[Federal Register Volume 66, Number 126 (Friday, June 29, 2001)]
[Notices]
[Page 34685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16324]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0153]


Agency Information Collection Activities; Submission for OMB 
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 the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by July 
30, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (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.

Voluntary Registration of Cosmetic Product Establishments--21 CFR 
Part 710 (OMB Control Number 0910-0027)--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) may not 
be distributed in interstate commerce. To assist FDA in carrying out 
its responsibility to regulate cosmetics, FDA requests that 
establishments that manufacture or package cosmetic products register 
with the agency on Form FDA 2511 entitled ``Registration of Cosmetic 
Product Establishment.'' Regulations providing procedures for the 
voluntary registration of cosmetic product establishments are found in 
21 CFR part 710.
    Since mandatory registration of cosmetic establishments is not 
authorized by statute, voluntary registration provides FDA with the 
best information available about the location, business trade names 
used, and the type of activity (manufacturing or packaging) of cosmetic 
product establishments that participate in this program. In addition, 
the registration information is an essential part of planning onsite 
inspections to determine the scope and extent of noncompliance with 
applicable provisions of the act. The registration information is used 
to estimate the size of the cosmetic industry regulated. Registration 
is permanent, although FDA requests that firms submit an amended 
registration on Form FDA 2511 if any of the information originally 
submitted changes.
    FDA uses registration information as input for a computer data base 
of cosmetic product establishments. This database is used for mailing 
lists to distribute regulatory information or to invite firms to 
participate in workshops on topics in which they may be interested.
    In the Federal Register of April 13, 2001 (66 FR 19175), the agency 
requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                           Annual Frequency      Total Annual
       21 CFR Part                    Form            No. of Respondents     per Response          Responses      Hours per Response      Total Hours
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710                        FDA 2511                          50                   1                  50                   0.4                20
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burden estimates are based on past experience and on 
discussions with registrants during routine communications. FDA 
receives an average of 50 registration submissions annually. There has 
been no change over the past 16 years in the number of submissions of 
Form FDA 2511 or in the time it takes to complete this form.

    Dated: June 22, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-16324 Filed 6-28-01; 8:45 am]
BILLING CODE 4160-01-S