[Federal Register: October 11, 2005 (Volume 70, Number 195)]
[Notices]
[Page 59073-59074]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11oc05-60]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0217]
Agency Information Collection Activities; Submission for Office
of Management and Budget 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 a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 10, 2005.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that comments be faxed to the
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota,
Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (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 Part 720 (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. Ingredient statements
for new submissions (Sec. Sec. 720.1 through 720.4) are reported on
Form FDA 2512, ``Cosmetic Product Ingredient Statement,'' and on Form
FDA 2512a, a continuation form. Amendments to product formulations
(Sec. Sec. 720.3, 720.4, and 720.6) also are 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. Sec. 720.3 and 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 places cosmetic product filing information in a computer
database and uses the information for evaluation of cosmetic products
currently on the market. Because filing of cosmetic product
formulations is not mandatory, voluntary filings provide FDA with the
best information available about cosmetic product ingredients and their
frequency of use, businesses engaged in the manufacture and
distribution of cosmetics, and approximate rates of product
discontinuance and formula modifications. The information assists FDA
scientists in evaluating reports of alleged injuries and adverse
reactions from the use of cosmetics. The information also is used in
defining and planning analytical and toxicological studies pertaining
to cosmetics.
Information from the database is releasable to the public under FDA
compliance with the Freedom of Information Act. FDA shares
nonconfidential information from its files on cosmetics with consumers,
medical professionals, and industry.
FDA has developed an electronic submission system for filing Forms
FDA 2512, FDA 2512a, and FDA 2514 that will reduce the reporting burden
for respondents and FDA. The system is currently undergoing additional
beta testing and implementation is anticipated for fall 2005.
In the Federal Register of June 13, 2005 (70 FR 34142), FDA
published a 60-day notice requesting public comment on the proposed
extension of an existing collection of information described by the
regulations in part 720. FDA received two letters, one from a trade
association and one from a cosmetic company, each containing one or
more comments, in response to the proposed extension of existing
collection of information for part 720.
The trade association commended the agency for making the Cosmetic
Product Voluntary Reporting Program less burdensome on the cosmetic
industry by modernizing the program to take advantage of technological
advances. The cosmetic company stated, however, that the requirement
for both the ingredient name and a 9-digit identification number on
Form FDA 2512a is burdensome.
FDA appreciates the trade association's remarks as well its
assistance in making the voluntary reporting system more efficient. As
to the burdensomeness of the dual requirement expressed by the cosmetic
company, FDA expects to have its new system for electronic submission
of cosmetic ingredient information to the Cosmetic Product Voluntary
Reporting Program, which is currently in the beta testing stage,
implemented in fall 2005. FDA expects that the new system will greatly
simplify the submission of cosmetic ingredient information to the
program by, among other things, permitting either the identification
number or ingredient name to be submitted (except for new ingredients).
The cosmetic company also requested that FDA accept submission of a
single Form FDA 2512 for groups of hair color preparations for which
only the amounts of color additive ingredients are varied. FDA is not
granting this request as it will be unnecessary once the agency
implements its new electronic submission system. The agency's new
electronic submission system will facilitate new submissions by making
frequently used ingredients accessible from a ``favorites'' list and by
making ingredient formulations previously submitted on the paper forms
accessible to users of the new system upon proof of ownership.
The cosmetic company also requested that FDA modify the
continuation footer in the paper version of Form FDA 2512a. FDA does
not believe the requested change is necessary because the agency
expects that its new electronic submission system will greatly reduce
the use of paper versions of Forms FDA 2512, FDA 2512a, and FDA 2514.
The cosmetic company suggested that FDA revise the product
categories in Sec. 720.4(c) to include new types of products. FDA is
not making the suggested revision. The agency does not believe this
revision is necessary because each category already provides a
subcategory for ``other preparations'' that covers products that do not
fit in the specified subcategories.
Finally, the cosmetic company recommended that FDA's new electronic
submission system provide for direct transfer of information from
company databases to FDA's. FDA is not permitting this recommended
direct transfer of information for security reasons. The agency has to
limit the
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ways people can enter data into the electronic submission system to
protect the database from corruption.
FDA estimates the burden of the collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Form No. Respondents per Response Responses Response Total Hours
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720.1 through 720.4 (new FDA 2512 and FDA 2512a 112 12.9 1,446 0.5 723
submissions)
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720.4 and 720.6 (amendments) FDA 2512 and FDA 2512a 112 0.5 52 0.33 17
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720.3 and 720.6 (notices of FDA 2514 112 1 4 0.1 0.4
discontinuance)
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720.8 (requests for .............................. 1 1 1 1.5 1.5
confidentiality)
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Total 742
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates are based on FDA's experience with the Cosmetic
Product Voluntary Reporting Program. The estimated annual total hours
burden is 75 percent of the burden reported in 2002 due to decreased
submissions. However, the number of respondents doubled, and FDA
attributes this to increased interest in the program. FDA expects the
number of submissions to increase accordingly in the next 3 years.
Dated: October 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-20307 Filed 10-7-05; 8:45 am]
BILLING CODE 4160-01-S