[Federal Register Volume 63, Number 76 (Tuesday, April 21, 1998)]
[Notices]
[Pages 19734-19735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-10405]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0194]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 the
Federal 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 comments on the collection of information by June
22, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
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: 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 listed below.
With respect to the following collection of information, FDA
invites comments on: (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.
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 ``Registration of Cosmetic Product
Establishment.'' Regulations providing procedures for the voluntary
registration of cosmetic product establishments are found in 21 CFR
part 710.
Because 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 they may be interested in.
[[Page 19735]]
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
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.
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: April 14, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-10405 Filed 4-20-98; 8:45 am]
BILLING CODE 4160-01-F
