[Federal Register Volume 72, Number 222 (Monday, November 19, 2007)]
[Notices]
[Pages 65041-65042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22588]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0278]


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

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 
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 [email protected]. 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.

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.

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:

[[Page 65042]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                 No. of        Annual Frequency     Total Annual        Hours per
              21 CFR Part                      Form           Respondents        per Response        Responses           Response         Total Hours
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710                                              FDA 2511                135                  1                135                0.2                 27
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\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.

    Dated: November 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-22588 Filed 11-16-07; 8:45 am]
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