[Federal Register Volume 59, Number 217 (Thursday, November 10, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27888]


[[Page Unknown]]

[Federal Register: November 10, 1994]


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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

    The following request has been submitted to the Office of 
Management and Budget (OMB) for clearance in compliance with the 
Paperwork Reduction Act (44 USC Chapter 35). Expedited review by OMB 
has been requested as described below.
    Call PHS Reports Clearance Officer on 202-690-7100 for a copy of 
the submission.
    Cosmetics Adverse Reaction Hotline Reports Guide--New--In support 
of the Food and Drug Administration's (FDA) Women's Health Initiatives 
Program, the agency is undertaking a consumer cosmetics adverse 
reaction program to enable the public to report directly to FDA any 
adverse reactions they encounter with cosmetic product usage. Both men 
and women will be able to report adverse rections encountered.
    Under the Food, Drug and Cosmetic Act, cosmetics are defined as 
``articles intended to be rubbed, poured, sprinkled, or sprayed on, 
introduced into, or otherwise applied to the human body or any part 
thereof for cleansing, beautifying, promoting attractiveness, or 
altering the appearance.'' Cosmetic products and ingredients are 
regulated after, not before, they are marketed and thus are not subject 
to premarket approval for safety or effectiveness for their intended 
use. They can only be removed from the market place when it can be 
demonstrated that they are adulterated or misbranded under sections 601 
and 602 of the Act.
    Almost everyone uses some cosmetic products, and many people use a 
great many. The number of cosmetic products grows daily and there is 
great diversity of intended uses and a potential for consumer harm. In 
addition, product formulation technology has advanced to the point 
where manufacturers can put together highly sophisticated products that 
were unknown even a few years ago. With this vigorous activity in the 
cosmetic market place, there is considerable uncertainty about the 
prevalence and intensity of product problems being experienced by the 
public and there is limited capability to detect emerging problems due 
to new types of products or changing consumer usages.
    The agency currently has two monitoring systems in place, the 
Cosmetic Adverse Reaction Monitoring Program and the Voluntary Cosmetic 
Product Experience Program. However, both of these systems are passive 
in nature and each has limitations in terms of timeliness or 
completeness of reporting.
    The toll-free hotline program will allow consumers to report to the 
agency detailed information on the nature and severity of cosmetic 
adverse reactions that they experience. Direct entry of information 
reported into an on-line computer database will minimize possible 
errors and expedite the timeliness of data processing.
    Such information will enable the agency to know the magnitude of a 
problem in real time. The agency also intends to provide the cosmetic 
industry with a listing of their products which have adverse reaction 
rates greater than the norm for similar products. This will enable 
cosmetic companies to compare their products to the rest of the 
industry and to correct quickly a problem with a cosmetic product.
    The cosmetic adverse reaction reports received through the hotline 
will be used in conjunction with the cosmetic product ingredient 
registration program information received in accordance with 21 CFR 
720. Correlation of hotline data with ingredient data from over 28,000 
cosmetic product formulations will give FDA scientists a valuable 
insight into potentially unsafe ingredients in cosmetic products.
    OMB has been requested to review and approved the hotline reports 
guide on an expedited basis by Friday, December 2. This approval date 
is necessary in order to implement the national toll-free hotline 
service on December 7. This date is crucial because of the outreach 
program needed to promote consumer awareness of cosmetic adverse 
reactions and have the hotline available for the holiday season. In 
keeping with the requirements for expedited review, we are publishing 
the interview guide and associated instructions. It should be noted 
that the information will actually be collected using a computer 
assisted telephone interview program which presents to the interviewer 
screens containing the data items and associated instructions.
    Respondents: Individuals or households; Number of Respondents: 
30,000; Number of Responses per Respondent; 1; Average Burden per 
Response: .25 hour; Estimated Annual Burden: 7,500 hours.
    OMB Desk Officer: Steve Semenuk.
    Because of the time frame in which OMB has been asked to act on 
this submission, any comments and recommendations for the proposed 
information collection should be provided directly to the OMB Desk 
Officer designated above by telephone at (202) 395-7316 or by express 
mail at the following address: Human Resources and Housing Branch, New 
Executive Office Building, Room 10235, Washington, D.C. 20503.

    Dated: November 7, 1994.
James Scanlon,
Director, Division of Data Policy, Office of Health Planning and 
Evaluation.

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[FR Doc. 94-27888 Filed 11-9-94; 8:45 am]
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