2017-10967. Information Collection: “10 CFR Part 35, Medical Use of Byproduct Material”

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, “10 CFR part 35, Medical Use of Byproduct Material.”

DATES:

Submit comments by June 29, 2017.

ADDRESSES:

Submit comments directly to the OMB reviewer at: Aaron Szabo, Desk Officer, Office of Information and Regulatory Affairs, OMB clearance number 3150-0010, 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-2017-0013 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 Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0013. A copy of the collection of information and related instructions may be obtained without charge by accessing Docket ID NRC-2017-0013 on this Web site.
• 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 is available in ADAMS under Accession No. ML16333A028.
• 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, “10 CFR part 35, Medical Use of Byproduct Material.” 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 February 1, 2017 (82 FR 8959).

1. The title of the information collection: “10 CFR part 35, Medical Use of Byproduct Material.”

2. OMB approval number: 3150-0010.

3. Type of submission: Extension.

4. The form number if applicable: N/A.

5. How often the collection is required or requested: Reports of medical events, doses to an embryo/fetus or nursing child, or leaking source are reportable on occurrence. A specialty board certifying entity desiring to be recognized by the NRC must submit a one-time request for recognition and infrequently revise the information.

6. Who will be required or asked to respond: Physicians and medical institutions holding an NRC license authorizing the administration of byproduct material or radiation from this material to humans for medical use. A specialty board certification entity desiring to have its certifying process and board certificate recognized by the NRC.

7. The estimated number of annual responses: 276,359 ((NRC: 36,313 + 962 recordkeepers = 37,275) + (Agreement States: 232,925 + 6,157 recordkeepers + 2 specialty certification entity = 239,084)).

8. The estimated number of annual respondents: 7,121(NRC: 962 + Agreement states 6,157 + 2 specialty certification entities).

9. An estimate of the total number of hours needed annually to comply with the information collection requirement or request: 1,073,224 hours (NRC Licensees 145,195 hrs. + Agreement States 928,027 hrs. + specialty certifying entities 2 hrs.).

10. Abstract: “10 CFR part 35, Medical Use of Byproduct Material,” contains NRC's requirements and provisions for the medical use of byproduct material and for issuance of specific licenses authorizing the medical use of this material. These requirements and provisions provide for the radiation safety of workers, the general public, patients, and human research subjects. Part 35 contains mandatory requirements that apply to NRC licensees authorized to administer byproduct material or radiation therefrom to humans for medical use. These requirements also provide voluntary provisions for specialty boards to apply to have their certification processes recognized by the NRC so that their board certified individuals can use the certifications as proof of training and experience.

Dated at Rockville, Maryland, this 23rd day of May 2017.

For the Nuclear Regulatory Commission.

David Cullison,

NRC Clearance Officer, Office of the Chief Information Officer.