[Federal Register Volume 72, Number 141 (Tuesday, July 24, 2007)]
[Notices]
[Pages 40310-40311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14201]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0279]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Color Additive Certification Requests and 
Recordkeeping

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 information collection 
provisions of FDA's regulations governing batch certification of color 
additives manufactured for use in foods, drugs, cosmetics or medical 
devices in the United States.

DATES: Submit written or electronic comments on the collection of 
information by September 24, 2007.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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 set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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.

Color Additive Certification Requests and Recordkeeping--21 CFR Part 80 
(OMB Control Number 0910-0216)--Extension

    FDA has regulatory oversight for color additives used in foods, 
drugs, cosmetics, and medical devices. Section 721(a) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379e(a)) provides 
that a color additive shall be deemed to be unsafe unless it meets the 
requirements of a listing regulation, including any requirement for 
batch certification, and is used in accordance with the regulation. FDA 
lists color additives that have been shown to be safe for their 
intended uses in title 21 of the Code of Federal Regulations (CFR). FDA 
requires batch certification for all color additives listed in 21 CFR 
part 74 and for all color additives provisionally listed in 21 CFR part 
82. Color additives listed in 21 CFR part 73 are exempted from 
certification.
    The requirements for color additive certification are described in 
21 CFR part 80. In the certification procedure, a representative sample 
of a new batch of color additive, accompanied by a ``request for 
certification'' that provides information about the batch, must be 
submitted to FDA's Office of Cosmetics and Colors. FDA personnel 
perform chemical and other analyses of the representative sample and, 
providing the sample satisfies all certification requirements, issue a 
certification lot number for the batch. FDA charges a fee for 
certification based on the batch weight and requires manufacturers to 
keep records of the batch pending and after certification.
    Under Sec.  80.21, a request for certification must include: Name 
of color additive, manufacturer's batch number and weight in pounds, 
name and address of manufacturer, storage conditions, statement of 
use(s), certification fee, and signature of person requesting 
certification. Under Sec.  80.22, a request for certification must 
include a sample of the batch of color additive that is the subject of 
the request. The sample must be labeled to show: Name of color 
additive, manufacturer's batch number and quantity, and name and 
address of person requesting certification. Under Sec.  80.39, the 
person to whom a certificate is issued must keep complete records 
showing the disposal of all the color additive covered by the 
certificate. Such records are to be made available upon request to any 
accredited representative of FDA until at least 2 years after disposal 
of all of the color additive.
    The purpose for collecting this information is to help FDA assure 
that only safe color additives will be used in foods, drugs, cosmetics, 
and medical

[[Page 40311]]

devices sold in the United States. The required information is unique 
to the batch of color additive that is the subject of a request for 
certification. The manufacturer's batch number is used for temporarily 
identifying a batch of color additive until FDA issues a certification 
lot number and for identifying a certified batch during inspections. 
The manufacturer's batch number also aids in tracing the disposal of a 
certified batch or a batch that has been refused certification for 
noncompliance with the color additive regulations. The manufacturer's 
batch weight is used for assessing the certification fee. The batch 
weight also is used to account for the disposal of a batch of certified 
or certification-rejected color additive. The batch weight can be used 
in a recall to determine whether all unused color additive in the batch 
has been recalled. The manufacturer's name and address and the name and 
address of the person requesting certification are used to contact the 
person responsible should a question arise concerning compliance with 
the color additive regulations. Information on storage conditions 
pending certification is used to evaluate whether a batch of certified 
color additive is inadvertently or intentionally altered in a manner 
that would make the sample submitted for certification analysis 
unrepresentative of the batch. FDA checks storage information during 
inspections. Information on intended uses for a batch of color additive 
is used to assure that a batch of certified color additive will be used 
in accordance with the requirements of its listing regulation. The 
statement of the fee on a certification request is used for accounting 
purposes so that a person requesting certification can be notified 
promptly of any discrepancies.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
80.21                             32                174              5,568               0.20              1,114
----------------------------------------------------------------------------------------------------------------
80.22                             32                174              5,568               0.05                278
----------------------------------------------------------------------------------------------------------------
Total              .................  .................  .................               0.25             1,392
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual
  21 CFR Section     Recordkeepers     of Recordkeeping       Records       Hours per  Record     Total Hours
----------------------------------------------------------------------------------------------------------------
80.39                             32                174              5,568               0.25              1,392
----------------------------------------------------------------------------------------------------------------
Total              .................  .................  .................  .................             1,392
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA bases its estimate on its review of the certification requests 
received over the past 3 fiscal years (FY). The annual burden estimate 
for this information collection is 2,784 hours. The estimated reporting 
burden for this information collection is 1,392 hours and the estimated 
recordkeeping burden for this information collection is 1,392 hours. 
From FY 2004 to FY 2006, FDA processed an average of 5,568 responses 
(requests for certification of batches of color additives) per year. 
There were 32 different respondents, corresponding to an average of 
approximately 174 responses from each respondent per year. Using 
information from industry personnel, FDA estimates that an average of 
0.25 hour per response is required for reporting (preparing 
certification requests and accompanying sample labels) and an average 
of 0.25 hour per response is required for recordkeeping.
    On February 13, 2006, FDA introduced a Web-based Color 
Certification information system. The system was fully operational for 
FY 2007. This system allows certifiers to request color certification 
on-line, follow their submissions through the process, and obtain 
information on account status. The system sends back the certification 
results electronically, allowing certifiers to sell their certified 
color before receiving hard copy certificates. Any delays in the system 
result only from shipment of color additive samples to FDA's Office of 
Cosmetics and Colors for analysis. FDA expects future reductions in the 
hour burdens for reporting and recordkeeping from use of the Web-based 
system.

    Dated: July 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-14201 Filed 7-23-07; 8:45 am]
BILLING CODE 4160-01-S