FDA Advisory Committee Membership Nominations

Forms and Documents

Document Name	Status
0833 Advisory Committee Nominations SSA 2020.pdf Supporting Statement A	2020-05-11

IC Document Collections

IC ID	Document Title	Status
226376	Update of nomination information	Modified
226352	FDA Advisory Committee Membership Nominations	Modified

ICR Details

OMB Control No: 0910-0833	ICR Reference No: 202005-0910-002
Status: Active	Previous ICR Reference No: 201704-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: FDA Advisory Committee Membership Nominations
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/08/2020
	Date Received in OIRA: 05/11/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2023	36 Months From Approved	06/30/2020
Responses	445	0	647
Time Burden (Hours)	112	0	162
Cost Burden (Dollars)	0	0	0

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Abstract: The information collection supports the submission of nominations to FDA Advisory Committees. Agency regulations governing the operation and responsibilities of Advisory Committees may be found under 21 CFR Part 14. Respondents to the collection are private individuals who nominate individuals to serve on FDA Advisory Committees, or private individuals submitting self-nominations to serve on FDA Advisory Committees.

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Authorizing Statute(s): PL: Pub.L. 92 - 463 8 Name of Law: Federal Advisory Committee Act; Responsibilities of agency heads
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 718	01/07/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 21249	04/16/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
FDA Advisory Committee Membership Nominations
Update of nomination information

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ICR Summary 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	445	647	0	0	-202	0
Annual Time Burden (Hours)	112	162	0	0	-50	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: We have made adjustments to the information collection to reflect fewer membership nominations and submissions of updated information, for a reduction of 202 responses and 50 hours annually.

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Annual Cost to Federal Government: $10,000

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.     Yes

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

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Common Form ICR:  No

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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: 05/11/2020

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