Medical Devices; Exception from General Requirements for Informed Consent

Forms and Documents

Document	Type	Status	Availability
SS 0910-0586.doc	Supporting Statement A	Uploaded 0000-00-00	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
6309	Medical Devices; Exception from General Requirements for Informed Consent		Modified

ICR Details

OMB Control No: 0910-0586	ICR Reference No: 200702-0910-010
Status: Historical Active	Previous ICR Reference No: 200603-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Medical Devices; Exception from General Requirements for Informed Consent
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: 05/15/2007
	Date Received in OIRA: 02/21/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2010	36 Months From Approved	05/31/2007
Responses	900	0	450
Time Burden (Hours)	1,350	0	900
Cost Burden (Dollars)	0	0	0

---

Abstract: The interim final rule would amend FDAs informed consent regulation to provide an exception to the general requirement to obtain informed consent from the subject of an investigation involving and unapproved or not cleared in vitro diagnostic device intended to identify a chemical, biological, radiological, or nuclear agent.

---

Authorizing Statute(s): Statute at Large: 21 Stat. 360 Name of Statute: null
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AC25	Final or interim final rulemaking	71 FR 32827	06/07/2006

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 32827	06/07/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 7662	02/16/2007
Did the Agency receive public comments on this ICR? Yes

---

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

IC Title	Form No.	Form Name
Medical Devices; Exception from General Requirements for Informed Consent

---

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	900	450	0	450	0	0
Annual Time Burden (Hours)	1,350	900	0	450	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: Changing Regulations

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

Burden Reduction Due to:

Short Statement: The number of laboratories (respondents) was changed (adjusted) to 150 laboratories that perform this type testing. Thus this adjustment resulted in an increase in the total burden estimate from 600 hours to 1350.

---

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

---

Common Form ICR:  No

---

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: 02/21/2007

---