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 FDA 356h General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	Modified
Form FDA 356h General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
Form FDA 2567 General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
Form FDA 2567 General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
Form FDA 2567 General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
Form FDA 356h General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
Form FDA 356h General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
Form FDA 356h General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
Form FDA 356h General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
Form FDA 356h General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
Form FDA 356h General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
Form FDA 356h General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
0338 CoverMemotoOMB 1-2007.doc Supplementary Document	0000-00-00
0338 US CODE TITLE 42 262 2007.doc Supplementary Document	0000-00-00
0338 21cfr680 1 2007.pdf Supplementary Document	0000-00-00
0338 21cfr610 67 2007.pdf Supplementary Document	0000-00-00
0338 21cfr610 62 2007.pdf Supplementary Document	0000-00-00
0338 21cfr610 61 2007.pdf Supplementary Document	0000-00-00
0338 21cfr610 60 2007.pdf Supplementary Document	0000-00-00
0338 21cfr610 53 2007.pdf Supplementary Document	0000-00-00
0338 21cfr610 11 2007.pdf Supplementary Document	0000-00-00
0338 21cfr606 110 2007.pdf Supplementary Document	0000-00-00
0338 21cfr601 94 2007.pdf Supplementary Document	0000-00-00
0338 21cfr601 91 2007.pdf Supplementary Document	0000-00-00
0338 21cfr601 70 2007.pdf Supplementary Document	0000-00-00
0338 21cfr601 45 2007.pdf Supplementary Document	0000-00-00
0338 21cfr601 35 2007.pdf Supplementary Document	0000-00-00
0338 21cfr601 34 2007.pdf Supplementary Document	0000-00-00
0338 21cfr601 33 2007.pdf Supplementary Document	0000-00-00
0338 21cfr601 28 2007.pdf Supplementary Document	0000-00-00
0338 21cfr601 27 2007.pdf Supplementary Document	0000-00-00
0338 21cfr601 26 2007.pdf Supplementary Document	0000-00-00
0338 21cfr601 25 2007.pdf Supplementary Document	0000-00-00
0338 21cfr601 14 2007.pdf Supplementary Document	0000-00-00
0338 21cfr601 12 2007.pdf Supplementary Document	0000-00-00
0338 21cfr601 5 and 601 6 2007.pdf Supplementary Document	0000-00-00
0338 21cfr601 2 2007.pdf Supplementary Document	0000-00-00
0338 21cfr600 15 2007.pdf Supplementary Document	0000-00-00
0338 21 USC 356b 2007.doc Supplementary Document	0000-00-00
0338 ss 2007.doc Supporting Statement A	0000-00-00

IC Document Collections

IC ID	Document Title	Status
5935	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	Modified
179403	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	New
179402	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
179401	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	New
179400	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	New
179399	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	New
179398	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
179397	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	New
179396	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	New
179395	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	New
179394	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
179393	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
179392	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
179391	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
179390	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
179389	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
179388	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
179387	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
179386	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Form and Instruction	New
179385	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	New
179384	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	New
179383	General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	New

ICR Details

OMB Control No: 0910-0338	ICR Reference No: 200703-0910-017
Status: Historical Active	Previous ICR Reference No: 200507-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/08/2007
	Date Received in OIRA: 03/30/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2010	36 Months From Approved	09/30/2008
Responses	14,355	0	14,613
Time Burden (Hours)	335,808	0	335,088
Cost Burden (Dollars)	0	0	0

---

Abstract: The PHS Act and FDA regulations require manufacturers to submit a license application for review and approval prior to marketing a biological product in interstate commerce. Manufacturers must also submit to FDA supplements to an approved application, and advertising, and promotional labeling. There are also requirements regarding suspension and revocation of a license. The regulations also require each applicant of a licensed biological product to submit an annual progress report to FDA on the status of postmarketing studies for each approved biologics license application required by FDA or committed to by the applicant.

---

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:
	71 FR 64536	11/02/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 5057	02/02/2007
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 22

IC Title	Form No.	Form Name
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	FDA 356h	Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	FDA 356h	Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	FDA 356h	Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	FDA 2567, FDA 356h	Transmittals of Labels and Circulars ,   Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	FDA 2567	Transmittals of Labels and Circulars
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	FDA 356h	Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	FDA 356h	Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	FDA 356h	Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	FDA 356h	Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	FDA 356h	Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	FDA 356h	Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567	FDA 2567	Transmittals of Labels and Circulars

---

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	14,355	14,613	0	-258	0	0
Annual Time Burden (Hours)	335,808	335,088	0	720	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The slight increase is attributed to the consolidation of 0910-0433 into this information collection.

---

Annual Cost to Federal Government: $110

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: 03/30/2007

---