[Federal Register Volume 61, Number 169 (Thursday, August 29, 1996)]
[Notices]
[Pages 45431-45432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22121]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0185]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Reinstatement

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995, 
Federal agencies are required to publish notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed reinstatement of an existing collection of information, and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on the Cosmetic Product Voluntary Reporting Program.

DATES: Submit written comments on the collection of information by 
October 28, 1996.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Charity B. Smith, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1686.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)) requires Federal 
agencies to provide a 60-day notice in the Federal Register concerning 
each proposed collection of information, including each proposed 
reinstatement of an existing collection of information. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c). To 
comply with this requirement, FDA is publishing notice of the proposed 
collection of information listed below.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.


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 requests, 
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, ``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, ``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 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

[[Page 45432]]

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.
    FDA estimates the burden of the Cosmetic Product Voluntary 
Reporting Program as follows:

                                        Estimated Annual Reporting Burden                                       
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                                                      Annual                                                    
  21 CFR Section      Form No.        No. of       Frequency per   Total Annual      Hours per     Burden Hours 
                                    Respondents      Response        Responses       Response                   
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720.1 & 720.4      FDA 2512/          550               4.2         2,310               0.50        1,155       
 (new               2512a                                                                                       
 submissions)                                                                                                   
720.4 & 720.6      FDA 2512/          550               1.4           770               0.33          254       
 (amendments)       2512a                                                                                       
720.6 (notice of   FDA 2514           550               4.5         2,500               0.1           250       
 discontinuance)                                                                                                
720.8 (request     .............        2               1.0             2               1.5             3       
 for                                                                                                            
 confidentiality)                                                                                               
Total                                                                                               1,662       
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There are no capital costs or operating and maintenance costs associated with this collection.                  

    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: August 21, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-22121 Filed 8-28-96; 8:45 am]
BILLING CODE 4160-01-F