2017-27407. Information Collection: Registration Certificate-In Vitro Testing With Byproduct Material Under General License

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Notice of submission to the Office of Management and Budget; request for comment.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, NRC Form 483, Registration Certificate—“In Vitro Testing With Byproduct Material Under General License.”

DATES:

Submit comments by January 19, 2018.

ADDRESSES:

Submit comments directly to the OMB reviewer at: Brandon DeBruhl, Desk Officer, Office of Information and Regulatory Affairs (3150-0038), NEOB-10202, Office of Management and Budget, Washington, DC 20503; telephone: [phone], email: [e-mail].

FOR FURTHER INFORMATION CONTACT:

David Cullison, NRC Clearance Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: [phone]; email: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Obtaining Information and Submitting Comments

A. Obtaining Information

Please refer to Docket ID NRC-2017-0166 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal rulemaking website: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0166.
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/​reading-rm/​adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [e-mail]. The supporting statement and the revised NRC Form 483 are available in ADAMS under Accession Nos. ML17348B437 and ML17300B398, respectively.
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
• NRC's Clearance Officer: A copy of the collection of information and related instructions may be obtained without charge by contacting the NRC's Clearance Officer, David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: [phone]; email: [e-mail].

B. Submitting Comments

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at http://www.regulations.gov as well as entering the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the OMB, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.

Background

Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC recently submitted a request for renewal of an existing collection of information to OMB for review entitled, NRC Form 483, “Registration Certificate—In Vitro Testing With Byproduct Material Under General License.” The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

The NRC published a Federal Register notice with a 60-day comment period on this information collection on August 28, 2017 (82 FR 40809).

1. The title of the information collection: NRC Form 483, Registration Certificate—In Vitro Testing With Byproduct Material Under General License.

2. OMB approval number: 3150-0038.

3. Type of submission: Extension.

4. The form number if applicable: NRC Form 483.

5. How often the collection is required or requested: There is a one-time submittal of information to receive a validated copy of the NRC Form 483 with an assigned registration number. In addition, any changes in the information reported on the NRC Form 483 must be reported in writing to the NRC within 30 days after the effective date of the change.

6. Who will be required or asked to respond: Any physician, veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital which desires a general license to receive, acquire, possess, transfer, or use specified units of byproduct material in certain in vitro clinical or laboratory tests.

7. The estimated number of annual responses: 6.

8. The estimated number of annual respondents: 6.

9. An estimate of the total number of hours needed annually to comply with the information collection requirement or request: 1.12 hours.

10. Abstract: Section 31.11 of Title 10 of the Code of Federal Regulations (10 CFR), established a general license authorizing any physician, clinical laboratory, veterinarian in the practice of veterinary medicine, or hospital to possess certain small quantities of byproduct material for in vitro clinical or laboratory test not involving the internal or external administration of the byproduct material or the radiation therefrom to human beings or animals. Possession of byproduct material under 10 CFR 31.11 is not authorized until the physician, clinical laboratory, veterinarian in the practice of veterinary medicine, or hospital has filed the NRC Form 483 and received from the Commission a validated copy of the NRC Form 483 with a registration number. The licensee can use the validated copy of the NRC Form 483 to obtain byproduct material from a specifically licensed supplier. The NRC incorporates this information into a database which is used to verify that a general licensee is authorized to receive the byproduct material.

Dated at Rockville, Maryland, this 15th day of December, 2017.

For the Nuclear Regulatory Commission.

David Cullison,

NRC Clearance Officer, Office of the Chief Information Officer.