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,

January 6, 1995.

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

request)

1. Registration of Cosmetic Product Establishment--0910-0027

(Extension, no change)--The voluntary registration of cosmetic

manufacturers and repackers supplies the Food and Drug Administration

(FDA) with current locations for on-site inspections, addresses for

information and regulatory mailings, business trading names supplying

product distribution sources, and aids FDA in responding to FOI

requests. Respondents: Business or other for-profit; Number of

Respondents: 50; Number of Responses per Respondent: 1; Average Burden

per Response: 0.4 hour; Estimated Annual Burden: 20 hours.

2. Progress Toward Eliminating Occupational Lead Poisoning: Survey

on the Use of Lead in Industry and Control of Occupational Lead

Exposure in Ohio--New--This suvey will examine the types of lead-using

companies doing environmental and/or biological monitoring. The results

will be used to target the technical assistance resources of the

National Institute of Occupational Safety and Health to those

industries with uncontrolled lead exposures and those industries that

should be doing monitoring and are not. Respondents: Business or other

for-profit; Number of Respondents: 1,806; Number of Responses per

Respondent: 1; Average Burden per Response: 3 hours; Estimated Annual

Burden: 5,413 hours.

3. Small Business Innovation Research Grant Applications Phase I

and Phase II and Small Business Technology Transfer Grant Applications

Phase I and II--0925-0195 (Revision)--The purpose of the Small Business

[[Page 5433]] Innovation Research (SBIR) Phase I and Phase II

applications and the Small Business Technology Transfer (STTR) Phase I

and Phase II applications is to provide a vehicle by which small

business concerns can apply for available research funds. This

information is used by PHS to determine those applicants scientifically

and administratively qualified to receive public funds for projects

relevant to PHS programs. Respondents: Business or other for-profit.

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

Average

Number of burden

Title Number of responses per

respondents per response

respondent (hours)

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

SBIR and STTR phase I................ 3,400 1 30

SBIR and STTR phase II............... 600 1 40

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

Estimated Total Annual Burden: 126,000 hours.

4. Pesticide Residue Study (15 months) of Monthly Rice Production

Volumes from Operating U.S. Rice Mills--New--As part of the Food and

Drug Administration's (FDA) continuing effort to improve the pesticide

program, monitoring studies are needed. Department of Agriculture

inspectors, which regularly inspect mills, have obtained monthly

samples from known domestic rice production mills over a 15-month

period. FDA is proposing to query these domestic rice mills, which

process virtually all rice milled in the U.S., to obtain information on

their monthly ``pounds of finished rice produced'' between October 1993

and December 1994. FDA needs this information to determine how this

sampling approach differs historically from the data obtained from the

Agency's traditional sampling approach. Respondents: Business or other

for-profit; Number of Respondents: 43; Number of Responses per

Respondent: 1; Average Burden per Response: 1 hour; Estimated Annual

Burden: 43 hours.

5. Protection of Human Subjects--Recordkeeping and Reporting

Requirements Institutional Review Boards (21 CFR 56)--0910-0130

(Reinstatement)--Documentation of IRB activities and retention of those

records are necessary for the Food and Drug Administration to be able

to assess compliance with regulations during inspections. Respondents:

Business or other for-profit, Federal Government, Not for-profit

institutions; Number of Respondents: 2,000; Number of Responses per

Respondent: 1; Average Burden per Response: 65 hours; Estimated Annual

Burden: 131,400 hours.

6. Services Research Outcomes Study (SROS)--Main Study--0930-0167--

The Service Research Outcomes Study employs a national sample of

substance abuse treatment clients to gather information required in the

formulation of national drug policy. A sample of 3,000 treatment

clients will be followed up through records and personal interview to

obtain information on drug use, criminal activity, and treatment

utilization patterns. Respondents: Individuals or households; Number of

Respondents: 2,295; Number of Responses per Respondent: 1; Average

Burden per Response: 2.005 hours; Estimated Annual Burden: 4,602 hours.

7. Color Additive Certification, 21 CFR 80, Subpart B--0910-0216--

(Extension, no change)--The information collected is required by the

Food and Drug Administration for the purpose of responding to requests

for ``Color Certification'' of color additives as required in Section

721 of the FD&C Act and the regulations promulgated in 21 CFR Part 80.

The activity includes chemical analysis for batch composition of a

representative sample to insure compliance with applicable

specifications and issuance of a certification lot number. Respondents

are any persons requesting certification of a manufactured batch of

color additive. Respondents: Business or other for-profit.

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

Average

Number of burden

Title Number of responses per

respondents per response

respondent (hours)

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

Reporting: Request for Certification--

22 CFR 80.21........................ 27 145 .216

Samples of Batch Colors--22 CFR 80.22 27 145 0.033

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

Recordkeeping: Records of

Distribution--21 CFR 80.39.......... 27 1 36.3

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

Estimated Total Annual Burden: 1,958 hours.

Written comments and recommendations concerning the proposed

information collections should be sent within 30 days of this notice

directly to OMB Desk Officer designated below at the following address:

Shannah Koss, Human Resources and Housing Branch, New Executive Office

Building, Room 10235, Washington, D.C. 20503.

Dated: January 23, 1995.

James Scanlon,

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

Evaluation.

[FR Doc. 95-2120 Filed 1-26-95; 8:45 am]

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