Guidance for Industry (GFI): Nonproprietary Naming of Biological Products

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Nonproprietary Naming of Biological Products SS 2017.pdf	Supporting Statement A	Uploaded 2017-01-12	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
225096	GFI: Nonproprietary Naming of Biological Products	Other-Agency Guidance	New

ICR Details

OMB Control No:	ICR Reference No: 201701-0910-005
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry (GFI): Nonproprietary Naming of Biological Products
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OIRA Conclusion Action: Withdrawn	Conclusion Date: 07/03/2018
	Date Received in OIRA: 01/12/2017
Terms of Clearance:

table that charts list comparision

	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: This ICR collects information from applicants and application holders of biological products licensed under the Public Health Service Act (PHS Act). Respondents submit information proposing a suffix composed of four lowercase letters for use as the suffix included in the proper name. The proper name is designated by FDA in the license for biological products licensed under the PHS Act. An applicant may submit up to 10 proposed suffixes, in the order of the applicant’s preference. FDA recommends that respondents include supporting analyses of the proposed suffixes for FDA’s consideration. Under this naming convention, the nonproprietary name designated for each originator biological product, related biological product, and biosimilar product will be a proper name that is a combination of core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters. This naming convention is applicable to biological products previously licensed and newly licensed under section 351(a) or 351(k) of the PHS Act. This naming convention will facilitate pharmacovigilance for multiple biological products containing related drug substances when other means to track a specific dispensed product are not readily accessible or available, as described in the guidance.

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Authorizing Statute(s): PL: Pub.L. 78 - 410 351(a), 351(k) Name of Law: Public Health Service Act; Biological Products
  

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:
	80 FR 52296	08/28/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 1234	01/10/2017
Did the Agency receive public comments on this ICR? Yes

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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
GFI: Nonproprietary Naming of Biological Products

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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 information collection associated with agency guidance.

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Annual Cost to Federal Government: $116,113

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: 01/12/2017

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