[Federal Register: July 19, 2004 (Volume 69, Number 137)]
[Page 43001-43002]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0063]

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.


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.

[[Page 43002]]

DATES:  Fax written comments on the collection of information by August 
18, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, 
Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Peggy Robbins, Office of Management 
Programs (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

    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.'' Form FDA 2511 is available on FDA's 
VCRP Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/acrobat/frm2511.pdf.

    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 February 27, 2004 (69 FR 9339), 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:

                                 Table 1.--Estimated Annual Reporting Burden\1\
   21 CFR Part         Form           No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
710                     FDA 2511              15               1              15             0.4               6
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    The VCRP was suspended during fiscal year (FY) 1998 due to a lack 
of budgetary funding and was reinstated at the beginning of FY 1999. 
The estimated hour burden for this information collection is 30 percent 
of the previous level reported in 2000. In general, the larger cosmetic 
companies have resumed participating in the VCRP, whereas the smaller 
companies are lagging.

    Dated: July 13, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-16307 Filed 7-16-04; 8:45 am]