Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings with the Office of Orphan Products Development

Forms and Documents

Document Name	Status
0787_Supporting Statement.doc Supporting Statement A	2018-03-07

IC Document Collections

IC ID	Document Title	Status
214017	Meeting requests (formal and informal); meeting packages; meeting minutes Other-Guidance Document	Modified

ICR Details

OMB Control No: 0910-0787	ICR Reference No: 201802-0910-002
Status: Active	Previous ICR Reference No: 201411-0910-014
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: Guidance for Industry, Researchers, Patient Groups, and FDA Staff on Meetings with the Office of Orphan Products Development
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/15/2018
	Date Received in OIRA: 03/08/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2021	36 Months From Approved	05/31/2018
Responses	2,508	0	2,279
Time Burden (Hours)	9,016	0	8,184
Cost Burden (Dollars)	0	0	0

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Abstract: The collection of information described in the guidance is intended to provide background information in support of consistent procedures to promote well-managed meetings between OOPD and stakeholders. In some cases, these meetings may represent a critical point in the orphan product development process and may even have an impact on the eventual availability of products for patients with rare diseases and conditions. It is therefore important that these meetings be scheduled within a reasonable time, conducted effectively, and documented where appropriate. The draft guidance describes three collections of information: (1) The submission of a meeting request (for informal and formal meeting), (2) the submission of a meeting package (for formal meetings), and (3) the submission of draft meeting minutes (for formal and certain informal meetings.)

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Authorizing Statute(s): US Code: 24 USC 241 Name of Law: null
  

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:
	82 FR 54357	11/17/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 8880	03/01/2018
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
Meeting requests (formal and informal); meeting packages; meeting minutes

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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	2,508	2,279	0	0	229	0
Annual Time Burden (Hours)	9,016	8,184	0	0	832	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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: The change in burden hour is a result of an increase in meeting requests over the past 3 years. The estimated annual hourly burden, formerly estimated as 8,184 hours, has increased by 832 hours to a total estimated annual hourly burden of 9,016 hours.

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Annual Cost to Federal Government: $180,450

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 03/08/2018

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