[Federal Register Volume 64, Number 152 (Monday, August 9, 1999)]
[Notices]
[Pages 43188-43189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20359]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0185]


Agency Information Collection Activities: Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension 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 8, 1999.
ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (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 extension of a collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth 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

[[Page 43189]]

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, 
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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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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/FDA       550               4.2         2,310               0.5         1,155
 submissions)       2512a
720.6              FDA 2512/          550               1.4           770               0.33          254
 (Amendments)       2512a
720.6 (Notices of  FDA 2514           550               4.5         2,500               0.1           250
 discontinuance)
720.8 (Requests                         2               1.0             2               1.5             3
 for
 confidentiality
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: August 2, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-20359 Filed 8-6-99; 8:45 am]
BILLING CODE 4160-01-F