E7-7813. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Fax written comments on the collection of information by May 25, 2007.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: [phone]. All comments should be identified with the OMB control number 0910-0016. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; Electronic Submission Using Food and Drug Administration Forms 3503 and 3504 (OMB Control Number 0910-0016)—Extension

Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed to be unsafe, unless: (1) The additive and its use, or intended use, are in conformity with a regulation issued under section 409 of the act that describes the condition(s) under which the additive may be safely used; (2) the additive and its use, or intended use, conform to the terms of an exemption for investigational use; or (3) a food contact notification submitted under section 409(h) of the act is effective. Food additive petitions (FAPs) are submitted by individuals or companies to obtain approval of a new food additive or to amend the conditions of use permitted under an existing food additive regulation. Section 171.1 (21 CFR 171.1) specifies the information that a petitioner must submit in order to establish that the proposed use of a food additive is safe and to secure the publication of a food additive regulation describing the conditions under which the additive may be safely used. Parts 172, 173, 179, and 180 (21 CFR parts 172, 173, 179, and 180) contain labeling requirements for certain food additives to ensure their safe use.

Section 721(a) of the act (21 U.S.C. 379e(a)) provides that a color additive shall be deemed to be unsafe unless the additive and its use are in conformity with a regulation that describes the condition(s) under which the additive may safely be used, or the additive and its use conform to the terms of an exemption for investigational use issued under section 721(f) of the act. Color additive petitions (CAPs) are submitted by individuals or companies to obtain approval of a new color additive or a change in the conditions of use permitted for a color additive that is already approved. Section 71.1 (21 CFR 71.1) specifies the information that a petitioner must submit to establish the safety of a color additive and to secure the issuance of a regulation permitting its use. FDA's color additive labeling requirements in § 70.25 (21 CFR 70.25) require that color additives that are to be used in food, drugs, devices, or cosmetics be labeled with sufficient information to ensure their safe use.

Under section 201(s) of the act (21 U.S.C. 321(s)), a substance is generally recognized as safe (GRAS) if it is generally recognized among experts qualified by scientific training and experience to evaluate its safety, to be safe through either scientific procedures or common use in food.

The act historically has been interpreted to permit food manufacturers to make their own initial determination that use of a substance in food is GRAS and thereafter seek affirmation of GRAS status from FDA. FDA reviews petitions for affirmation of GRAS status that are submitted on a voluntary basis by the food industry and other interested parties under authority of sections 201, 402, 409, and 701 of the act (21 U.S.C. 342, 348, and 371). To implement the GRAS provisions of the act, FDA has set forth procedures for the GRAS affirmation petition process in § 170.35(c)(1) (21 CFR 170.35(c)(1)). While the GRAS affirmation petition process still exists, FDA has not received a GRAS affirmation petition since the establishment of the voluntary GRAS notification program.

In the Federal Register of July 31, 2001 (66 FR 39517), FDA announced the availability of a draft guidance entitled “Draft Guidance for Industry on Providing Regulatory Submissions to Office of Food Additive Safety in Electronic Format for Food Additive and Color Additive Petitions.” This guidance describes the procedures for electronic submission of FAPs and CAPs using FDA Form 3503 and FDA Form 3504, respectively.

FDA scientific personnel review food and color additive and GRAS affirmation petitions to ensure the safety of the intended use of the substance in or on food, or of a food additive that may be present in food as a result of its use in articles that contact food (or for color additives, its use in food, drugs, cosmetics, or medical devices).

Description of respondents: Respondents are businesses engaged in the manufacture or sale of food, food ingredients, color additives, or substances used in materials that come into contact with food.

In the Federal Register of January 19, 2007 (72 FR 2533), FDA published a 60-day notice requesting public comment on the information collection provisions. FDA received one comment that was outside the scope of the request for comments.

Table 1.—Estimated Annual Reporting Burden¹

21 CFR Section/FDA Form	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Operating & Maintenance Costs	Total Hours
CAPs
70.25, 71.1	3	1	3	1,337	$8,200	4,010
FDA Form 3504	1	1	1	1	0	1
GRAS Affirmation Petitions
170.35	1 or fewer	1	1 or fewer	2,614	0	2,614
FAPs
171.1	6	1	6	7,093	0	42,560
FDA Form 3503	1	1	1	1	0	1
Total					$8,200	49,186
1 There are no capital costs associated with this collection of information.

The estimate of burden for food additive, color additive, or GRAS affirmation petitions is based on FDA's experience and the average number of new petitions received in calendar years 2003, 2004, and 2005, and the total hours expended in preparing the petitions. In compiling these estimates, FDA consulted its records of the number of petitions received in the past 3 years. The figures for hours per response are based on estimates from experienced persons in the agency and in industry. Although the estimated hour burden varies with the type of petition submitted, an average petition involves analytical work and appropriate toxicological studies, as well as the work of drafting the petition itself. The burden varies depending on the complexity of the petition, including the amount and types of data needed for scientific analysis.

Color additives are subjected to payment of fees for the petitioning process. The listing fee for a color additive petition ranges from $1,600 to $3,000, depending on the intended use of the color and the scope of the requested amendment. A complete schedule of fees is set forth in 21 CFR 70.19. An average of two category A and one category B color additive petitions are expected per year. The maximum color additive petition fee for a category A petition is $2,600 and the maximum color additive petition fee for a category B petition is $3,000. Since an average of 3 color additive petitions are expected per calendar year, the estimated total annual cost burden to petitioners for this start-up cost would be less than or equal to $8,200 ((2 x $2,600) + (1 x $3,000) = $8,200)). There are no capital costs associated with color additive petitions.

The estimated burden reported in table 1 of this document does not include the previously estimated burden for the preparation of FAPs submitted to amend parts 175 through 178 (21 CFR parts 175 through 178). The burden to respondents is similar between the preparation of petitions submitted to amend parts 175 through 178 and the preparation of a food contact substance notification. In this request for extension of OMB approval for the collection of information for FAPs, FDA proposes to transfer the collection of information and burden associated with petitions submitted to amend the indirect food additive regulations (parts 175 through 178) from this collection of information (OMB control number 0910-0016) to the existing collection of information for the Food Contact Substances Notification System (OMB control number 0910-0495).

FDA estimates the annual reporting burden associated with petitions submitted to amend parts 175 through 178 to be transferred from OMB control number 0910-0016 to OMB control number 0910-0495. An average of two indirect food additive petitions are expected per calendar year. The estimated total annual hour burden to petitioners per petition is 10,995 hours, for a total burden of 21,990 hours. There are no capital costs or operating and maintenance costs associated with the burden hours being transferred from OMB control number 0910-0016 to OMB control number 0910-0495.

Electronic submissions of petitions contain the same petition information required for paper submissions. The agency estimates that one petitioner for both food and color additives will take advantage of the electronic submission process per year. By using the guidelines and forms that FDA is providing, the petitioner will be able to organize the petition to focus on the information needed for FDA's safety review. Therefore, we estimate that petitioners will only need to spend approximately 1 hour completing the electronic submission application form (Form 3503 or 3504, as appropriate) because they will have already used the guidelines to organize the petition information needed for the submission.

The labeling requirements for food and color additives were designed to specify the minimum information needed for labeling in order that food and color manufacturers may comply with all applicable provisions of the act and other specific labeling acts administered by FDA. Label information does not require any additional information gathering beyond what is already required to assure conformance with all specifications and limitations in any given food or color additive regulation. Label information does not have any specific recordkeeping requirements unique to preparing the label. Therefore, because under § 70.25, labeling requirements for a particular color additive involve information required as part of the CAP safety review process, the estimate for number of respondents is the same for §§ 70.25 and 71.1, and the burden hours for labeling are included in the estimate for § 71.1. Also, because labeling requirements under parts 172, 173, 179, and 180 for particular food additives involve information required as part of the FAP safety review process under § 171.1, the burden hours for labeling are included in the estimate for § 171.1.

In cases where a regulation implements a statutory information collection requirement, only the additional burden attributable to the regulation, if any, has been included in FDA's burden estimate.

Dated: April 18, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.