Forms and Documents

Document Name	Status
0045 Drug Reg and Listing SSA 2021 REV Amended.docx Supporting Statement A	2021-12-07

IC Document Collections

IC ID	Document Title	Status
5696	Initial establishment registration Other-Agency Guidance	Unchanged
250057	CARES 3112(e); reporting drug manufacture amounts and exemption from reporting - drug shortage determinations Other-Public Law: CARES Act	Unchanged
187821	RECORDKEEPING: One-Time Preparation of SOP	Unchanged
187820	Waiver requests	Unchanged
183175	June and December review and updates (or certifications) of listing (including NDC) information Other-Agency Guidance	Unchanged
183174	Requests for exemptions from public disclosures under 207.81 Other-Agency Guidance	Unchanged
183173	Initial listing (including NDC) information Other-Agency Guidance	Unchanged
183172	Annual Updates of Registration Information (including expedited updates) Other-Agency Guidance	Unchanged

ICR Details

OMB Control No:	ICR Reference No:
Status:	Previous ICR Reference No:
Agency/Subagency:	Agency Tracking No:
Title:
Type of Information Collection:	Common Form ICR:
Type of Review Request:	Date Received in OIRA:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract:

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR?

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Number of Information Collection (IC) in this ICR: 0

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ICR Summary of Burden

	Total	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	0	0	0	0	0	0
Annual Time Burden (Hours)	0	0	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion:

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion:

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government:

Does this IC contain surveys, censuses, or employ statistical methods?

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.    

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.    

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?

Is this ICR related to the Pandemic Response?

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Common Form ICR: 

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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:

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