USE OF ASEPTIC PROCESSING AND TERMINAL STERILIZATION IN THE PREPARATION OF STERILE PHARMACEUTICALS FOR HUMAN AND VETERINARY USE - NPRM

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Forms and supporting documents for this ICR

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Information collection document groups

IC ID	Collection	Type	Status	Form
109977	USE OF ASEPTIC PROCESSING AND TERMINAL STERILIZATION IN THE PREPARATION OF STERILE PHARMACEUTICALS FOR HUMAN AND VETERINARY USE - NPRM		Migrated

ICR Details

OMB Control No:	ICR Reference No: 199110-0910-002
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: USE OF ASEPTIC PROCESSING AND TERMINAL STERILIZATION IN THE PREPARATION OF STERILE PHARMACEUTICALS FOR HUMAN AND VETERINARY USE - NPRM
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: Disapproved	Conclusion Date: 12/18/1991
	Date Received in OIRA: 10/25/1991
Terms of Clearance: SEE ATTACHED COMMENTS.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: WOULD REQUIRE MANUFACTURERS TO USE TERMINAL STERILIZATION WHEN PREPARING STERILE DRUG PRODUCTS. WOULD REQUIRE JUSTIFICATIONS WHEN ASEPTIC PROCESSING IS USED.

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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

table that charts list of burden

IC Title	Form No.	Form Name
USE OF ASEPTIC PROCESSING AND TERMINAL STERILIZATION IN THE PREPARATION OF STERILE PHARMACEUTICALS FOR HUMAN AND VETERINARY USE - NPRM

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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:

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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: 10/25/1991

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