83 FR 18576 - Submission for OMB Review; 30-Day Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 82 (April 27, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 82 (April 27, 2018)
| Page Range | 18576-18579 | |
| FR Document | 2018-08902 |
[Federal Register Volume 83, Number 82 (Friday, April 27, 2018)] [Notices] [Pages 18576-18579] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-08902] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request 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/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, [email protected] or by fax to 202-395-6974, Attention: Desk Officer for NIH. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Michael Montello, Pharm.D., Shanda Finnigan, MPH, RN, CCRC or Jacquelyn Goldberg, JD, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, 9609 Medical Center Drive, Rockville, MD 20850 or call non-toll-free number (240-276-6080) or email your request, including your address to: [email protected]. SUPPLEMENTARY INFORMATION: This proposed information collection was previously published in the Federal Register on February 21, 2018, page 7483 (83 FR 7483) and allowed 60 days for public comment. No public comments were received. The National Cancer Institute (NCI), National Institutes of Health, 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 OMB control number. In compliance with Section 3507(a)(1)(D) of 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. Proposed Collection: CTEP Branch and Support Contracts Forms and Surveys, 0925-0753 Expiration Date 06/30/2020, REVISION, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: 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 [[Page 18577]] initiating and managing clinical trials is 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, FDA regulations pertaining to the sponsor of clinical trials and the selection of qualified investigators under 21 CRF 312.53). Information is also collected through surveys to assess satisfaction, provide feedback to guide improvements with processes and technology, and assess health professional's interests in clinical trials. To increase efficiencies, reduce administrative burden and cost, CTEP has requested consolidation of their current OMB submission. Consolidation is justified because although the various branches and contracts are responsible for distinct services, the processes that support the NCI and participating clinical sites efforts are intertwined. This revision of the previous submission includes changes to the NCI CIRB and CTSU form collections and integrates the Clinical Trials Monitoring Branch (CTMB) and Pharmaceutical Management Branch (PMB) form collections related to site audit and clinical investigator and key clinical site staff registration. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 112,798. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Form name Type of Number of responses per per response Total annual respondent respondents respondent (in hours) burden 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 Practitioner. (Attachment A03). Site Addition Form (Attachment Health Care 80 12 10/60 160 A04). Practitioner. CTSU Roster Update Form Health Care 600 1 5/60 50 (Attachment A05). 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. Site Initiated Data Update Health Care 2 12 10/60 4 Form (Attachment A08). Practitioner. Data Clarification Form Health Care 150 24 10/60 600 (Attachment A09). Practitioner. RTOG 0834 CTSU Data Health Care 12 76 10/60 152 Transmittal Form (Attachment Practitioner. A10). CTSU Generic Data Transmittal Health Care 5 12 10/60 10 Form (Attachment A12). Practitioner. 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 System Access Request Health Care 180 1 20/60 60 Form (Attachment A17). 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 and Health Care 400 10 30/60 2,000 PDF (Attachment A20). Practitioner. CTSU PDF Signature Form Health Care 400 10 10/60 667 (Attachment A21). Practitioner. NCI CIRB AA & DOR between the Participants.... 50 1 15/60 13 NCI 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 Health Care 80 1 60/60 80 (Attachment B10). Practitioner. CIRB IR Application for Exempt Health Care 4 1 30/60 2 Studies (Attachment B11). Practitioner. CIRB Amendment Review Health Care 400 1 15/60 100 Application (Attachment B12). Practitioner. CIRB Ancillary Studies Health Care 1 1 60/60 1 Application. Practitioner. (Attachment B13).............. CIRB Continuing Review Health Care 400 1 15/60 100 Application. Practitioner. (Attachment B14).............. Adult IR of Cooperative Group Board Members... 65 1 180/60 195 Protocol (Attachment B15). [[Page 18578]] Pediatric IR of Cooperative Board Members... 15 1 180/60 45 Group Protocol (Attachment B16). NCI Adult/Pediatric Continuing Board Members... 275 1 60/60 275 Review of 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 Board Members... 348 1 30/60 174 Review (Attachment B23). Pediatric Expedited Amendment Board Members... 140 1 30/60 70 Review (Attachment B24). Adult Expedited Continuing Board Members... 140 1 30/60 70 Review (Attachment B25). Pediatric Expedited Continuing Board Members... 36 1 30/60 18 Review (Attachment B26). Adult Cooperative Group Health Care 30 1 60/60 30 Response to CIRB Review Practitioner. (Attachment B27). 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- Board Members... 400 1 10/60 67 Determination of UP or SCN (Attachment B31). Reviewer Worksheet -CIRB Board Members... 100 1 15/60 25 Statistical Reviewer Form (Attachment B32). CIRB Application for Health Care 100 1 30/60 50 Translated Documents Practitioner. (Attachment B33). Reviewer Worksheet of Board Members... 100 1 15/60 25 Translated Documents (Attachment B34). Reviewer Worksheet of Board Members... 20 1 15/60 5 Recruitment Material (Attachment B35). Reviewer Worksheet Expedited Board Members... 20 1 15/60 5 Study Closure Review (Attachment B36). Reviewer Worksheet of Board Members... 5 1 30/60 3 Expedited IR (Attachment B38). Annual Signatory Institution Health Care 400 1 40/60 267 Worksheet About Local Context Practitioner. (Attachment B40). 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 20/60 1,600 Local Context (Attachment Practitioner. B42). Study Closure or Transfer of Health Care 1,680 1 20/60 560 Study Review Responsibility Practitioner. (Attachment B43). Unanticipated Problem or Health Care 360 1 20/60 120 Serious or Continuing Practitioner. Noncompliance Reporting Form (Attachment (B44). Change of Signatory Health Care 120 1 20/60 40 Institution PI Form Practitioner. (Attachment B45). Request Waiver of Assent Form ................ 60 1 20/60 20 (Attachment B46). CTSU OPEN Survey (Attachment Health Care 60 1 15/60 15 C03). Practitioner. CIRB Customer Satisfaction Participants.... 600 1 15/60 150 Survey (Attachment C04). Follow-up Survey Participants/ 300 1 15/60 75 (Communication Audit) Board Members. (Attachment C05). CIRB Board Member Annual Board Members... 60 1 15/60 15 Assessment Survey (Attachment C07). PIO Customer Satisfaction Health Care 60 1 5/60 5 Survey (Attachment C08). Practitioner. Concept Clinical Trial Survey Health Care 500 1 5/60 42 (Attachment C09). Practitioner. Prospective Clinical Trial Health Care 1,000 1 1/60 17 Survey (Attachment C10). Practitioner. Low Accrual Clinical Trial Health Care 1,000 1 1/60 17 Survey (Attachment C11). Practitioner. [[Page 18579]] Audit Scheduling Form Group/CTMS Users 152 5 21/60 266 (Attachment D01). Preliminary Audit Findings Auditor......... 152 5 10/60 127 Form (Attachment D02). Audit Maintenance Form Group/CTMS Users 152 5 9/60 114 (Attachment D03). Final Audit Finding Report Group/CTMS Users 75 11 1,098/60 15,098 Form (Attachment D04). Follow-up Form (Attachment Group/CTMS Users 75 7 27/60 236 D05). Roster Maintenance Form CTMS Users...... 5 1 18/60 2 (Attachment D06). Final Report and CAPA Request CTMS Users...... 12 9 1,800/60 3240 Form (Attachment D07). NCI/DCTD/CTEP FDA Form 1572 Physician....... 23,000 1 15/60 5,750 for Annual Submission (Attachment E01). NCI/DCTD/CTE Biosketch Physician; 33,000 1 120/60 66,000 (Attachment E02). Health Care Practitioner. NCI/DCTD/CTEP Financial Physician; 33,000 1 5/60 2,750 Disclosure Form (Attachment Health Care E03). Practitioner. NCI/DCTD/CTEP Agent Shipment Physician....... 23,000 1 10/60 3,833 Form (ASF) (Attachment E04). --------------------------------------------------------------- Totals.................... ................ 136,487 207,989 .............. 112,838 ---------------------------------------------------------------------------------------------------------------- Dated: April 12, 2018. Karla Bailey, Project Clearance Liaison, National Cancer Institute, National Institutes of Health. [FR Doc. 2018-08902 Filed 4-26-18; 8:45 am] BILLING CODE 4140-01-P
![18576 Federal Register / Vol. 83, No. 82 / Friday, April 27, 2018 / Notices
biospecimen inventories must register biospecimens among investigators is All the data collected from use of
for an account. effective. The primary uses of the NICHD DASH except for information
Information will be collected from information collected from Users by provided in the annual progress reports
those wishing to create an account, NICHD will be to: are for the purposes of internal
• Communicate with the Users with administrative management of NICHD
sufficient to identify them as unique
regards to their data submission, data DASH. Information gathered through
Users. Those submitting or requesting
requests and biospecimen requests the annual progress reports may be used
data and/or biospecimen inventories • Monitor data submissions, data
will be required to provide additional in publications describing performance
requests and biospecimen requests
supporting information to ensure proper • Notify interested recipients of updates of the DASH system.
use and security of NICHD DASH study to data and biospecimen inventories OMB approval is requested for 3
data and biospecimen inventories. The stored in NICHD DASH years. There are no costs to respondents
information collected is limited to the • Help NICHD understand the use of other than their time. The total
essential data required to ensure the NICHD DASH study data and estimated annualized burden hours are
management of Users in NICHD DASH biospecimen inventories by the 204.
is efficient and the sharing of data and research community
ESTIMATED ANNUALIZED BURDEN HOURS
Average time
Number of Frequency of Total annual
Type of form per response
respondents response burden hour
(in hours)
User Registration ............................................................................................. 200 1 5/60 17
Data and Biospecimen Inventory Submission ................................................. 36 1 2 72
Data Request ................................................................................................... 60 1 1 60
Biospecimen Request ...................................................................................... 36 1 1 36
Data Use Annual Progress Report .................................................................. 60 1 10/60 10
Biospecimen Use Annual Progress Report ..................................................... 36 1 10/60 6
Institutional Certification Template .................................................................. 36 1 5/60 3
Total .......................................................................................................... 200 200 ........................ 204
Dated: April 17, 2018. ADDRESSES: Written comments and/or revised, or implemented on or after
Jennifer M. Guimond, suggestions regarding the item(s) October 1, 1995, unless it displays a
Project Clearance Liaison, Eunice Kennedy contained in this notice, especially currently valid OMB control number.
Shriver, National Institute of Child Health regarding the estimated public burden In compliance with Section
and Human Development, National Institutes and associated response time, should be 3507(a)(1)(D) of the Paperwork
of Health. directed to the: Office of Management Reduction Act of 1995, the National
[FR Doc. 2018–08901 Filed 4–26–18; 8:45 am] and Budget, Office of Regulatory Affairs, Institutes of Health (NIH) has submitted
BILLING CODE 4140–01–P OIRA_submission@omb.eop.gov or by to the Office of Management and Budget
fax to 202–395–6974, Attention: Desk (OMB) a request for review and
Officer for NIH. approval of the information collection
DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: To listed below.
HUMAN SERVICES request more information on the Proposed Collection: CTEP Branch
proposed project or to obtain a copy of and Support Contracts Forms and
National Institutes of Health the data collection plans and Surveys, 0925–0753 Expiration Date 06/
Submission for OMB Review; 30-Day instruments, contact: Michael Montello, 30/2020, REVISION, National Cancer
Comment Request Pharm.D., Shanda Finnigan, MPH, RN, Institute (NCI), National Institutes of
CCRC or Jacquelyn Goldberg, JD, Cancer Health (NIH).
CTEP Branch and Support Contracts Therapy Evaluation Program, Division Need and Use of Information
Forms and Surveys (National Cancer of Cancer Treatment and Diagnosis, Collection: The National Cancer
Institute) 9609 Medical Center Drive, Rockville, Institute (NCI) Cancer Therapy
AGENCY: National Institutes of Health, MD 20850 or call non-toll-free number Evaluation Program (CTEP) and the
HHS. (240–276–6080) or email your request, Division of Cancer Prevention (DCP)
ACTION: Notice. including your address to: ctsucontact@ fund an extensive national program of
westat.com. cancer research, sponsoring clinical
SUMMARY: In compliance with the SUPPLEMENTARY INFORMATION: This trials in cancer prevention, symptom
Paperwork Reduction Act of 1995, the proposed information collection was management and treatment for qualified
National Institutes of Health (NIH) has previously published in the Federal clinical investigators. As part of this
submitted to the Office of Management Register on February 21, 2018, page effort, CTEP implements programs to
and Budget (OMB) a request for review 7483 (83 FR 7483) and allowed 60 days register clinical site investigators and
daltland on DSKBBV9HB2PROD with NOTICES
and approval of the information for public comment. No public clinical site staff, and to oversee the
collection listed below. comments were received. The National conduct of research at the clinical sites.
DATES: Comments regarding this Cancer Institute (NCI), National CTEP and DCP also oversee two support
information collection are best assured Institutes of Health, may not conduct or programs, the NCI Central Institutional
of having their full effect if received sponsor, and the respondent is not Review Board (CIRB) and the Cancer
within 30-days of the date of this required to respond to, an information Trial Support Unit (CTSU). The
publication. collection that has been extended, combined systems and processes for
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![Federal Register / Vol. 83, No. 82 / Friday, April 27, 2018 / Notices 18579
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average Total
Number of
Number of burden per annual
Form name Type of respondent responses per
respondents response burden
respondent (in hours) hours
Audit Scheduling Form (Attachment D01) ....... Group/CTMS Users ........... 152 5 21/60 266
Preliminary Audit Findings Form (Attachment Auditor ............................... 152 5 10/60 127
D02).
Audit Maintenance Form (Attachment D03) .... Group/CTMS Users ........... 152 5 9/60 114
Final Audit Finding Report Form (Attachment Group/CTMS Users ........... 75 11 1,098/60 15,098
D04).
Follow-up Form (Attachment D05) .................. Group/CTMS Users ........... 75 7 27/60 236
Roster Maintenance Form (Attachment D06) CTMS Users ...................... 5 1 18/60 2
Final Report and CAPA Request Form (At- CTMS Users ...................... 12 9 1,800/60 3240
tachment D07).
NCI/DCTD/CTEP FDA Form 1572 for Annual Physician ........................... 23,000 1 15/60 5,750
Submission (Attachment E01).
NCI/DCTD/CTE Biosketch (Attachment E02) Physician; Health Care 33,000 1 120/60 66,000
Practitioner.
NCI/DCTD/CTEP Financial Disclosure Form Physician; Health Care 33,000 1 5/60 2,750
(Attachment E03). Practitioner.
NCI/DCTD/CTEP Agent Shipment Form Physician ........................... 23,000 1 10/60 3,833
(ASF) (Attachment E04).
Totals ........................................................ ............................................ 136,487 207,989 ........................ 112,838
Dated: April 12, 2018. Contact Person: Malaya Chatterjee, Ph.D., Dated: April 23, 2018.
Karla Bailey, Scientific Review Officer, Center for Sylvia L. Neal,
Project Clearance Liaison, National Cancer Scientific Review, National Institutes of Program Analyst, Office of Federal Advisory
Institute, National Institutes of Health. Health, 6701 Rockledge Drive, Room 6192, Committee Policy.
MSC 7804, Bethesda, MD 20892, (301) 806–
[FR Doc. 2018–08902 Filed 4–26–18; 8:45 am] [FR Doc. 2018–08843 Filed 4–26–18; 8:45 am]
2515, chatterm@csr.nih.gov.
BILLING CODE 4140–01–P BILLING CODE 4140–01–P
Name of Committee: Immunology
Integrated Review Group; Cellular and
Molecular Immunology—B Study Section.
DEPARTMENT OF HEALTH AND Date: May 23–24, 2018. DEPARTMENT OF HEALTH AND
HUMAN SERVICES Time: 8:30 a.m. to 5:00 p.m. HUMAN SERVICES
Agenda: To review and evaluate grant
National Institutes of Health applications. National Institutes of Health
Place: Double Tree by Hilton Washington/
Center for Scientific Review; Notice of Silver Spring, 8727 Colesville Road, Silver Center for Scientific Review; Notice of
Closed Meetings Spring, MD 20910. Closed Meeting
Contact Person: Betty Hayden, Ph.D.,
Pursuant to section 10(d) of the Pursuant to section 10(d) of the
Scientific Review Officer, Center for
Federal Advisory Committee Act, as Scientific Review, National Institutes of Federal Advisory Committee Act, as
amended, notice is hereby given of the Health, 6701 Rockledge Drive, Room 4206, amended, notice is hereby given of the
following meetings. MSC 7812, Bethesda, MD 20892, 301–435– following meeting.
The meetings will be closed to the 1223, haydenb@csr.nih.gov. The meeting will be closed to the
public in accordance with the Name of Committee: Center for Scientific public in accordance with the
provisions set forth in sections Review Special Emphasis Panel; provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Bioengineering Sciences and Technologies: 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and AREA Review. as amended. The grant applications and
the discussions could disclose Date: May 24, 2018. the discussions could disclose
confidential trade secrets or commercial Time: 9:00 a.m. to 6:00 p.m. confidential trade secrets or commercial
property such as patentable material, Agenda: To review and evaluate grant property such as patentable material,
applications.
and personal information concerning and personal information concerning
Place: National Institutes of Health, 6701
individuals associated with the grant Rockledge Drive, Bethesda, MD 20892 individuals associated with the grant
applications, the disclosure of which (Virtual Meeting). applications, the disclosure of which
would constitute a clearly unwarranted Contact Person: David Filpula, Ph.D., would constitute a clearly unwarranted
invasion of personal privacy. Scientific Review Officer, Center for invasion of personal privacy.
Name of Committee: Center for Scientific Scientific Review, National Institutes of Name of Committee: Center for Scientific
Review Special Emphasis Panel; Metabolic Health, 6701 Rockledge Drive, Room 6181, Review Special Emphasis Panel; AIDS and
daltland on DSKBBV9HB2PROD with NOTICES
Reprogramming to Improve Immunotherapy. MSC 7892, Bethesda, MD 20892, 301–435– Related Research Special Topics.
Date: May 22, 2018. 2902, filpuladr@mail.nih.gov. Date: April 26, 2018.
Time: 11:00 a.m. to 3:00 p.m. (Catalogue of Federal Domestic Assistance Time: 1:30 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant Program Nos. 93.306, Comparative Medicine; Agenda: To review and evaluate grant
applications. 93.333, Clinical Research, 93.306, 93.333, applications.
Place: National Institutes of Health, 6701 93.337, 93.393–93.396, 93.837–93.844, Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892 93.846–93.878, 93.892, 93.893, National Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call). Institutes of Health, HHS) (Telephone Conference Call).
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Document Created: 2018-04-27 01:46:23
Document Modified: 2018-04-27 01:46:23
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| Contact | To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Michael Montello, Pharm.D., Shanda Finnigan, MPH, RN, CCRC or Jacquelyn Goldberg, JD, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, 9609 Medical Center Drive, Rockville, MD 20850 or call non-toll-free number (240-276-6080) or | |
| FR Citation | 83 FR 18576 |
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