[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
