PROPOSED RULE - ADVERSE DRUG EXPERIENCE REPORTING REQUIREMENTS FOR MARKETED PRESCRIPTION DRUGS WITHOUT APPROVED NEW DRUG OR ABBREVIATED NEW DRUG APPLICATIONS

Forms and Documents

Document Name	Status

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

IC Document Collections

IC ID	Document Title	Status
165481	PROPOSED RULE - ADVERSE DRUG EXPERIENCE REPORTING REQUIREMENTS FOR MARKETED PRESCRIPTION DRUGS WITHOUT APPROVED NEW DRUG OR ABBREVIATED NEW DRUG APPLICATIONS	Migrated

ICR Details

OMB Control No: 0910-0210	ICR Reference No: 198606-0910-002
Status: Historical Active	Previous ICR Reference No: 198503-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: PROPOSED RULE - ADVERSE DRUG EXPERIENCE REPORTING REQUIREMENTS FOR MARKETED PRESCRIPTION DRUGS WITHOUT APPROVED NEW DRUG OR ABBREVIATED NEW DRUG APPLICATIONS
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 06/24/1986
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/24/1986
	Date Received in OIRA: 06/24/1986
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/1988	05/31/1988	05/31/1988
Responses	1,200	0	1
Time Burden (Hours)	1,600	0	1
Cost Burden (Dollars)	0	0	0

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Abstract: THE PROPOSED RULE WOULD REQUIRE MANUFACTURERS, PACKERS & DISTRIBUTORS OF UNAPPROVED MARKETED PRESCRIPTION DRUG PRODUCTS TO REPORT TO FDA WHENEVER THEY RECEIVE INFORMATION ABOUT ANY SERIOUS AND UNEXPECTED ADVERSE EVENT ASSOCIATED WITH THE USE OF ONE OF THEIR MARKETED DRUG PRODUCTS. CURRENT REGS. ONLY REQUIRE THE REPORTING OF ADVERSE DRUG EXPERIENCES FOR APPROVAL DRUG PRODUCTS. THUS, THESE REQUIREMENTS, WHEN ISSUED AS A FINAL RULE, WILL PROVIDE FDA WITH THE INFO. IT NEEDS.

Emergency Justfication:

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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? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
PROPOSED RULE - ADVERSE DRUG EXPERIENCE REPORTING REQUIREMENTS FOR MARKETED PRESCRIPTION DRUGS WITHOUT APPROVED NEW DRUG OR ABBREVIATED NEW DRUG APPLICATIONS

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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	1,200	1	0	1,199	0	0
Annual Time Burden (Hours)	1,600	1	0	1,599	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:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $0

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

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

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

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

Is this ICR related to the Pandemic Response? Uncollected

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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: 06/24/1986

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