[Federal Register Volume 87, Number 169 (Thursday, September 1, 2022)]
[Notices]
[Pages 53752-53754]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18853]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request Cancer Therapy 
Evaluation Program (CTEP) Branch and Support Contracts Forms and 
Surveys (National Cancer Institute)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the 
National Institutes of Health (NIH) has submitted to the Office of 
Management and Budget (OMB) a request for review and approval of the 
information collection listed below.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30-days of the date of 
this publication.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, submit comments in writing, or 
request more information on the proposed project, contact: Michael 
Montello, Cancer Therapy Evaluation Program, Division of Cancer 
Treatment and Diagnosis, National Cancer Institute, 9609 Medical Center 
Drive, Bethesda, Maryland 20892 or call non-toll-free number (240) 276-
6080 or email your request, including your address to: 
[email protected]. Formal requests for additional plans and 
instruments must be requested in writing.

SUPPLEMENTARY INFORMATION: This proposed information collection was 
published in the Federal Register on May 31, 2022 (Vol. 87, No. 104, P. 
32427) and allowed 60 days for public comment. No public comments were 
received. The purpose of this notice is to allow an additional 30 days 
for public comment. The National Cancer Institute (NCI), National 
Institutes of Health (NIH), may not conduct or sponsor, and the 
respondent is not required to respond to, an information collection 
that has been extended, revised, or implemented on or after October 1, 
1995, unless it displays a currently valid Office of Management and 
Budget (OMB) control number.
    In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction 
Act of 1995, NIH has submitted to OMB a request for review and approval 
of the information collection listed below.
    Proposed Collection: Cancer Therapy Evaluation Program (CTEP) 
Support Contracts Forms and Survey (NCI) (0925-0753), Expiration Date 
05/31/2024, REVISION, National Cancer Institute (NCI), National 
Institutes of Health (NIH).
    Need and Use of Information Collection: This revision removes one 
form, adds one new form, revises three forms, and includes an updated 
Privacy Impact Assessment. The National Cancer Institute (NCI) Cancer 
Therapy Evaluation Program (CTEP) and the Division of Cancer Prevention 
(DCP) fund an extensive national program of cancer research, sponsoring 
clinical trials in cancer prevention, symptom management, and treatment 
for qualified clinical investigators. As part of this effort, CTEP 
implements programs to register clinical site investigators and 
clinical site staff and to oversee the conduct of research at the 
clinical sites. CTEP and DCP also oversee two support programs, the NCI 
Central Institutional Review Board (CIRB) and the Cancer Trial Support 
Unit (CTSU). The combined systems and processes for initiating and 
managing clinical trials are termed the Clinical Oncology Research 
Enterprise (CORE) and represents an integrated set of information 
systems and processes which support investigator registration, trial 
oversight, patient enrollment, and clinical data collection. The 
information collected is required to ensure compliance with applicable 
federal regulations governing the conduct of human subjects research 
(45 CFR 46 and 21 CRF 50), and when CTEP acts as the Investigational 
New Drug (IND) holder (Food and Drug Administration (FDA) regulations 
pertaining to the sponsor of clinical trials and the selection of 
qualified investigators (21 CRF 312.53). Survey collections assess 
satisfaction and provide feedback to guide improvements with processes 
and technology. OMB approval is requested for 3 years. There are no 
costs to respondents other than their time. The total estimated 
annualized burden is 151,769 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                          Average       Total
                                                           Number of       Number of     burden per     annual
            Form name               Type of respondent    respondents    responses per    response      burden
                                                                          respondent     (in hours)     hours
----------------------------------------------------------------------------------------------------------------
CTSU IRB/Regulatory Approval       Health Care                   2,444              12         2/60          978
 Transmittal Form (Attachment       Practitioner.
 A01).
CTSU IRB Certification Form        Health Care                   2,444              12        10/60        4,888
 (Attachment A02).                  Practitioner.
Withdrawal from Protocol           Health Care                     279               1        10/60           47
 Participation Form (Attachment     Practitioner.
 A03).
Site Addition Form (Attachment     Health Care                      80              12        10/60          160
 A04).                              Practitioner.
CTSU Request for Clinical          Health Care                     360               1        10/60           60
 Brochure (Attachment A06).         Practitioner.
CTSU Supply Request Form           Health Care                      90              12        10/60          180
 (Attachment A07).                  Practitioner.
RTOG 0834 CTSU Data Transmittal    Health Care                      12              76        10/60          152
 Form (Attachment A10).             Practitioner.

[[Page 53753]]

 
CTSU Patient Enrollment            Health Care                      12              12        10/60           24
 Transmittal Form (Attachment       Practitioner.
 A15).
CTSU Transfer Form (Attachment     Health Care                     360               2        10/60          120
 A16).                              Practitioner.
CTSU OPEN Rave Request Form        Health Care                      30              21        10/60          105
 (Attachment A18).                  Practitioner.
CTSU LPO Form Creation             Health Care                       5               2       120/60           20
 (Attachment A19).                  Practitioner.
CTSU Site Form Creation            Health Care                     400              10        30/60        2,000
 (Attachment A20).                  Practitioner.
CTSU Electronic Signature Form     Health Care                     400              10        10/60          667
 (Attachment A21).                  Practitioner.
CTSU CLASS Course Setup Form       Health Care                      10               2        20/60            7
 (Attachment A22).                  Practitioner.
NCI CIRB AA & DOR between the NCI  Participants.......              50               1        15/60           13
 CIRB and Signatory Institution
 (Attachment B01).
NCI CIRB Signatory Enrollment      Participants.......              50               1        15/60           13
 Form (Attachment B02).
CIRB Board Member Application      Board Member.......             100               1        30/60           50
 (Attachment B03).
CIRB Member COI Screening          Board Members......             100               1        15/60           25
 Worksheet (Attachment B08).
CIRB COI Screening for CIRB        Board Members......              72               1        15/60           18
 meetings (Attachment B09).
CIRB IR Application (Attachment    Health Care                      80               1        60/60           80
 B10).                              Practitioner.
CIRB IR Application for Exempt     Health Care                       4               1        30/60            2
 Studies (Attachment B11).          Practitioner.
CIRB Amendment Review Application  Health Care                     400               1        15/60          100
 (Attachment B12).                  Practitioner.
CIRB Ancillary Studies             Health Care                       1               1        60/60            1
 Application (Attachment B13).      Practitioner.
CIRB Continuing Review             Health Care                     400               1        15/60          100
 Application (Attachment B14).      Practitioner.
Adult IR of Cooperative Group      Board Members......              65               1       180/60          195
 Protocol (Attachment B15).
Pediatric IR of Cooperative Group  Board Members......              15               1       180/60           45
 Protocol (Attachment B16).
Adult Continuing Review of         Board Members......             275               1        60/60          275
 Cooperative Group Protocol
 (Attachment B17).
Adult Amendment of Cooperative     Board Members......              40               1       120/60           80
 Group Protocol (Attachment B19).
Pediatric Amendment of             Board Members......              25               1       120/60           50
 Cooperative Group Protocol
 (Attachment B20).
Pharmacist's Review of a           Board Members......              50               1       120/60          100
 Cooperative Group Study
 (Attachment B21).
Adult Expedited Amendment Review   Board Members......             348               1        30/60          174
 (Attachment B23).
Pediatric Expedited Amendment      Board Members......             140               1        30/60           70
 Review (Attachment B24).
Adult Expedited Continuing Review  Board Members......             140               1        30/60           70
 (Attachment B25).
Pediatric Expedited Continuing     Board Members......              36               1        30/60           18
 Review (Attachment B26).
Adult Cooperative Group Response   Health Care                      30               1        60/60           30
 to CIRB Review (Attachment B27).   Practitioner.
Pediatric Cooperative Group        Health Care                       5               1        60/60            5
 Response to CIRB Review            Practitioner.
 (Attachment B28).
Adult Expedited Study Chair        Board Members......              40               1        30/60           20
 Response to Required
 Modifications (Attachment B29).
Reviewer Worksheet--Determination  Board Members......             400               1        10/60           67
 of UP or SCN (Attachment B31).
Reviewer Worksheet--CIRB           Board Members......             100               1        15/60           25
 Statistical Reviewer Form
 (Attachment B32).
CIRB Application for Translated    Health Care                     100               1        30/60           50
 Documents (Attachment B33).        Practitioner.
Reviewer Worksheet of Translated   Board Members......             100               1        15/60           25
 Documents (Attachment B34).
Reviewer Worksheet of Recruitment  Board Members......              20               1        15/60            5
 Material (Attachment B35).
Reviewer Worksheet Expedited       Board Members......              20               1        15/60            5
 Study Closure Review (Attachment
 B36).
Reviewer Worksheet of Expedited    Board Members......               5               1        30/60            3
 IR (Attachment B38).
Annual Signatory Institution       Health Care                     400               1        40/60          267
 Worksheet About Local Context      Practitioner.
 (Attachment B40).

[[Page 53754]]

 
Annual Principal Investigator      Health Care                   1,800               1        20/60          600
 Worksheet About Local Context      Practitioner.
 (Attachment B41).
Study-Specific Worksheet About     Health Care                   4,800               1        15/60        1,200
 Local Context (Attachment B42).    Practitioner.
Study Closure or Transfer of       Health Care                   1,680               1        15/60          420
 Study Review Responsibility        Practitioner.
 (Attachment B43).
Unanticipated Problem or Serious   Health Care                     360               1        20/60          120
 or Continuing Noncompliance        Practitioner.
 Reporting Form (Attachment B44).
Change of Signatory Institution    Health Care                     120               1        20/60           40
 PI Form (Attachment B45).          Practitioner.
Request Waiver of Assent Form      Health Care                      35               1        20/60           12
 (Attachment B46).                  Practitioner.
CIRB Waiver of Consent Request     Health Care                      20               1        15/60            5
 Supplemental Form (Attachment      Practitioner.
 B47).
Review Worksheet CIRB Review for   Board Members......              20               1        60/60           20
 Inclusion of Incarcerated
 Participants (Attachment B48).
Notification of Incarcerated       Health Care                      20               1        20/60            7
 Participant Form (Attachment       Practitioner.
 B49).
CTSU OPEN Survey (Attachment C03)  Health Care                      10               1        15/60            3
                                    Practitioner.
CIRB Customer Satisfaction Survey  Participants.......             600               1        15/60          150
 (Attachment C04).
Follow-up Survey (Communication    Participants/......             300               1        15/60           75
 Audit) (Attachment C05).          Board Members......
CIRB Board Member Annual           Board Members......              60               1        15/60           15
 Assessment Survey (Attachment
 C07).
PIO Customer Satisfaction Survey   Health Care                      60               1         5/60            5
 (Attachment C08).                  Practitioner.
Audit Scheduling Form (Attachment  Health Care                     152               5        21/60          266
 D01).                              Practitioner.
Preliminary Audit Finding Form     Health Care                     152               5        10/60          127
 (Attachment D02).                  Practitioner.
Audit Maintenance Form             Health Care                     152               5         9/60          114
 (Attachment D03).                  Practitioner.
Final Audit finding Report Form    Health Care                      75              11     1,098/60       15,098
 (Attachment D04).                  Practitioner.
Follow-up Form (Attachment D05)..  Health Care                      75               7        27/60          236
                                    Practitioner.
Roster Maintenance Form            Health Care                       5               1        18/60            2
 (Attachment D06).                  Practitioner.
Final Report and CAPA Request      Health Care                      12               9     1,800/60        3,240
 Form (Attachment D07).             Practitioner.
NCI/DCTD/CTEP FDA Form 1572 for    Physician..........          26,500               1        15/60        6,625
 Annual Submission (Attachment
 E01).
NCI/DCTD/CTE Biosketch             Physician; Health            48,000               1       120/60       96,000
 (Attachment E02).                  Care Practitioner.
NCI/DCTD/CTEP Financial            Physician; Health            48,000               1        15/60       12,000
 Disclosure Form (Attachment E03).  Care Practitioner.
NCI/DCTD/CTEP Agent Shipment Form  Physician..........          24,000               1        10/60        4,000
 (ASF) (Attachment E04).
                                                       ---------------------------------------------------------
    Totals.......................  ...................         167,545         235,510  ...........      151,769
----------------------------------------------------------------------------------------------------------------


    Dated: August 26, 2022.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 2022-18853 Filed 8-31-22; 8:45 am]
BILLING CODE 4140-01-P