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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Cosmetic Registration Program

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Food and Drug Administration, HHS.




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.


Fax written comments on the collection of information by January 15, 2009.


To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to All comments should be identified with the OMB control number 0910-0030. Also include the FDA docket number found in brackets in the heading of this document.

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Jonna Capezzuto, Office of Information Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3794.

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In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Voluntary Cosmetic Registration Program—(OMB Control Number 0910-0030)—Extension

The Federal Food, Drug, and Cosmetic Act (the act) provides FDA with the authority to regulate cosmetic products in the United States. 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) may not be distributed in interstate commerce. To assist FDA in carrying out its responsibility to regulate cosmetics, the agency has developed the Voluntary Cosmetic Registration Program (VCRP). In part 720 (21 CFR part 720), FDA requests 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 (§§ 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 (§§ 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” (§§ 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 § 720.8.

FDA's online filing system, intended to make it easier to participate in the VCRP, was made available industry-wide on December 1, 2005. The online filing system is available on FDA's VCRP Web site at​~dms/​cos-regn.html. The online filing system contains the electronic versions of Forms FDA 2512, 2512a, and 2514, which are collectively found within the electronic version of Form FDA 2512. The agency strongly encourages electronic filing of Form FDA 2512 because it is faster and more convenient. A filing facility will receive confirmation of electronic filing by e-mail. Submission of the paper version of Forms FDA 2512, 2512a, and 2514 remains an option as described in​~dms/​cos-reg2.html. However, due to the high volume of online participation, the VCRP is allocating its limited resources primarily to electronic filings.

FDA places cosmetic product filing information in a computer data base 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.

In the Federal Register of September 17, 2008 (73 FR 53877), FDA published a 60-day notice requesting public comment on the information collection Start Printed Page 76361provisions. FDA received two letters in response to the notice, each containing one or more comments. One comment suggested that FDA make the voluntary cosmetic registration program mandatory. FDA responds that it has no statutory authority to require mandatory cosmetic product reporting. The remaining comments received were not responsive to the comment request on the four specified aspects of the collection of information. These non-responsive comments will not be addressed in this document.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden1

21 CFR SectionForm No.No. of RespondentsAnnual Frequency per ResponseTotal Annual ResponsesHours per ResponseTotal Hours
720.1 through 720.4 (new submissions)FDA 25122141314,371.331,442
720.4 and 720.6 (amendments)FDA 25121097763.17130
720.3, 720.6 (notices of discontinuance)FDA 251255412,255.1226
720.8 (requests for confidentiality)1111.51.5
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 The term “Form FDA 2512” refers to both the paper Forms FDA 2512, 2512a, and 2514 and electronic Form FDA 2512 in the electronic system known as the Voluntary Cosmetic Registration Program, which is available at​~dms/​cos-regn.html.

The estimated number of respondents is based on submissions received from fiscal years 2005 to 2007. The estimated time required for each submission is based upon information from cosmetic industry personnel and FDA experience entering data submitted on paper Forms FDA 2512, 2512a, and 2514. The increase in total annual responses is due to increased participation by cosmetic companies, because of a renewed industry commitment to the program, and implementation of the online filing system on December 1, 2005. The decrease in hours per response is due to the ease of online filing.

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Dated: December 9, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

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[FR Doc. E8-29685 Filed 12-15-08; 8:45 am]