LICENSE APPLICATIONS FOR THE MANUFACTURE OF VIRAL, BACTERIAL ALLERGENICS, AND PLASMA DERIVATIVES PRODUCTS AND GENERAL

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
109644	LICENSE APPLICATIONS FOR THE MANUFACTURE OF VIRAL, BACTERIAL ALLERGENICS, AND PLASMA DERIVATIVES PRODUCTS AND GENERAL Form	Migrated

ICR Details

OMB Control No: 0910-0124	ICR Reference No: 198103-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: LICENSE APPLICATIONS FOR THE MANUFACTURE OF VIRAL, BACTERIAL ALLERGENICS, AND PLASMA DERIVATIVES PRODUCTS AND GENERAL
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: 05/20/1981
	Date Received in OIRA: 03/11/1981
Terms of Clearance: This information request is approved for 90 days. During that time FDA is to re-estimate the burden for the subject applications. OMB believes that the burden estimate of 2 hrs/response may be grossly underestimated. OMB's definition of burden includes all the time it takes to respond to an information collection request, including time required to read instructions, time required to assemble source materials, time required to process materials and put them into the necessary format and the time required to report the information. Therefore, time required for laboratory testing of new drugs or biologics (see 21CFR 601.2) should be included in burden estimates. Additionally, within the 90 day period, FDA should request approval for all information collection required by 21CFR 600 - Subchapter F which have not already been submitted for clearance.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/1981	08/31/1981
Responses	144	0	0
Time Burden (Hours)	288	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: SECTION 351 OF THE PUBLIC HEALTH SERVICE ACT AND 21 CFR 601.2 REQUIRES ALL MANUFACTURERS OF BIOLOGICAL PRODUCTS TO SUBMIT APPLICATIONS FOR REVIEW AND APPROVAL TO THE BUREAU OF BIOLOGICS PRIOR TO MARKETING A PRODUCT. A SEPARATE LICENSE IS ISSUED TO THE MANUFACTURER FOR EACH APPROVED PRODUCT APPLICATION. THE DATA IS USED TO DETERMINE IF THE MANUFACTURER IS IN COMPLIANCE WITH LICENSE PROVISIONS OF THE REGULA TIONS.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
LICENSE APPLICATIONS FOR THE MANUFACTURE OF VIRAL, BACTERIAL ALLERGENICS, AND PLASMA DERIVATIVES PRODUCTS AND GENERAL	FDA 3210,, 3211, 3212,, 3213, 3214

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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	144	0	0	144	0	0
Annual Time Burden (Hours)	288	0	0	288	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:

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

Burden Reduction Due to:

Short Statement:

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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

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Common Form ICR:  No

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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: 03/11/1981

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