2016-04228. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Additive Petitions and Investigational Food Additive Exemptions

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 March 30, 2016.

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], or emailed to [e-mail]. All comments should be identified with the OMB control number 0910-0546. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [e-mail].

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.

Food Additive Petitions and Investigational Food Additive Exemptions, 21 CFR 570.17 and 571 OMB Control Number 0910-0546—Extension

Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed to be unsafe unless its use is permitted by a regulation which prescribes the condition(s) under which it may safely be used, or unless it is exempted by regulation for investigational use. Section 409(b) of the FD&C Act specifies the information that must be submitted by a petitioner in order to establish the safety of a food additive and to secure the issuance of a regulation permitting its use.

To implement the provisions of section 409 of the FD&C Act, procedural regulations have been issued under 21 CFR part 571. These procedural regulations are designed to specify more thoroughly the information that must be submitted to meet the requirement set down in broader terms by the FD&C Act. The regulations add no substantive requirements to those indicated in the FD&C Act, but attempt to explain these requirements and provide a standard format for submission to speed processing of the petition. Labeling requirements for food additives intended for animal consumption are also set forth in various regulations contained in parts 501, 573, and 579. The labeling regulations are considered by FDA to be cross-referenced to § 571.1, which is the subject of this same OMB clearance for food additive petitions.

With regard to the investigational use of food additives, section 409(j) of the FD&C Act provides that any food additive, or any food bearing or containing such an additive, may be exempted from the requirements of this section if intended solely for investigational use by qualified experts. Investigational use of a food additive is typically to address the safety and/or intended physical or technical effect of the additive.

To implement the provisions of section 409(j), regulations have been issued under 21 CFR 570.17. These regulations are designed to specify more thoroughly the information that must be submitted to meet the requirement set down in broad terms by the FD&C Act. Labeling requirements for investigational food additives are also set forth in various regulations contained in part 501. The labeling regulations are considered by FDA to be cross-referenced to § 570.17, which is the subject of this same OMB clearance for investigational food additive files.

In the Federal Register of October 21, 2015 (80 FR 63795), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

We estimate the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden ¹ Food Additive Petitions

21 CFR section	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
571.1(c) Moderate Category	12	1	12	3,000	36,000
571.1(c) Complex Category	12	1	12	10,000	120,000
571.6 Amendment of Petition	2	1	2	1,300	2,600
Total Hours					158,600
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

We base our estimate of the total annual responses on submissions received during fiscal years 2014 and 2015. We base our estimate of the hours per response upon our experience with the petition and filing processes.

571.1(c) moderate category: For a food additive petition without complex chemistry, manufacturing, efficacy, or safety issues, the estimated time requirement per petition is approximately 3,000 hours. We estimate that, annually, 12 respondents will each submit 1 such petition, for a total of 36,000 hours.

571.1(c) complex category: For a food additive petition with complex chemistry, manufacturing, efficacy, and/or safety issues, the estimated time requirement per petition is approximately 10,000 hours. We estimate that, annually, 12 respondents will each submit 1 such petition, for a total of 120,000 hours.

571.6: For a food additive petition amendment, the estimated time requirement per petition is approximately 1,300 hours. We estimate that, annually, 2 respondents will each submit 1 such amendment, for a total of 2,600 hours.

Table 2—Estimated Annual Reporting Burden ¹ Investigational Food Additive Files

21 CFR section	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
570.17 Moderate Category	4	1	4	1,500	6,000
570.17 Complex Category	5	1	5	5,000	25,000
Total Hours					31,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

570.17 moderate category: For an investigational food additive file without complex chemistry, manufacturing, efficacy, or safety issues, the estimated time requirement per file is approximately 1,500 hours. We estimate that, annually, 4 respondents will each submit 1 such file, for a total of 6,000 hours.

570.17 complex category: For an investigational food additive file with complex chemistry, manufacturing, efficacy, and/or safety issues, the estimated time requirement per file is approximately 5,000 hours. We estimate that, annually, 5 respondents will each submit 1 such file, for a total of 25,000 hours.

Dated: February 23, 2016.

Leslie Kux,

Associate Commissioner for Policy.