[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