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

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]

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