MICROBIAL PRODUCTS OF BIOTECHNOLOGY, THE TOXIC SUBSTANCES CONTROL ACT (PROPOSED RULE)

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
139753	MICROBIAL PRODUCTS OF BIOTECHNOLOGY, THE TOXIC SUBSTANCES CONTROL ACT (PROPOSED RULE) Form	Migrated

ICR Details

OMB Control No: 2070-0012	ICR Reference No: 199408-2070-004
Status: Historical Inactive	Previous ICR Reference No: 199308-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No:
Title: MICROBIAL PRODUCTS OF BIOTECHNOLOGY, THE TOXIC SUBSTANCES CONTROL ACT (PROPOSED RULE)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 10/24/1994
	Date Received in OIRA: 08/25/1994
Terms of Clearance: This ICR for the proposed TSCA Biotechnology rule is not approved. EP has failed to demonstrate that the information is the least burdensome necessary, as required by 5 CFR 1320.6. In the proposed rule, EPA requested comment on a low risk alternative which could reduce the information colletion and recordkeeping requirements for certain researchers. However, this ICR did not calculate the different burden of this approach. In addition, EPA should examine the need to keep records of the selection and use of containment and inactivation procedures given the supervision requirements by a technically qualifi individual. For the final ICR, EPA also should include its best estimate of the burden associated with potential regulatory restrictions (see worksheet 1, 5, and 5A).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/1996	10/31/1996	10/31/1996
Responses	2,289	0	2,289
Time Burden (Hours)	298,550	0	298,550
Cost Burden (Dollars)	0	0	0

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Abstract: THIS REQUEST IS TO COLLECT INFORMATION ON CERTAIN NEW MICROORGANISMS DEVELOPMENT. AFFECTED PUBLIC WILL INCLUDE MANUFACTURERS OF NEW MICROORGANISMS AND PERSONS USING SUCH MICROORGANISMS IN RESEARCH AND DEVELOPMENT. THE AGENCY TAKES NO FURTHER REGULATORY ACTION WITHIN 90 DAYS. SUBMITTERS CAN APPLY FOR CERTAIN EXEMPTIONS WITH SHORTER REVIEW

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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
MICROBIAL PRODUCTS OF BIOTECHNOLOGY, THE TOXIC SUBSTANCES CONTROL ACT (PROPOSED RULE)	0574.07

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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: 08/25/1994

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