Substances Generally Recognized as Safe: Best Practices for Convening a GRAS Panel

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
254332	Third Party Disclosure - GRAS Panel Members Provide Information to the Proponents		New
254331	Recordkeeping - Application of Written GRAS Panel Policy to GRAS Panel Members		New
254330	Recordkeeping - Establishing a Written GRAS Panel Policy (One-time)		New

ICR Details

OMB Control No: 0910-0911	ICR Reference No: 202206-0910-010
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Substances Generally Recognized as Safe: Best Practices for Convening a GRAS Panel
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/05/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/01/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2025	36 Months From Approved
Responses	1,824	0	0
Time Burden (Hours)	39,120	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: FDA seeks OMB approval for the final guidance document entitled, “Best Practices for Convening a Generally Recognized as Safe Panel,” which, once finalized, would assist persons who choose to convene a panel of experts in support of a conclusion that the use of a substance in food is generally recognized as safe (GRAS). To support a GRAS conclusion, a proponent may convene a panel of qualified experts to provide evidence that generally available safety data and information about the intended use of the substance in food are generally accepted among experts, which is one of the criteria for eligibility for GRAS status. The information collection recommendations (establishment of a written GRAS panel policy, solicitation of information from prospective GRAS panel members about potential conflicts of interest and other sources of bias, and documentation of the application of the GRAS panel policy to each GRAS panel member) would help the respondent to identify GRAS panel members who have appropriate and balanced expertise and reduce the risk that bias (or the appearance of bias) will affect the credibility of the GRAS panel’s output.

---

Authorizing Statute(s): US Code: 21 USC 321(s) Name of Law: Federal Food, Drug and Cosmetic Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking
	Other Documents for OIRA Review

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 53433	11/16/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 65082	10/27/2022
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

IC Title	Form No.	Form Name
Recordkeeping - Application of Written GRAS Panel Policy to GRAS Panel Members
Recordkeeping - Establishing a Written GRAS Panel Policy (One-time)
Third Party Disclosure - GRAS Panel Members Provide Information to the Proponents

---

ICR Summary of Burden

table that charts list of burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	1,824	0	0	1,824	0	0
Annual Time Burden (Hours)	39,120	0	0	39,120	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This request for approval of a new information collection results in a program change of 39,120 burden hours and 1,824 responses to support the final guidance document "Best Practices for Convening a GRAS Panel."

---

Annual Cost to Federal Government: $8,121

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

---

Common Form ICR:  No

---

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 11/01/2022

---