[Federal Register Volume 66, Number 72 (Friday, April 13, 2001)]
[Notices]
[Pages 19174-19175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9120]



[[Page 19174]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-0154]


Agency Information Collection Activities; Proposed Collection; 
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 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 June 12, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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 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 set forth in this document.
    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.

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

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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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                  Annual Frequency per      Total Annual
              21 CFR Section                 No. of Respondents         Response              Responses        Hours per Response        Total Hours
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80.21                                               41                   106                 4,344                     0.2                 869
80.22                                               41                   106                 4,344                     0.05                217
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  Total                                                                                                                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.


                                                   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 Record         Total Hours
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80.39                                               41                   106                 4,344                     0.25              1,086
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  Total                                                                                                                                  1,086
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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 4,344 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: April 6, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-9120 Filed 4-12-01; 8:45 am]
BILLING CODE 4160-01-S