# Deposit of Biological Materials
**ACTION:**
Proposed collection; comment request.
**SUMMARY:**
The United States Patent and Trademark Office (USPTO), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
**DATES:**
Written comments must be submitted on or before October 2, 2000.
**ADDRESSES:**
Direct all written comments to Thao P. Nguyen, Acting Records Officer, Office of Data Management, Data Administration Division, (703) 308-7397, USPTO, Suite 310, 2231 Crystal Drive, Washington, DC 20231.
**FOR FURTHER INFORMATION CONTACT:**
Requests for additional information should be directed to Robert J. Spar, United States Patent and Trademark Office (USPTO), Washington, DC 20231, by telephone at (703)305-9285.
**SUPPLEMENTARY INFORMATION:**
**I. Abstract**
This collection is required by 35 USC 2(b) and 37 CFR Ch. 1, Subpart G, 1.801-809. Every patent must contain a description of the invention sufficient to enable a person (knowledgeable in the relevant science) to make and use the invention as required by 35 USC 112, first paragraph. When the invention involves a biological material, sometimes words alone cannot sufficiently describe how to make and use the invention in a reproducible or repeatable manner. In such cases, the required biological material must either be known and readily (and continually) available, or be deposited in a suitable depository to meet the enablement and written description requirements of 35 USC 112, first paragraph. When a deposit is necessary, the USPTO collects information to determine whether the depositor is in compliance with the patent statute. This includes a statement proving notification to the interested public on where to obtain samples of the deposits. A viability statement showing that the biological material was tested by the depository, and is a viable or acceptable deposit, must also be submitted to the USPTO.
**II. Method of Collection**
By mail, facsimile, or hand carry when the applicant or agent files a patent application with the United States Patent and Trademark Office (USPTO) or submits subsequent papers during the prosecution of the application to the USPTO.
**III. Data**
*OMB Number:* 0651-0022.
*Form Number:* N/A.
*Type of Review:* Extension of a currently approved collection.
*Affected Public: * Individuals or Households, Business or Other Non-Profit, Not-For-Profit Institutions, and the Federal Government.
*Estimated Number of Respondents: * 3,300 per year for deposited materials and 0.25 per year for depository approval.
*Estimated Time Per Response: * One hour per application for deposited materials and five hours per application for depository approval.
*Estimated Total Annual Respondent Burden Hours:* 3,301 hours per year.
*Estimated Total Annual Respondent Cost Burden: * $99,218.75 per year to submit the information to the USPTO. Additionally, depositories charge fees to depositors; all depositories charge about the same rates for their services. For example, the American Type Culture Collection (ATCC), one of the recognized patent depositories, charges $1,100 for storage and informing, and $150 for viability testing of microorganisms.
| Item | Estimated time for response in hours | Estimated annual burden hours | Estimated annual responses |
| --- | --- | --- | --- |
| Deposited Materials | 1 | 3,300 | 3,300 |
| Depository Approval | 5 | 1.25 | 0.25 |
| Total | | 3,301 | 3,301 |
**IV. Request for Comments**
*Comments are invited on:* (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, *e.g.* , the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized or included in the request for OMB approval of this information collection; they also will become a matter of public record.
Dated: July 28, 2000.
Thao P. Nguyen,
Acting Records Officer, USPTO, Office of Data Management, Data Administration Division.