Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patients' Perceptions

Forms and Documents

Document	Type	Status	Availability
SUPPORTING STATEMENT PART B PILL APPEARANCE SURVEYS FINAL 5-26-15.doc	Supporting Statement B	Uploaded 2015-05-26	Available
SUPPORTING STATEMENT PART A PILL APPEARANCE SURVEYS FINAL 5-26-15.doc	Supporting Statement A	Uploaded 2015-05-26	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
216612	Patient #2 Survey Completes	Other-Optum Patient Pill Appearance Survey	New
216611	Patients #1 Survey Completes	Other-Nielsen Patient Pill Appearance Survey	New
216610	Patient #1 Surveys Pretests	Other-Nielsen Patient Pill Appearance Survey	New
216609	Patient #1 Surveys Screened	Other-Nielsen Patient Pill Appearance Survey	New
216608	Pharmacist Survey Completes	Other-National Survey of Pharmacists About Pill Appearance	New
216607	Pharmacists Pretests	Other-National Survey of Pharmacists About Pill Appearance	New

ICR Details

OMB Control No: 0910-0801	ICR Reference No: 201505-0910-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patients' Perceptions
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: 09/30/2015
	Date Received in OIRA: 05/28/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2018	36 Months From Approved
Responses	6,348	0	0
Time Burden (Hours)	1,017	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Generic drugs are required to be pharmaceutically equivalent and bioequivalent to their brand-name therapeutic equivalents, but may differ in their physical appearance (e.g., color, shape, size, or markings). This may result in patient confusion and safety and efficacy concerns about the generic drug product, and may cause patients to change or discontinue their medication, which could lead to harmful clinical and public health consequences. Alternatively, differences in appearance may help patients identify their drugs and promote positive public health outcomes. The extent to which differences in appearance between therapeutically equivalent products create or reduce patient confusion, affect patient medication adherence, or are handled by pharmacists is currently unknown. This project will conduct a survey of pharmacists and two surveys of patients regarding their perspectives on and experiences with generic drugs that differ in appearance from previous refills of the same medication. The goals of the surveys are to provide insight into the beliefs about and experiences with changes in the appearance of generic medications, the strategies pharmacists use to notify patients of changes in appearance, and how drug appearance may be related to patient outcomes such as confidence in and adherence to medication regimens.

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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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 61872	10/15/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 27691	05/14/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Pharmacists Pretests
Pharmacist Survey Completes
Patient #1 Surveys Screened
Patient #1 Surveys Pretests
Patient #2 Survey Completes
Patients #1 Survey Completes

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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	6,348	0	0	6,348	0	0
Annual Time Burden (Hours)	1,017	0	0	1,017	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: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a new data collection.

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Annual Cost to Federal Government: $1,372,145

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 05/28/2015

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