General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h & 2567

Forms and Documents

Document Name	Status
Form 356h 601.2(a) - Applications for Biologics Licenses; procedures for filing and 610.60 through 610.65 - Container Label Form and Instruction	Modified
Form 356h 601.6(a) - Suspension of License Form and Instruction	New
Form 356h Amendments/Resubmissions Form and Instruction	New
Form 2567 680.1(b)(3)(iv) - Allergenic Products Form and Instruction	New
Form 2567 680.1(c) - Allergenic Products Form and Instruction	New
Form 2567 610.15(d) - Constituent Materials Form and Instruction	New
Form 2567 601.70(b) and (d)/601.28 - Annual Progress Reports of Postmarketing Studies and Annual reports of postmarketing pediatric studies Form and Instruction	New
Form 2568 601.27(c) - Pediatric Studies Form and Instruction	New
Form 2567 601.27(b) - Pediatric Studies - Deferred Submission Form and Instruction	New
Form 2567 601.26(f) - Additional Studies and Labeling Form and Instruction	New
Form 2567 601.12(f)(4)/601.45 - Changes to an Approved Application Form and Instruction	New
Form 2567 601.12(f)(2) - Changes to an Approved Application Form and Instruction	New
Form 2567 601.12(f)(1) - Changes to an Approved Application Form and Instruction	New
Form 2567 601.12(d)(1)/(d)(3)/(f)(3) - Changes to an Application Form and Instruction	New
Form 356h 601.12(c)(5) - Changes to an Approved Application Form and Instruction	New
Form 2567 601.12(c)(1) and (c)(3) - Changes to an Approved Application Form and Instruction	New
Form 2567 601.12(b)(1)/(b)(3)/(e) - Changes to an Approved Application Form and Instruction	New
Form 2567 601.12(a)(5) - Changes to an Approved Application Form and Instruction	New
Form 2567 601.6(a) - Suspension of License Form and Instruction	Modified
Form 2567 601.5(a) - Revocation of License Form and Instruction	Modified
SUPPORTING STATEMENT 0338 11-7-13.doc Supporting Statement A	2013-11-07

IC Document Collections

IC ID	Document Title	Status
5935	601.2(a) - Applications for Biologics Licenses; procedures for filing and 610.60 through 610.65 - Container Label Form and Instruction	Modified
209329	601.6(a) - Suspension of License Form and Instruction	New
209328	Amendments/Resubmissions Form and Instruction	New
209327	680.1(b)(3)(iv) - Allergenic Products Form and Instruction	New
209326	680.1(c) - Allergenic Products Form and Instruction	New
209325	610.15(d) - Constituent Materials Form and Instruction	New
209324	601.70(b) and (d)/601.28 - Annual Progress Reports of Postmarketing Studies and Annual reports of postmarketing pediatric studies Form and Instruction	New
209323	601.27(c) - Pediatric Studies Form and Instruction	New
209322	601.27(b) - Pediatric Studies - Deferred Submission Form and Instruction	New
209321	601.26(f) - Additional Studies and Labeling Form and Instruction	New
209320	601.12(f)(4)/601.45 - Changes to an Approved Application Form and Instruction	New
209319	601.12(f)(2) - Changes to an Approved Application Form and Instruction	New
209318	601.12(f)(1) - Changes to an Approved Application Form and Instruction	New
209317	601.12(d)(1)/(d)(3)/(f)(3) - Changes to an Application Form and Instruction	New
209316	601.12(c)(5) - Changes to an Approved Application Form and Instruction	New
209315	601.12(c)(1) and (c)(3) - Changes to an Approved Application Form and Instruction	New
209314	601.12(b)(1)/(b)(3)/(e) - Changes to an Approved Application Form and Instruction	New
209313	601.12(a)(5) - Changes to an Approved Application Form and Instruction	New
193381	601.6(a) - Suspension of License Form and Instruction	Modified
193380	601.5(a) - Revocation of License Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0338	ICR Reference No: 201311-0910-007
Status: Historical Active	Previous ICR Reference No: 201006-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: 20859
Title: General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h & 2567
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: 01/03/2014
	Date Received in OIRA: 11/13/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2017	36 Months From Approved	01/31/2014
Responses	28,805	0	20,081
Time Burden (Hours)	324,761	0	341,697
Cost Burden (Dollars)	0	0	0

---

Abstract: Manufacturers are required to submit a license application for review and approval prior to marketing a biological product in interstate commerce. In addition, manufacturers must submit to FDA advertising and promotional labeling. Manufacturers are also required to sbumit changes, including labeling, changes to an approved application, as well as advertising and promotional labeling changes. The information submitted to FDA in a biologics license application (BLA), supplement to an approved application, or other similar submission is used to determin if a product is safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use. Forms FDA 356h and 3567 have been developed for use by the industry to insure that all the required and necessary information concerning licensing and labeling is submitted to FDA. The regulations also describe the types of postmarketing studies that reuqire status reports, the information to be included in the reports, and the type of information that FDA would consider appropriate for public disclosure. FDA uses the information submitted from the reports of postmarketing studies to meet its reporting obligations under section 506B of the Federal Food, Drug, and Comsetic Act and section 130(b) of the Food and Drug Administration Modernization Act and corresponding regulations.

---

Authorizing Statute(s): US Code: 42 USC 262 Name of Law: PHS Act
   US Code: 21 USC 356b 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:
	78 FR 35273	06/12/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 65334	10/31/2013
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 20

IC Title	Form No.	Form Name
601.5(a) - Revocation of License	2567, 356h	Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.6(a) - Suspension of License	2567, 356h	Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.70(b) and (d)/601.28 - Annual Progress Reports of Postmarketing Studies and Annual reports of postmarketing pediatric studies	2567, 356h	Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
610.15(d) - Constituent Materials	2567, 356h	Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
680.1(c) - Allergenic Products	2567, 356h	Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
680.1(b)(3)(iv) - Allergenic Products	2567, 356h	Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
Amendments/Resubmissions	356h	Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.6(a) - Suspension of License	356h	Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.27(b) - Pediatric Studies - Deferred Submission	2567, 356h	Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.27(c) - Pediatric Studies	2568, 356h	Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(c)(5) - Changes to an Approved Application	356h, 2567	Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use ,   Transmittal of Labels and Circulars
601.12(d)(1)/(d)(3)/(f)(3) - Changes to an Application	2567, 356h	Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(f)(1) - Changes to an Approved Application	2567, 356h	Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(f)(2) - Changes to an Approved Application	2567, 356h	Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.2(a) - Applications for Biologics Licenses; procedures for filing and 610.60 through 610.65 - Container Label	356h, 2567	Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use ,   Transmittal of Labels and Circulars
601.12(f)(4)/601.45 - Changes to an Approved Application	2567, 356h	Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.26(f) - Additional Studies and Labeling	2567, 356h	Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(a)(5) - Changes to an Approved Application	2567, 356h	Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(b)(1)/(b)(3)/(e) - Changes to an Approved Application	2567, 356h	Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(c)(1) and (c)(3) - Changes to an Approved Application	2567, 356h	Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use

---

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	28,805	20,081	0	0	8,724	0
Annual Time Burden (Hours)	324,761	341,697	0	0	-16,936	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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: No

Burden Reduction Due to:

Short Statement: The previous burden estimate for 0910-0338 was 341,697. The slight overall decrease in burden to 324,758.60 (-16,938) is attibuted to the normal variation in the various submissions to FDA. A third party disclosure chart was added for a reporting element (i.e., notification of selling agents and distributors) under section 601.6(a) although there was no burden impact since it was previously included under the reporting burden chart. In addition, OMB Control Number 0910-0666 (section 610.15(d)) is being consolidated into this package (1 burden hour).

---

Annual Cost to Federal Government: $17,573,130

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: 11/12/2013

---