[Federal Register: July 19, 2004 (Volume 69, Number 137)]
[Notices]               
[Page 42998-42999]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19jy04-76]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0062]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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.

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.

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 
part 80 (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

[[Page 42999]]

only safe color additives will be used in foods, drugs, cosmetics, and 
medical 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.
    In the Federal Register of February 26, 2004 (69 FR 8977), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
----------------------------------------------------------------------------------------------------------------
80.21                                         23             200           4,603            0.20             921
----------------------------------------------------------------------------------------------------------------
80.22                                         23             200           4,603            0.05             230
----------------------------------------------------------------------------------------------------------------
Total                                                                                       0.25           1,151
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       Frequency of    Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records         Record
----------------------------------------------------------------------------------------------------------------
80.39                                         23             200           4,603            0.25           1,151
----------------------------------------------------------------------------------------------------------------
Total                                                                                                      1,151
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The annual burden estimate for this information collection is 2,302 
hours. The estimated reporting burden for this information collection 
is 1,151 hours and the estimated recordkeeping burden for this 
information collection is 1,151 hours. From fiscal years 2001 to 2003, 
FDA processed an average of 4,603 responses (requests for certification 
of batches of color additives) per year. There were 23 different 
respondents, corresponding to an average of approximately 200 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.

    Dated: July 13, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-16304 Filed 7-16-04; 8:45 am]

BILLING CODE 4160-01-S