Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format

Forms and Documents

Document	Type	Status	Availability
pra0530 final SS 2010.doc	Supporting Statement A	Uploaded 2010-05-10	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
6248	Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format		Modified
178673	Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format	Other-Other	Removed
178672	Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format	Other-Other	Removed
178671	Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format	Other-Other	Removed
178670	Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format	Other-Other	Removed
178669	Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format	Other-Other	Removed
178668	Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format	Other-Other	Removed
178667	Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format	Other-Other	Removed
178666	Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format	Other-Other	Removed

ICR Details

OMB Control No: 0910-0530	ICR Reference No: 201005-0910-007
Status: Historical Inactive	Previous ICR Reference No: 200702-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 06/14/2010
	Date Received in OIRA: 05/18/2010
Terms of Clearance: In accordance with 5 CFR 1320 OMB notes that this collection has been improperly submitted. The collection has been submitted as an extension but appears to contain a discretionary change in burden. Please correct this error and resubmit this collection to OMB.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2010	36 Months From Approved	06/30/2010
Responses	14,714	0	14,714
Time Burden (Hours)	3,680	0	3,680
Cost Burden (Dollars)	0	0	0

---

Abstract: The information collection requires the electronic submission of the content of labeling (i.e., the content of the package insert or professional labeling, including all text, tables and figures) in NDA's, certain BLA's, ANDA's, supplements, and annual reports electronically in a form that FDA can process, review, and archive. The form that FDA can accept for processing, reviewing, and archiving under the final rule is portable dcoument format (PDF).

---

Authorizing Statute(s): US Code: 21 USC 321 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 57491	11/09/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 23779	05/04/2010
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
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format

---

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

Burden Increase Due to:

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The changes in burden are the result of a re-calculation based on the guidance for industry entitled "Providing Regulatory Submissions in Electronic Format - Drug Establishment Registration and Listing."

---

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]? 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

---

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: 05/18/2010

---