[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