[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
