[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