Postmarketing Safety Reporting for Combination Products

Forms and Documents

Document Name	Status
ss postmarketing safety for combo products NPRM 9-9-09.doc Supporting Statement A	2009-09-30

IC Document Collections

IC ID	Document Title	Status
191027	Developing SOPs for new combination products	New
191026	Blood Fatality report (21 CFR 4.103(b)(5)	New
191025	Field Alert report (21 CFR 4.103(b)(4))	New
191024	Postmarketing 15-day Alert report (21 CFR 4.103(b)(3))	New
191023	Malfunction report (21 CFR 4.103(b)(2))	New
191022	5 day report (21 CFR 4.103(b)(1))	New

ICR Details

OMB Control No: 0910-0834	ICR Reference No: 200910-0910-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Postmarketing Safety Reporting for Combination Products
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: Comment filed on proposed rule	Conclusion Date: 01/26/2010
	Date Received in OIRA: 10/16/2009
Terms of Clearance: OMB is filing comment on this ICR which is associated with a proposed rule. Approval is not granted at this time. FDA should resubmit this ICR in conjunction with the final rule. At that time, FDA will consider public comments and estimate the number of respondents who will avail themselves of the streamlined reporting requirements proposed in the rule for combination products. Accordingly, FDA will revise its estimates of the consequent reduction in reporting and recordkeeping burden currently allocated to separate information collection requests (i.e. OMB control numbers 0910-0001, 0910-0230, 0910-0291, 0910-0308, 0910-0116, and 0910-0437).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: To ensure appropriate ongoing postmarketing surveillance of risks, to ensure the consistency of the agency's postmarketing regulation of combination products, to streamline requirements for reporters by avoiding duplicative reporting requirements, FDA proposes to create 21 CFR part 4, subpart B to clarify postmarketing safety reporting requirements for combination products.

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Authorizing Statute(s): US Code: 21 USC 353 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:
0910-AF82	Proposed rulemaking	74 FR 50744	10/01/2009

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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: 6

IC Title	Form No.	Form Name
5 day report (21 CFR 4.103(b)(1))
Malfunction report (21 CFR 4.103(b)(2))
Postmarketing 15-day Alert report (21 CFR 4.103(b)(3))
Field Alert report (21 CFR 4.103(b)(4))
Blood Fatality report (21 CFR 4.103(b)(5)
Developing SOPs for new combination products

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

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: FDA proposes to create 21 CFR part 4, subpart B to clarify postmarketing safety reporting requirements for combination products.

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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)? No

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: 10/16/2009

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