[Federal Register: February 26, 2004 (Volume 69, Number 38)]
[Notices]               
[Page 8977-8978]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26fe04-91]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0062]

 
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 April 26, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: Peggy Robbins, Office of Management 
Programs (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 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 
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

[[Page 8978]]

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 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Annual Frequency per
    21 CFR Section         No. of Respondents             Response           Total Annual Responses      Hours per Response            Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 Frequency per
    21 CFR Section        No. of Recordkeepers          Recordkeeping         Total Annual Records        Hours per Record             Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 year (FY) 2001 to FY 
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: February 19, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-4247 Filed 2-25-04; 8:45 am]

BILLING CODE 4160-01-S