[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.
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Average
Number of burden
Title Number of responses per
respondents per response
respondent (hours)
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SBIR and STTR phase I................ 3,400 1 30
SBIR and STTR phase II............... 600 1 40
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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.
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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
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Recordkeeping: Records of
Distribution--21 CFR 80.39.......... 27 1 36.3
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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
