Reporting and Recordkeeping Requirements for the Proposed Rule on Management Standards for Hazardous Waste Pharmaceuticals (Proposed Rule)

Forms and Documents

Document	Type	Status	Availability
2486ss01.docx	Supporting Statement A	Uploaded 2015-08-24	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
217986	Requirements for Proposed Rule on Hazardous Waste Pharmaceuticals		New

ICR Details

OMB Control No: 2050-0212	ICR Reference No: 201508-2050-002
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: EPA/OLEM	Agency Tracking No: 2486.01
Title: Reporting and Recordkeeping Requirements for the Proposed Rule on Management Standards for Hazardous Waste Pharmaceuticals (Proposed Rule)
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: Comment filed on proposed rule	Conclusion Date: 11/02/2015
	Date Received in OIRA: 09/28/2015
Terms of Clearance: OMB files this comment in accordance with 5 CFR 1320.11(c). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. OMB is withholding approval at this time. Prior to publication of the final rule, the agency should provide a summary of any comments related to the information collection and their response, including any changes made to the ICR as a result of comments. In addition, the agency must enter the correct burden estimates. This action has no effect on any current approvals.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: The requirements covered in this ICR are necessary for EPA to identify the universe of healthcare facilities and pharmaceutical reverse distributors managing hazardous waste pharmaceuticals under 40 CFR part 266 subpart P. The notification requirements are needed to assist the Agency and regulated facilities in tracking hazardous waste pharmaceuticals. EPA is also proposing to require healthcare facilities and pharmaceutical reverse distributors to keep records of any test results, waste analyses or other determinations made on hazardous waste pharmaceuticals. EPA will use the collected information to ensure that hazardous waste pharmaceuticals are being managed in a protective manner. The tracking requirements ensure that these hazardous wastes arrive at their intended destinations rather than facilities not equipped to manage these hazardous wastes. These tracking requirements will also help facilities identify shipments that do not arrive at their destination as planned, allowing generators to take corrective action that will ensure that future shipments are transported to the appropriate location. In addition, during a facility inspection, information kept in facility records will help EPA and state environmental regulatory agencies determine whether or not regulatory requirements are being followed. Information marked on pharmaceutical waste containers will assist handlers and transporters in ensuring proper management during storage and shipment.

---

Authorizing Statute(s): US Code: 42 USC 6901 Name of Law: Resource Conservation and Recovery Act (RCRA)
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
2050-AG39	Proposed rulemaking	80 FR 58013	09/25/2015

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
Requirements for Proposed Rule on Hazardous Waste Pharmaceuticals

---

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: No

Burden Reduction Due to:

Short Statement: Program change due to new proposed rule.

---

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]? 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: 09/28/2015

---