[Federal Register Volume 64, Number 208 (Thursday, October 28, 1999)]
[Notices]
[Pages 58069-58070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28111]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-2549]


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 listed below 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 29, 1999.
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: 
Wendy Taylor, 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(b) (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. 720.1) are reported on 
Form FDA 2512 entitled ``Cosmetic Product Ingredient Statement,'' and 
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 entitled ``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 data base also lists 
cosmetic products containing ingredients suspected to be carcinogenic 
or otherwise harmful to the general 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 because of a lack of funding and was 
reinstated at the beginning of FY 1999. Participation returned to the 
previous level. Thus, FDA estimates that the burden of this collection 
of information will remain the same as the estimate presently on file 
with OMB.
     In the Federal Register of August 9, 1999 (64 FR 43188), the 
agency requested comments on the proposed

[[Page 58070]]

collections of information. One comment was received in support of the 
continuation of the program.

                                   Table 1.--Estimated Annual Reporting Burden
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                                                      Annual
   21 CFR Section        Form         No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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720.4 (New             FDA 2512/      550               4.2         2,310               0.5         1,155
 submissions)          FDA 2512a
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720.6 (Amendments)     FDA 2512/      550               1.4           770               0.33          254
                       FDA 2512a
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720.6 (Notices of       FDA 2514      550               4.5         2,500               0.1           250
 discontinuance)
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720.8 (Requests for                     2               1.0             2               1.5             3
 confidentiality)
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Total                                                                                               1,662
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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 21, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-28111 Filed 10-27-99; 8:45 am]
BILLING CODE 4160-01-F