[Federal Register Volume 61, Number 247 (Monday, December 23, 1996)]
[Notices]
[Pages 67556-67557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32426]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0457]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

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 
January 21, 1997.
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, Attention: 
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1223.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the 
Paperwork Reduction Act of 1995 (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, 
720.8(b)) (OMB Control Number 0910-0030--Reinstatement)

    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 has 
requested, under part 720 (21 CFR part 720), but does not require, that 
firms that manufacture, pack, or distribute cosmetics file an 
ingredient statement for each of their products with the agency 
(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 in 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 deleterious to humans and the public health generally. 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 the frequency of 
use.
    FDA estimates the burden of the cosmetic product for each 
submission will vary in relation to the size of the company and the 
breadth of its marketing activities. The estimated reporting burden of 
this collection of information is as follows:

                                        Estimated Annual Reporting Burden                                       
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                                                      Annual                                                    
 21 CFR Section      Form No.         No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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720.1 & 720.4     FDA 2512/2512a      550               4.2         2,310               0.50        1,155       
 (new                                                                                                           
 submissions)                                                                                                   
720.4 & 720.6     FDA 2512/2512a      550               1.4           770               0.33          254       
 (amendments)                                                                                                   
720.6 (notice of  FDA 2514            550               4.5         2,500               0.10          250       
 discontinuance)                                                                                                
                                                                                                                
720.8(b)          ..............        2               1.0             2               1.50            3       
 (request for                                                                                                   
 confidentiality                                                                                                
 )                                                                                                              
Total                                                               5,582                           1,662       
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There are no capital costs or operating and maintenance costs associated with this collection.                  


[[Page 67557]]

    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: December 12, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-32426 Filed 12-20-96; 8:45 am]
BILLING CODE 4160-01-F