[Federal Register: October 11, 2005 (Volume 70, Number 195)]
[Page 59073-59074]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 59073]]



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.


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

[[Page 59074]]

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 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                                          No. of       Annual Frequency     Total Annual      Hours per
           21 CFR Section                       Form No.               Respondents       per Response        Responses        Response      Total Hours
720.1 through 720.4 (new             FDA 2512 and FDA 2512a                      112                12.9            1,446            0.5           723
720.4 and 720.6 (amendments)         FDA 2512 and FDA 2512a                      112                 0.5               52            0.33           17
720.3 and 720.6 (notices of          FDA 2514                                    112                   1                4            0.1             0.4
720.8 (requests for                  ..............................                1                   1                1            1.5             1.5
Total                                                                                                                                              742
\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]