ORPHAN DRUG REGULATIONS - NPRM

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
109976	ORPHAN DRUG REGULATIONS - NPRM		Migrated

ICR Details

OMB Control No:	ICR Reference No: 199108-0910-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: ORPHAN DRUG REGULATIONS - NPRM
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: Disapproved	Conclusion Date: 11/21/1991
	Date Received in OIRA: 08/30/1991
Terms of Clearance: This information collection request is disapproved because it was improperly submitted under the requirements of section 3504(h)(1) of the Paperwork Reduction Act. Since this request is for paperwork contained in a proposed rule the disapproval will have no effect beyon indicating there may be some paperwork concerns that should be addressed in the final rule. OMB asks that FDA examine the feasibilit of sponsors providing much of the information on "current regulatory a marketing status and history of the drug product (21 CFR 316.10 (b)(7)

table that charts list comparision

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

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Abstract: THE PROPOSED RULE WILL DEFINE THE PROCESS AND PROCEDURES WHEREBY SPONSORS OF DRUGS FOR RARE DISEASE OR CONDITIONS MAY ACCESS THE INCENTIVES OF THE ACT FOR WRITTEN RECOMMENDATIONS FOR CONDUCTING CLINICAL TESTING, THE CRITERIA AND PROCESS FOR OBTAINING DESIGNATED ORPHAN DRUG STATUS, AND PROCESS FOR OBTAINING EXCLUSIVE MARKETING APPROVAL FOR A DESIGNATED ORPHAN DRUG.

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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:

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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: 1

table that charts list of burden

IC Title	Form No.	Form Name
ORPHAN DRUG REGULATIONS - NPRM

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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:

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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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 08/30/1991

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