)....... 1,500 2.3 .5

Recordkeeping, 21

CFR 510.300(a)... 1,500 1 10.35

------------------------------------------------------------------------

Estimated Total Annual Burden ... 17,275 hours.

Written comments and recommendations concerning the proposed

information collections should be sent within 30 days of this notice

directly to the OMB Desk Officer designated below at the following

address: Shannah Koss, Human Resources and Housing Branch, New

Executive Office Building, room 10235, Washington, DC 20503.

Dated: October 27, 1994.

James Scanlon,

Director, Division of Data Policy, Office of Health Planning and

Evaluation.

[FR Doc. 94-27269 Filed 11-3-94; 8:45 am]

BILLING CODE 4160-17-M