[Federal Register Volume 60, Number 18 (Friday, January 27, 1995)]
[Notices]
[Pages 5432-5433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2120]



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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]
BILLING CODE 4160-17-M