[Federal Register Volume 66, Number 126 (Friday, June 29, 2001)]
[Notices]
[Pages 34685-34687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16325]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0154]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Color Additive Certification Requests and 
Recordkeeping

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by July 
30, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (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

[[Page 34686]]

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 No. 0910-0216)--Extension

    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 
unsafe unless the color additive and its use are in conformity with a 
regulation that describes the conditions under which the color additive 
may be safely used, or unless the color additive and its use conform to 
the terms of an exemption for investigational use. If a regulation 
prescribing safe conditions of use has been issued, the color additive 
must be from a batch certified by FDA to conform to the requirements of 
that regulation and other applicable regulations, unless the color 
additive has been exempted from the certification requirement.
    Section 721(c) of the act instructs the Secretary of Health and 
Human Services (the Secretary) (through FDA) to issue regulations 
providing for batch certification of color additives for which the 
Secretary finds such requirement to be necessary in the interest of 
protecting the public health. FDA's implementing regulations in part 80 
(21 CFR part 80) specify the information that must accompany a request 
for certification of a batch of color additive and require certain 
records to be kept pending and after certification. 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 exempt from certification.
    Under Sec. 80.21, a request for certification must include: Name of 
color additive, batch number and weight in pounds, name and address of 
manufacturer, storage conditions, statement of use(s), fee, and 
signature of requester. The request for certification must also include 
a sample of the batch of color additive that is the subject of the 
request. Under Sec. 80.22, the sample must be labeled to show: Name of 
color additive, batch number and quantity, and name and address of the 
person requesting certification. A copy of the label or labeling to be 
used for the batch must accompany the sample. 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 request for certification of a batch of color additive is 
reviewed by FDA's Office of Cosmetics and Colors to verify that all of 
the required information has been included. Because the information 
required in the request for certification is unique to the specific 
batch of color additive involved, it must be generated for each batch. 
The information submitted with the request helps FDA to ensure that 
only safe color additives will be used in foods, drugs, cosmetics, and 
medical devices sold in the United States. The batch number assigned by 
the manufacturer is a means of temporary identification until a 
certification lot number has been issued by FDA. After certification, 
the manufacturer's batch number helps ensure that the proper batch of 
color is indeed being used under the certification lot number issued by 
FDA. In the case of a batch that has been refused certification for 
noncompliance with the regulations, the manufacturer's batch number 
aids in tracing the ultimate disposal of that batch of color additive. 
The batch weight serves to account for the disposal of the entire 
batch. For example, it might be used in determining whether uncertified 
color has been sold under the lot number assigned to the batch by FDA 
or, in the event of a recall after certification, to determine whether 
all unused color has been recalled. In addition, the batch weight is 
the basis for assessing the certification fee. The name and address of 
the manufacturer of the color additive being submitted for 
certification allows FDA to contact the person responsible for its 
manufacture should a question arise concerning compliance with the 
regulations. Information on storage conditions pending certification is 
used to evaluate the possibility that the batch could have been 
inadvertently or intentionally altered in a manner that would make the 
sample submitted for certification analysis no longer representative of 
the batch. It is also used when an FDA investigator is sent to the 
site; the veracity of the storage statements is checked during normal 
plant inspections. Information on the uses is needed to ensure that all 
of the proposed uses are within the limits of the listing regulation 
for which the person seeking certification proposes that the color be 
certified. The statement of the fee on the certification request is for 
accounting purposes so that the person seeking certification can be 
promptly notified if any discrepancies appear. The information 
requested on the label of the sample submitted with the certification 
request is used to identify the sample. The regulations require an 
accompanying copy of the label or labeling to be used for the batch so 
that FDA can verify that the batch will be labeled appropriately when 
it enters commerce.
    In the Federal Register of April 13, 2001 (66 FR 19174), the agency 
requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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    21 CFR Section        No. of Respondents     Annual Frequency per Response     Total Annual Responses     Hours per Response        Total Hours
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             80.21                       41                             106                      4,346\2\             0.2                 869
             80.22                       41                             106                      4,346\2\             0.05                217
                                                                                                                                 -----------------------
  Total..............                                                                                                                   1,086
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Due to a clerical error, the total annual records that appeared in tables 1 and 2 in the Federal Register notice of April 13, 2001 (66 FR 19175),
  was incorrect. Tables 1 and 2 of this document contains the correct total.


[[Page 34687]]


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                   Annual Frequency per
   21 CFR Section      No. of Recordkeepers           Recordkeeping              Total Annual Records        Hours per Recordkeeper       Total Hours
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             80.39                      41                            106                     4,346\2\                         0.25              1,086
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Due to a clerical error, the total annual records that appeared in tables 1 and 2 in the Federal Register notice of April 13, 2001 (66 FR 19175),
  was incorrect. Tables 1 and 2 of this document contains the correct total.

    The estimated total annual burden for this information collection 
is 2,172 hours. Over the period fiscal year (FY) 1998 to 2000, FDA 
processed an average of 4,346 requests for certification of batches of 
color additives. Approximately 41 different respondents submitted 
requests for certification each year over the period FY 1998 to 2000. 
FDA obtained the estimates for the length of time necessary to prepare 
certification requests and accompanying samples and to comply with 
recordkeeping requirements from industry program area personnel.

    Dated: June 22, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-16325 Filed 6-28-01; 8:45 am]
BILLING CODE 4160-01-S