[Federal Register Volume 64, Number 208 (Thursday, October 28, 1999)]
[Notices]
[Pages 58069-58070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28111]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-2549]
Agency Information Collection Activities; Submission for OMB
Review; 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 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
November 29, 1999.
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 20503, Attn:
Wendy Taylor, Desk Officer for FDA.
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: In compliance with 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,
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.
In the Federal Register of August 9, 1999 (64 FR 43188), the
agency requested comments on the proposed
[[Page 58070]]
collections of information. One comment was received in support of the
continuation of the program.
Table 1.--Estimated Annual Reporting Burden
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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/ 550 4.2 2,310 0.5 1,155
submissions) FDA 2512a
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720.6 (Amendments) FDA 2512/ 550 1.4 770 0.33 254
FDA 2512a
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720.6 (Notices of FDA 2514 550 4.5 2,500 0.1 250
discontinuance)
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720.8 (Requests for 2 1.0 2 1.5 3
confidentiality)
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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: October 21, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-28111 Filed 10-27-99; 8:45 am]
BILLING CODE 4160-01-F