Federal Register, Volume 63 Issue 146 (Thursday, July 30, 1998)

[Federal Register Volume 63, Number 146 (Thursday, July 30, 1998)]
[Notices]
[Pages 40718-40719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20302]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0194]

Agency Information Collection Activities; Submission for OMB
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 (the PRA).

DATES: Submit written comments on the collection of information by
August 31, 1998.

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:
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Margaret R. 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 section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance.

Registration of Cosmetic Product Establishment--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 trading 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 data base 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. FDA
estimates the burden of this collection of information as follows:

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

[[Page 40719]]

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 13 years in the number of submissions of
Form FDA 2511 or in the time it takes to complete this form.

Dated: July 23, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-20302 Filed 7-29-98; 8:45 am]
BILLING CODE 4160-01-F}