0342 Supporting Statement 2016

Substances Generally Recognized as Safe (GRAS) Notification Procedures
OMB Control No. 0910-0342
SUPPORTING STATEMENT
Terms of Clearance: In accordance with the terms of 5 CFR 1320, this ICR is approved for a
period of three years. OMB notes that the Supporting Statement claims that the new form will be
more efficient than the existing form, but it does not calculate a reduction in the burden on the
public or a reduction in Agency processing time. Please examine this as the form is in use and
consider updating these figures, as appropriate, when resubmitting to OMB.
Response: Because FDA is undertaking rulemaking that will affect the information collection, for
purposes of this extension request we are retaining our current estimates. Upon finalizing our
GRAS notification procedures we will revise the information collection accordingly.
A. Justification
1. Circumstances Making the Collection of Information Necessary
Section 409 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348) establishes
a premarket approval requirement for “food additives”; section 201(s) of the FD&C Act (21 U.S.C.
321) provides an exclusion to the definition of “food additive,” and thus from the premarket
approval requirement, for uses of substances that are GRAS by qualified experts. In the Federal
Register of April 17, 1997 (62 FR 18938), FDA published a proposed rule that would establish a
voluntary procedure whereby manufacturers would notify us about a view of a particular use (or
uses) of a substance not subject to the statutory premarket approval requirements based on a
determination that such use is GRAS. Under an interim policy announced in the proposed rule, we
invited manufacturers to submit notices of their independent determinations for review under the
framework of the proposed rule during the period between issuance of the proposal and any final
rule based on the proposal. The proposed regulations (proposed 21 CFR 170.36 and 21 CFR
570.36) provide a standard format for the voluntary submission of a notice. The notice would
include a detailed summary of the data and information that support the GRAS determination, and
the notifier would maintain a record of such data and information. FDA would make the
information describing the subject of the GRAS notice, and the agency's response to the notice,
available in a publicly accessible file; the entire GRAS notice would be publicly available
consistent with the Freedom of Information Act (FOIA) and other Federal disclosure statutes.
While FDA is currently undertaking rulemaking to finalize the proposed rule, we are requesting an
extension of the currently approved provisions of the information collection, including FDA Form
3667 entitled “Generally Recognized as Safe (GRAS) Notice.” The form is available on the
internet at:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM350015.pdf. The
form, and elements prepared as attachments to the form, may be submitted in electronic format via
the Electronic Submission Gateway (ESG), or may be submitted in paper format, or as electronic
files on physical media with paper signature page. For submissions to FDA’s Center for Veterinary
Medicine (CVM), respondents may continue to send GRAS notices in letter format to the agency, as
instructed in the Federal Register notice of June 4, 2010 (75 FR 31800).
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2. Purpose and Use of the Information Collection
Form FDA 3667 along with the GRAS notification procedures set forth in proposed §§ 170.36 and
570.36 describe the information that FDA considers important in evaluating whether a notice
provides a sufficient basis for a GRAS determination and facilitates FDA review. The information
is used to evaluate whether the notice provides a sufficient basis for a conclusion of GRAS status
and to determine whether information in the notice or otherwise available to FDA raises issues of
public health significance that would lead the agency to question whether use of the substance is
GRAS.
Description of Respondents: The respondents to this collection of information are manufacturers of
substances used in food and feed. Respondents are from the private sector (for-profit businesses).
3. Use of Improved Information Technology and Burden Reduction
Form FDA 3667 allows respondents to transmit GRAS notices to CFSAN. GRAS notices
submitted to CVM continue to be in letter format. Therefore, the agency estimates that
approximately 70% of submissions will be made electronically, while 30% will continue to be
submitted in letter format as established under the current procedures.
4. Efforts to Identify Duplication and Use of Similar Information
Duplication of the information collection is unlikely. Under the Meat and Poultry Inspection Acts,
the United States Department of Agriculture’s Food Safety and Inspection Service (USDA/FSIS)
has regulatory authority for meat and poultry. Both USDA/FSIS (64 FR 72167; December 23,
1999) and FDA (65 FR 51758; August 25, 2000) have amended their regulations to harmonize and
improve the efficiency of the procedures used by USDA/FSIS and FDA with respect to reviewing
and approving the use of substances in meat and poultry. In general, USDA/FSIS evaluates food
substances as to their suitability for specified uses in meat or poultry products. When USDA/FSIS
receives a request to evaluate the suitability of a substance for use in meat or poultry products,
USDA/FSIS consults with FDA about the regulatory status of the substance. When FDA receives a
GRAS notice that includes a use in meat or poultry products, FDA consults with USDA/FSIS and
provides to the notifier feedback from USDA/FSIS about the suitability of the substance for use in
meat or poultry products. If USDA/FSIS informs FDA that the use of the substance in meat or
poultry products requires rulemaking under the statutes that FSIS implements, FDA provides that
information to the notifier. FDA and USDA have now signed a Memorandum of Understanding
regarding these procedures (http://www.fsis.usda.gov/Oa/topics/mou_fda.htm?redirecthttp=true).
5. Impact on Small Businesses or Other Small Entities
We estimate ten percent (10%) of respondents are small businesses. However we have attempted to
minimize burden on all respondents, including small businesses, by providing that the notifier
submit a detailed summary of the data and information rather than the underlying data that are the
basis for the conclusion of GRAS status. At the same time, FDA aids small businesses in
complying with its requirements through the agency’s Regional Small Business Representatives and
through the scientific and administrative staffs within the agency. FDA also provides a Small
Business Guide on the agency’s website at http://www.fda.gov/oc/industry/.

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6. Consequences of Collecting the Information Less Frequently
GRAS notifications are submitted only once.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
Under procedures resulting from the proposed rule, GRAS notification records are to be retained for
more than three years. The proposal explains that notifiers would submit a detailed summary of the
information that provides the basis for a conclusion of GRAS status rather than the information
itself, but retain the underlying information and sign a statement that such information is available
for FDA review and copying at reasonable times, or submitted to FDA upon request. There are no
other special circumstances associated with this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in the
Federal Register of September 17, 2015 (80 FR 55857). FDA received the following three
comments in response to the notice:
(Comment 1) One comment “strongly supports FDA’s efforts of improving the Notification
Procedure for Substances GRAS and appreciates and supports the Agency development of Form
FDA 3667 entitled “Generally Recognized as Safe Notice,” to assist with GRAS notice
submissions.”
(Comment 2) One comment questioned whether a new food additive can be GRAS if not
previously used. The comment continued with a suggestion to require data submitted in support of
a GRAS determination to be published and reviewed by independent scientists prior to approval.
(Comment 3) One comment suggested that GRAS notifications require listing the qualified experts
making the safety determination, their credentials, and their affiliations on Form 3667. The
comment suggested that including this information would “minimize the potential for conflicts of
interest in companies’ GRAS determinations” and “provide greater transparency and
accountability” of the substance in question and its safety.
FDA acknowledged and expressed its appreciation for the comments in its 30 day notice responding
that current rulemaking is under way to address these as well as other issues substantive to the
information collection.
9. Explanation of Any Payment or Gift to Respondents
FDA does not provide any payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
FDA proposed that a particular section (i.e., the “GRAS exemption claim”) of a notice be
immediately available for public disclosure on the date the notice is filed. FDA also proposed that
all remaining data and information in a notice will become available for public disclosure, in
accordance with 21 CFR part 20, on the date of receipt of the notice. The general recognition
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standard signifies that neither the proposed use of the substance nor the critical information needed
to establish its safety are confidential. Therefore, FDA presumes that a notice will not contain any
information that is protected from public disclosure. Moreover, because a GRAS substance may be
marketed without prior approval, FDA presumes that, in most cases, submission of a notice will not
reflect the notifier's plans about the timing of commercialization, which is arguably confidential
commercial information (21 CFR 20.61(b)), because a notifier may market a substance at any time
before or after notifying FDA. FDA makes the information in the GRAS exemption claim and the
agency's response to the notice accessible to the public through an electronic inventory of GRAS
notices posted on the agency’s website at
http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=grasListing.
FDA believes that, in most cases, neither the existence of a GRAS notice, nor most or all of its
content, would satisfy the criteria for exemption from disclosure. However, information submitted
to FDA in a GRAS notice may contain trade secret and commercial confidential information. As a
result, all files are maintained in a secured area. Form FDA 3667, its instructions, and related
guidance, provide instructions for assisting FDA with protecting confidential information. A
submitter may choose to provide a redacted copy of the GRAS notice, identifying that information
that the submitter views as trade secret or as confidential commercial or financial information.
Only information that is releasable under the agency’s regulations in 21 CFR part 20 would be
released to the public. This information is also safeguarded by Section 301(j) of the FD&C Act and
would be protected from disclosure under FOIA under sections 552(a) and (b) (5 U.S.C. 552(a) and
(b)).
11. Justification for Sensitive Questions
This information collection does not involve any questions that are of a personally sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
FDA estimates the burden of the information collection as follows:
12 a. Annualized Hour Burden Estimate
Table 1 – Estimated Annual Reporting Burden1
21 CFR
Section

170.36
(CFSAN)
570.36
(CVM)
Total

FDA Form
No.2

No. of
Respondents

No. of
Responses per
Respondent

Total
Annual
Responses

Avg.
Burden per
Response

Total
Hours

FDA 36673

40

1

40

150

6,000

N/A

20

1

20

150

3,000
9,000

1

There are no capital costs or operating and maintenance costs associated with this collection of information.
2
Only CFSAN uses Form FDA 3667.
3
Form FDA 3667 may be submitted electronically via the ESG.

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Table 2 – Estimated Annual Recordkeeping Burden1
21 CFR
Section

No. of
Recordkeepers

No. of Records
per
Recordkeeper

Total
Annual
Records

Avg. Burden per
Recordkeeping

Total
Hours

170.36(c)(v)
(CFSAN)
570.36(c)(v)
(CVM)

40

1

40

15

600

20

1

20

15

300

Total
1

900

There are no capital costs or operating and maintenance costs associated with this collection of information.

For purposes of this extension request, we are retaining our 2012 estimates. The PRA analysis for
the GRAS final rule will take into account any changes to the GRAS notification procedure as set
forth in the final rule and we will revise the collection accordingly.
12 b. Annualized Cost Burden Estimate
FDA estimates the annualized burden hour cost to respondents for this collection of information to
be approximately $903,276. FDA estimates a respondent’s average wage to be that of a Federal
government employee at the GS-13/Step-2 rate for the Washington-Baltimore locality pay area for
the year 2016, which is $45.62 per hour. To account for overhead, this cost is increased by 100
percent, which is $91.24 per hour. Thus, the annual wage cost for completion and submission of
GRAS notifications is approximately $903,276 (9,900 hours x $91.24 per hour). In addition, while
FDA does not charge for the use of the ESG, FDA requires respondents to obtain a public key
infrastructure (PKI) certificate in order to set up the account. This can be obtained in-house or
outsourced by purchasing a public key certificate that is valid for 1 year to 3 years. The certificate
typically costs from $20-$30.
13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers
There are no capital, start-up, operating, or maintenance costs associated with this collection.
14. Annualized Cost to Federal Government
FDA estimates it will direct approximately 4 full time equivalent positions (FTE’s) to the GRAS
notification procedure for human foods. Due to the smaller number of notices anticipated for
animal food, only 3 FTE is expected to be devoted to processing the notices submitted to CVM.
Based on an average cost of $172,000 per fully supported position ($86,000 increased by 100
percent to account for overhead), the cost of processing GRAS notifications would be $1,204,000
per year ($172,000 x 7).
15. Explanation for Program Changes or Adjustments
For purposes of this extension request, we are retaining our 2012 estimates. The PRA analysis for
the GRAS final rule will take into account any changes to the GRAS notification procedure as set
forth in the final rule and we will revise the collection accordingly.

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16. Plans for Tabulation and Publication and Project Time Schedule
FDA proposed to make readily accessible to the public the information in a section of the notice
called the “GRAS exemption claim” and the agency's response to the notice. At this time, FDA is
making this information accessible through an electronic inventory of GRAS notices, available at
http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=grasListing
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There are no reasons why display of the expiration date for OMB approval of the information
collection would be inappropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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