Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements - Final Rule

Forms and Documents

Document	Type	Status	Availability
Form 3500A 600.81(b)(2)	Form	Unchanged	Available
Form 3500A 600.80(h)(2)	Form	Unchanged	Available
Form 3500A 329.100(c)(2)	Form	Unchanged	Available
Form 3500A 314.80(g)(2)	Form	Unchanged	Available
Form 3500A 310.305(e)(2)	Form	Unchanged	Available
SUPPORTING STATEMENT FINAL RULE ESR revised #15 11-7-2014.doc	Supporting Statement A	Uploaded 2014-11-07	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
211827	600.81(b)(2)	Form	Unchanged
211825	600.80(h)(2)	Form	Unchanged
211824	329.100(c)(2)	Form	Unchanged
211823	314.80(g)(2)	Form	Unchanged
211822	310.305(e)(2)	Form	Unchanged

ICR Details

OMB Control No: 0910-0770	ICR Reference No: 201411-0910-004
Status: Historical Active	Previous ICR Reference No: 201406-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements - Final Rule
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: Approved without change	Conclusion Date: 02/03/2015
	Date Received in OIRA: 11/10/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2018	36 Months From Approved
Responses	13	0	0
Time Burden (Hours)	13	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: FDA is requiring that all postmarketing safety reports for human drugs and biological products be submitted in electronic format. Requiring submission of these reports in electronic format will expedite access to safety information and facilitate international harmonization and exchange of this information. This, in turn, will lead to more efficient reviews of safety data and enhance our ability to rapidly disseminate safety information to health care providers, consumers, applicants, sponsors, and other regulatory authorities in support of FDA's public health mission. In addition, the Agency will recognize a significant cost savings by converting the safety reporting system from a paper submission process to an all electronic system that would increase the accuracy of information and reduce the need for manual data entry. The final rule will expedite the identification of emerging safety problems, improve the speed and efficiency of industry and agency operations, and further the international harmonization of safety reporting.

---

Authorizing Statute(s): US Code: 21 USC 356,356a,b,c,360,371,374,375 Name of Law: FD&C Act
   US Code: 21 USC 379k-l,379aa, and 381 Name of Law: FD&C Act
   US Code: 42 USC 241, 261, 264 Name of Law: PHS Act
   US Code: 21 USC 321,331,351,352,353,355,355a Name of Law: FD&C Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF96	Final or interim final rulemaking	79 FR 33072	06/10/2014

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
310.305(e)(2)	3500A	MedWatch
314.80(g)(2)	3500A	MedWatch
329.100(c)(2)	3500A	MedWatch
600.80(h)(2)	3500A	MedWatch
600.81(b)(2)	3500A	MedWatch

---

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	13	0	0	13	0	0
Annual Time Burden (Hours)	13	0	0	13	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: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: The information collection request revises the currently approved collection under OMB Control No. 0910-0770. The "Stage of Rulemaking" was mistakenly entered in ROCIS as a Proposed Rule, and should have been entered as a Final Rule. There are no other changes to this information collection request

---

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]? 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? 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: 11/10/2014

---