Administrative Practices and Procedures; Formal Hearings

Forms and Documents

Document Name	Status
0191 Admin Regs SSA 2020 REV.pdf Supporting Statement A	2020-05-31

IC Document Collections

IC ID	Document Title	Status
5800	Notice of participation	Modified
242055	Meetings and correspondence	New
242054	Guidance submissions for proposed development and/or withdraw	New
242053	Request for waiver, suspection, or modification of requirements	New
216312	Filing Objections and Requests for a Hearing on a Regulation or Order	Modified
216311	Advisory Opinions	Modified
216309	Administrative Stay of Action	Modified
216308	Administrative Reconsideration of Action	Modified
216306	Citizen petitions and petitions related to ANDA, certain NDAs, and certain BLAs Other-Agency Guidance Document	Modified

ICR Details

OMB Control No: 0910-0191	ICR Reference No: 202005-0910-003
Status: Active	Previous ICR Reference No: 201805-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: Administrative Practices and Procedures; Formal Hearings
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/07/2020
	Date Received in OIRA: 06/01/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2023	36 Months From Approved	08/31/2021
Responses	1,096	0	227
Time Burden (Hours)	9,720	0	5,194
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports Food and Drug Administration (FDA, the agency, us or we) regulations found in 21 CFR Part 10, 21 CFR Parts 12 through 16, and 21 CFR Part 19 (21 CFR §§ 10, 12-16, and 19). These regulations are established in accordance with the Administrative Procedures Act and implement administrative practice and procedures to give instructions to those conducting business with FDA.

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Authorizing Statute(s): US Code: 21 USC 371 Name of Law: FFDCA
  

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 1169	01/09/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 29459	05/15/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Administrative Stay of Action
Notice of participation
Administrative Reconsideration of Action
Advisory Opinions
Filing Objections and Requests for a Hearing on a Regulation or Order
Citizen petitions and petitions related to ANDA, certain NDAs, and certain BLAs
Request for waiver, suspection, or modification of requirements
Guidance submissions for proposed development and/or withdraw
Meetings and correspondence

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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	1,096	227	0	0	869	0
Annual Time Burden (Hours)	9,720	5,194	0	0	4,526	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: The information collection reflects an overall increase to the collection by 4,526 hours and 869 responses annually resulting from consolidating related elements.

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Annual Cost to Federal Government: $305,510

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: 06/01/2020

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