Orphan Drug Regulations

Forms and Documents

Document Name	Status
Orphan Drugs ss 6-11-13.doc Supporting Statement A	2013-06-11

IC Document Collections

IC ID	Document Title	Status
199798	Granting orphan-drug designation	Modified
199797	Content and format of a request for orphan-drug designation	Modified

ICR Details

OMB Control No: 0910-0702	ICR Reference No: 201306-0910-009
Status: Historical Active	Previous ICR Reference No: 201110-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: 19743
Title: Orphan Drug Regulations
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: 09/16/2013
	Date Received in OIRA: 06/18/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2016	36 Months From Approved
Responses	30	0	0
Time Burden (Hours)	64	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Amendments to these regulations are intended to clarify regulatory provisions and make minor improvements to address isues that have arisen since the issuance of the regulations in 1992. They are intended to assist sponsors who are seeking and who have obtained orphan--drug designations, as well as FDA in its administration of the orphan drug program.

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Authorizing Statute(s): US Code: 21 USC 525-528 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG72	Final or interim final rulemaking	78 FR 35117	06/12/2013

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Content and format of a request for orphan-drug designation
Granting orphan-drug designation

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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	30	0	0	30	0	0
Annual Time Burden (Hours)	64	0	0	64	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: Changing Regulations

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

Burden Reduction Due to:

Short Statement: This is a new information collection resulting from amending current regulations intended to assist sponsors who are seeking and who have obtain orphan-drug designations.

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Annual Cost to Federal Government: $650

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: 06/18/2013

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