[Federal Register Volume 72, Number 138 (Thursday, July 19, 2007)]
[Notices]
[Pages 39626-39627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14013]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0278]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in 
theFederal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the voluntary registration of 
cosmetic product establishments with FDA.

DATES: Submit written or electronic comments on the collection of 
information by September 17, 2007.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the

[[Page 39627]]

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Voluntary Registration of Cosmetic Product Establishments--21 CFR Part 
710 (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.
    FDA estimates the burden of this information collection as follows:

                                                     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 Respondent       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: July 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-14013 Filed 7-18-07; 8:45 am]
BILLING CODE 4160-01-S