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Notice

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

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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 December 19, 2007.

ADDRESSES:

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 baguilar@omb.eop.gov. All comments should be identified with the OMB control number 0910-0027. Also include the FDA docket number found in brackets in the heading of this document.

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FOR FURTHER INFORMATION CONTACT:

Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

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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.

Voluntary Registration of Cosmetic Product Establishments—(OMB Control Number 0910-0027)—Extension

The Federal Food, Drug, and Cosmetic Act (the act) provides FDA with the responsibility for assuring consumers that cosmetic products in the United States are safe and properly labeled. 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, FDA has developed the Voluntary Cosmetic Registration Program (VCRP). In 21 CFR part 710, FDA requests that establishments that manufacture or package cosmetic products register with the agency on Form FDA 2511 entitled “Registration of Cosmetic Product Establishment.” The term “Form FDA 2511” refers to both the paper and electronic versions of the form. The electronic version of Form FDA 2511 is available on FDA's VCRP Web site at http://www.cfsan.fda.gov/​~dms/​cos-regn.html. FDA's online registration system, intended to make it easier to participate in the VCRP, was made available industry-wide on December 1, 2005. The agency strongly encourages electronic registration of Form FDA 2511 because it is faster and more convenient. A registering facility will receive confirmation of electronic registration, including a registration number, by e-mail, usually within 7 business days. The online system also allows for amendments to past submissions. Submission of the paper version of Form FDA 2511 remains an option as described in http://www.cfsan.fda.gov/​~dms/​cos-reg2.html. However, due to the high volume of online participation, the VCRP is allocating its limited resources primarily to electronic registrations.

Because registration of cosmetic product establishments is not mandatory, voluntary registration provides FDA with the best information available about the locations, business trade names, and types of activity (manufacturing or packaging) of cosmetic product establishments. FDA places the registration information in a computer database and uses the information to generate mailing lists for distributing regulatory information and for inviting firms to participate in workshops on topics in which they may be interested. FDA also uses the information for estimating the size of the cosmetic industry and for conducting onsite establishment inspections. Registration is permanent, although FDA requests that respondents submit an amended Form FDA 2511 if any of the originally submitted information changes.

In the Federal Register of July 19, 2007 (72 FR 39626), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

FDA estimates the burden of this information collection as follows:Start Printed Page 65042

Table 1.—Estimated Annual Reporting Burden1

21 CFR PartFormNo. of RespondentsAnnual Frequency per ResponseTotal Annual ResponsesHours per ResponseTotal Hours
710FDA 251113511350.227
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA bases its estimate on its review of the registrations received over the past 3 fiscal years. The total annual responses (averaged over fiscal years 2004 through 2006) is 9 times the previous total reported in 2004 (for fiscal years 2000 through 2003) due to increased participation by cosmetic companies, because of a renewed industry commitment to the program, and implementation of the online registration system on December 1, 2005. Due to the ease of online registration, FDA estimates that the hours per response have declined from 0.4 hours to 0.2 hours. Thus, the total estimated hour burden for this information collection is 27 hours, which is 4.5 times the previous level reported in 2004.

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Dated: November 13, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E7-22588 Filed 11-16-07; 8:45 am]

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