[Federal Register Volume 63, Number 96 (Tuesday, May 19, 1998)]
[Notices]
[Pages 27581-27582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13228]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0194]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

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 comments on the collection of information by July 
20, 1998.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

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: 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 listed below.
    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, and 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 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 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/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 
person

[[Page 27582]]

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. 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 assure 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 which the person seeking 
certification proposes that the color be certified for it is to assure 
that all of the proposed uses are within the limits of the listing 
regulation. 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 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<SUP>1                                  
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
80.21                                  20             152           4,091               0.2           818       
80.22                                  20             152           4,091               0.05          205       
Total                                                                                               1,023       
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  


                                Table 2.--Estimated Annual Recordkeeping Burden<SUP>1                                
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
----------------------------------------------------------------------------------------------------------------
80.39                                  27             152           4,091                .25        1,023       
Total                                                                                               1,023       
----------------------------------------------------------------------------------------------------------------
\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 additive. 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: May 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-13228 Filed 5-18-98; 8:45 am]
BILLING CODE 4160-01-F