[Federal Register Volume 63, Number 169 (Tuesday, September 1, 1998)]
[Notices]
[Pages 46461-46462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23401]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0378]
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 (the PRA).
DATES: Submit written comments on the collection of information by
October 1, 1998.
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:
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Margaret R. 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 section 3507 of the PRA
(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
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 additive and its use are in conformity with a
regulation that describes the conditions under which the additive may
be safely used, or unless the 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 additive must be from a
batch certified by FDA to conform to the requirements of that
regulation and other applicable regulations, unless the additive has
been exempted from the certification requirement.
Section 721(c) of the act instructs the Secretary of Health and
Human Services (through FDA) to issue regulations providing for batch
certification of color additives for which she finds such requirement
to be necessary in the interest of protecting the public health. FDA's
implementing regulations in 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 requestor. 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
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
[[Page 46462]]
that all of the required information has been included. Since 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 disposition of
that batch of color additive. The batch weight serves to account for
the disposition 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden1
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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80.21 20 152 4,091 0.2 818
80.22 20 152 4,091 0.05 205
Total 1,023
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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 Burden1
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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80.39 27 152 4,091 0.25 1,023
Total 1,023
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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 2,046 hours. Over the period fiscal year (FY) 1995 to FY 1997, FDA
processed an average of 4,091 requests for certification of batches of
color additives. Approximately 20 different respondents submitted
requests for certification each year over the period FY 1995 to FY
1997. The estimates for the length of time necessary to prepare
certification requests and accompanying samples, and to comply with
recordkeeping requirements were obtained from industry program area
personnel.
Dated: August 13, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-23401 Filed 8-31-98; 8:45 am]
BILLING CODE 4160-01-F
