[Federal Register Volume 69, Number 137 (Monday, July 19, 2004)]
[Notices]
[Pages 43001-43002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16307]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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.
[[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://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\
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Annual
21 CFR Part Form No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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710 FDA 2511 15 1 15 0.4 6
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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]
BILLING CODE 4160-01-S