Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products - Proposed Rule

Forms and Documents

Document	Type	Status	Availability
SUPPORTING STATEMENT EDL PR FINAL 1 5-28-15.doc	Supporting Statement A	Uploaded 2015-05-28	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
216756	Distribution of Prescribing Information by Fax, Email, or Mail When Requested		New
216755	Production of New Label Statement on Immediate Container Label or Outside Package (Web site and Toll-Free Number)		New
216754	Submission of Circular of Information by Blood Establishments		New
216753	Review for Accuracy and Completeness of Posted Prescribing Information		New
216752	Requests to Receive Prescribing Information by Fax, Email, or Mail When Requested		New
216751	Requests for Exemptions		New
216750	Review of Accuracy of Posted Labeling and Circular of Information		New
216749	Submission of Updated Labeling and Circular of Information		New

ICR Details

OMB Control No: 0910-0794	ICR Reference No: 201412-0910-014
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products - 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: 05/29/2015
	Date Received in OIRA: 12/30/2014
Terms of Clearance: Prior to publication of the final rule, the agency should provide a summary of all comments related to the information collection requirements contained in the rule and any changes made in response to these comments.

	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

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Abstract: The rulemaking would amend FDA's prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for healthcare professionals.

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Authorizing Statute(s): US Code: 21 USC 360, 360b, 360gg-360ss, 371 Name of Law: FD&C Act
   US Code: 21 USC 374, 379e Name of Law: FD&C Act
   US Code: 21 USC 321, 331, 351-353, 355, 358 Name of Law: FD&C Act
   US Code: 42 USC 216, 241, 262, & 264 Name of Law: PHS Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG18	Proposed rulemaking	79 FR 75506	12/18/2014

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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: 8

IC Title	Form No.	Form Name
Review for Accuracy and Completeness of Posted Prescribing Information
Submission of Circular of Information by Blood Establishments
Distribution of Prescribing Information by Fax, Email, or Mail When Requested
Requests to Receive Prescribing Information by Fax, Email, or Mail When Requested
Requests for Exemptions
Submission of Updated Labeling and Circular of Information
Review of Accuracy of Posted Labeling and Circular of Information
Production of New Label Statement on Immediate Container Label or Outside Package (Web site and Toll-Free Number)

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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: This is a new collection.

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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]? 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

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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: 12/30/2014

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