[Federal Register Volume 67, Number 196 (Wednesday, October 9, 2002)]
[Notices]
[Pages 62977-62978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25642]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0268]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Cosmetic Product Voluntary Reporting Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
November 8, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Cosmetic Product Voluntary Reporting Program--(21 CFR 720.4, 720.6, and 
720.8)--(OMB Control Number 0910-0030)--Extension

    Under the Federal Food, Drug, and Cosmetic Act (the act), cosmetic 
products that are adulterated under section 601 of the act (21 U.S.C. 
361) or misbranded under section 602 of the act (21 U.S.C. 362) cannot 
legally be distributed in interstate commerce. To assist FDA in 
carrying out its responsibility to regulate cosmetics, FDA requests 
under part 720 (21 CFR part 720), but does not require, that firms that 
manufacture, pack, or distribute cosmetics file with the agency an 
ingredient statement for each of their products (Sec.  720.4). 
Ingredient statements for new submissions (Sec.  720.4) are reported on 
Form FDA 2512, ``Cosmetic Product Ingredient Statement,'' and on Form 
FDA 2512a, a continuation form. Changes in product formulation (Sec.  
720.6) are also reported on Forms FDA 2512 and FDA 2512a. When a firm 
discontinues the commercial distribution of a cosmetic, FDA requests 
that the firm file Form FDA 2514, ``Discontinuance of Commercial 
Distribution of Cosmetic Product Formulation'' (Sec.  720.6). If any of 
the information submitted on or with these forms is confidential, the 
firm may submit a request for confidentiality under Sec.  720.8.
    FDA uses the information received on these forms as input for a 
computer-based information storage and retrieval system. These 
voluntary formula filings provide FDA with the best information 
available about cosmetic product formulations, ingredients and their 
frequency of use, businesses engaged in the manufacture and 
distribution of cosmetics, and approximate rates of product 
discontinuance and formula modifications. FDA's database also lists 
cosmetic products containing ingredients suspected to be carcinogenic 
or otherwise deleterious to the public health. The information provided 
under the Cosmetic Product Voluntary Reporting Program assists FDA 
scientists in evaluating reports of alleged injuries and adverse 
reactions to the use of cosmetics. The information also is utilized in 
defining and planning analytical and toxicological studies pertaining 
to cosmetics.
    FDA shares nonconfidential information from its files on cosmetics 
with consumers, medical professionals, and industry. For example, by 
submitting a Freedom of Information Act request, consumers can obtain 
information about which products do or do not contain a specified 
ingredient and about the levels at which certain ingredients are 
typically used. Dermatologists use FDA files to cross-reference 
allergens found in patch test kits with cosmetic ingredients. The 
Cosmetic, Toiletry, and Fragrance Association, which is conducting a 
review of ingredients used in cosmetics, has relied on data provided by 
FDA in selecting ingredients to be reviewed based on frequency of use.
    The Cosmetic Product Voluntary Reporting Program was suspended 
during fiscal year (FY) 1998 due to a lack of budgetary funding and was 
reinstated at the beginning of FY 1999. The estimated hour burden is 60 
percent of the previous level reported in 1999. In general, the larger 
cosmetic companies have resumed participating in the program, whereas 
the smaller companies are lagging.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                                  Annual
                                               No. of        [chyph]Frequency    Total       Hours per     Total
    21 CFR Section          Form No.     [chyph]Respondents         per          Annual   [chyph]Response  Hours
                                                              [chyph]Response  Responses
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720.1 through 720.4     FDA 2512 and             54               35.6         1,920             0.5       960
 (new                    FDA 2512a
 [chyph]submission)
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720.4 and 720.6         FDA 2512 and             54                1.4            75            0.33        25
 (amendments)            FDA 2512a
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[[Page 62978]]

 
720.3 and 720.6         FDA 2514                 54                0.4            20             0.1         2
 (notices of
 [chyph]discontinuance
 )
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720.8 (requests for     0                         0                  0             0             1.5         0
 [chyph]confidentialit
 y)
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Total                                                                                                      987
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    This estimate is based on the number and frequency of submissions 
received in the past and on discussions between FDA staff and 
respondents during routine communications. The actual time required for 
each submission will vary in relation to the size of the company and 
the breadth of its marketing activities.

    Dated: October 1, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-25642 Filed 10-8-02; 8:45 am]
BILLING CODE 4160-01-S