83_FR_54092 83 FR 53885 - Proposed Collection; 60-Day Comment Request; Investigational Agent Accountability Record Forms in the Conduct of Investigational Trials for the Treatment of Cancer (National Cancer Institute)

83 FR 53885 - Proposed Collection; 60-Day Comment Request; Investigational Agent Accountability Record Forms in the Conduct of Investigational Trials for the Treatment of Cancer (National Cancer Institute)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 207 (October 25, 2018)

Page Range53885-53886
FR Document2018-23313

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Federal Register, Volume 83 Issue 207 (Thursday, October 25, 2018) 
[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Notices]
[Pages 53885-53886]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-23313]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; Investigational 
Agent Accountability Record Forms in the Conduct of Investigational 
Trials for the Treatment of Cancer (National Cancer Institute)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with the requirement of the Paperwork Reduction 
Act of 1995 to provide opportunity for public comment on proposed data 
collection projects, the National Cancer Institute (NCI) will publish 
periodic summaries of proposed projects to be submitted to the Office 
of Management and Budget (OMB) for review and approval.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 60 days of the date of 
this publication.

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: Charles 
Hall, Chief, Pharmaceutical Management Branch, Cancer Therapy 
Evaluation Program, Division of Cancer Diagnosis and Treatment, 
National Cancer Institute, 9609 Medical Center Drive, Bethesda, 
Maryland, 20892 or call non-toll-free number (240) 276-6575 or Email 
your request, including your address to: [email protected]. Formal 
requests for additional plans and instruments must be requested in 
writing.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 requires: Written comments and/or suggestions 
from the public and affected agencies are invited to address one or 
more of the following points: (1) Whether the proposed collection of 
information is necessary for the proper performance of the function of 
the agency, including whether the information will have practical 
utility; (2) The accuracy of the agency's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) Ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) Ways 
to minimizes the burden of the collection of information on those who 
are to respond, including the use of appropriate automated, electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology.
    Proposed Collection Title: Investigational Agent Accountability 
Record Forms in the Conduct of Investigational Trials for the Treatment 
of Cancer, 0925-0613, Expiration Date 3/31/2019, Revision, National 
Cancer Institute (NCI), National Institutes of Health (NIH).
    Need and Use of Information Collection: The U.S. Food and Drug 
Administration (FDA) holds the National Cancer Institute (NCI), 
Division of Cancer Treatment and Diagnosis/Cancer Therapy Evaluation 
Program (NCI/DCTD/CTEP) and the Division of Cancer Prevention (DCP) 
responsible, as a sponsor of investigational drug trials, to assure the 
FDA that systems for accountability are being maintained by 
investigators in its clinical trials program. Data obtained from the 
Investigational Agent Accountability Record Forms (aka. Drug 
Accountability Record Forms--DARF) are used to track the dispensing of 
investigational anticancer agents from receipt from the NCI to 
dispensing or administration to patients. Requirements for the tracking 
of investigational agents under an Investigational New Drug Application 
are outlined in Title 21 Code of Federal Regulations (CRF) part 312. 
NCI and/or its auditors use this information to ensure compliance with 
federal regulations and NCI policies. Previously, the investigator 
registration forms and process were part of this submission. These 
forms were more appropriately submitted and approved under the CTEP 
Branch and Support Contracts Forms and Surveys in July 2018 (OMB No. 
0925-0753; Expiration Date 7/31/2021). Thus, the investigator 
registration forms are no longer included in this request.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden are 3,033 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
             Category of respondent                  Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
Individuals (DARF)..............................           2,133              16            4/60           2,275

[[Page 53886]]

 
Individuals (DARF-Oral).........................             711              16            4/60             758
                                                 ---------------------------------------------------------------
    Total.......................................           2,844          45,504  ..............           3,033
----------------------------------------------------------------------------------------------------------------


Patricia M. Busche,
Project Clearance Liaison, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 2018-23313 Filed 10-24-18; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices 53885 individuals associated with the grant ACTION: Notice. Proposed Collection Title: applications, the disclosure of which Investigational Agent Accountability would constitute a clearly unwarranted SUMMARY: In compliance with the Record Forms in the Conduct of invasion of personal privacy. requirement of the Paperwork Investigational Trials for the Treatment Reduction Act of 1995 to provide Name of Committee: National Institute of of Cancer, 0925–0613, Expiration Date opportunity for public comment on Neurological Disorders and Stroke Special 3/31/2019, Revision, National Cancer Emphasis Panel; NINDS Diversity Training proposed data collection projects, the Institute (NCI), National Institutes of Grant Application Review. National Cancer Institute (NCI) will publish periodic summaries of proposed Health (NIH). Date: November 16, 2018. Time: 12:00 p.m. to 6:00 p.m. projects to be submitted to the Office of Need and Use of Information Agenda: To review and evaluate grant Management and Budget (OMB) for Collection: The U.S. Food and Drug applications. review and approval. Administration (FDA) holds the Place: National Institutes of Health, 6001 Executive Boulevard, Rockville, MD 20852 DATES: Comments regarding this National Cancer Institute (NCI), Division (Telephone Conference Call). information collection are best assured of Cancer Treatment and Diagnosis/ Contact Person: William C. Benzing, Ph.D., of having their full effect if received Cancer Therapy Evaluation Program Scientific Review Officer, Scientific Review within 60 days of the date of this (NCI/DCTD/CTEP) and the Division of Branch, NINDS/NIH/DHHS, Neuroscience publication. Cancer Prevention (DCP) responsible, as Center, 6001 Executive Blvd., Suite 3204, a sponsor of investigational drug trials, MSC 9529, Bethesda, MD 20892–9529, (301) FOR FURTHER INFORMATION CONTACT: To 496–0660, benzingw@mail.nih.gov. obtain a copy of the data collection to assure the FDA that systems for Name of Committee: National Institute of plans and instruments, submit accountability are being maintained by Neurological Disorders and Stroke Special comments in writing, or request more investigators in its clinical trials Emphasis Panel; Blueprint Neurotherapeutics information on the proposed project, program. Data obtained from the Review Meeting. contact: Charles Hall, Chief, Investigational Agent Accountability Date: November 28, 2018. Pharmaceutical Management Branch, Record Forms (aka. Drug Accountability Time: 8:00 a.m. to 6:00 p.m. Record Forms—DARF) are used to track Cancer Therapy Evaluation Program, Agenda: To review and evaluate grant applications. Division of Cancer Diagnosis and the dispensing of investigational Place: Georgetown Suites, 1111 30th Street Treatment, National Cancer Institute, anticancer agents from receipt from the NW, Washington, DC 20007. 9609 Medical Center Drive, Bethesda, NCI to dispensing or administration to Contact Person: Joel A. Saydoff, Ph.D., Maryland, 20892 or call non-toll-free patients. Requirements for the tracking Scientific Review Officer, Scientific Review number (240) 276–6575 or Email your of investigational agents under an Branch, NINDS/NIH/DHHS, Neuroscience request, including your address to: Center, 6001 Executive Blvd., Suite 3205, Investigational New Drug Application HallCh@mail.nih.gov. Formal requests are outlined in Title 21 Code of Federal MSC 9529, Bethesda, MD 20892–9529, (301) 496–9223, joel.saydoff@nih.gov. for additional plans and instruments Regulations (CRF) part 312. NCI and/or must be requested in writing. its auditors use this information to (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research SUPPLEMENTARY INFORMATION: Section ensure compliance with federal Related to Neurological Disorders; 93.854, 3506(c)(2)(A) of the Paperwork regulations and NCI policies. Biological Basis Research in the Reduction Act of 1995 requires: Written Previously, the investigator registration Neurosciences, National Institutes of Health, comments and/or suggestions from the HHS) forms and process were part of this public and affected agencies are invited submission. These forms were more Dated: October 18, 2018. to address one or more of the following appropriately submitted and approved Sylvia L. Neal, points: (1) Whether the proposed under the CTEP Branch and Support Program Analyst, Office of Federal Advisory collection of information is necessary Contracts Forms and Surveys in July Committee Policy. for the proper performance of the 2018 (OMB No. 0925–0753; Expiration [FR Doc. 2018–23264 Filed 10–24–18; 8:45 am] function of the agency, including whether the information will have Date 7/31/2021). Thus, the investigator BILLING CODE 4140–01–P practical utility; (2) The accuracy of the registration forms are no longer agency’s estimate of the burden of the included in this request. DEPARTMENT OF HEALTH AND proposed collection of information, OMB approval is requested for 3 HUMAN SERVICES including the validity of the years. There are no costs to respondents methodology and assumptions used; (3) other than their time. The total National Institutes of Health Ways to enhance the quality, utility, and estimated annualized burden are 3,033 clarity of the information to be hours. Proposed Collection; 60-Day Comment collected; and (4) Ways to minimizes Request; Investigational Agent the burden of the collection of Accountability Record Forms in the information on those who are to Conduct of Investigational Trials for respond, including the use of the Treatment of Cancer (National appropriate automated, electronic, Cancer Institute) mechanical, or other technological AGENCY: National Institutes of Health, collection techniques or other forms of HHS. information technology. daltland on DSKBBV9HB2PROD with NOTICES ESTIMATED ANNUALIZED BURDEN HOURS Number of Average time Number of Total annual Category of respondent responses per per response respondents burden hours respondent (in hours) Individuals (DARF) ........................................................................................... 2,133 16 4/60 2,275 VerDate Sep<11>2014 18:10 Oct 24, 2018 Jkt 247001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\25OCN1.SGM 25OCN1

53886 Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of Average time Number of Total annual Category of respondent responses per per response respondents burden hours respondent (in hours) Individuals (DARF-Oral) ................................................................................... 711 16 4/60 758 Total .......................................................................................................... 2,844 45,504 ........................ 3,033 Patricia M. Busche, This invention relates to a reverse • Vaccine research Project Clearance Liaison, National Cancer genetics system and cDNA-derived virus Institute, National Institutes of Health. Competitive Advantages for a contemporary wild-type clinical [FR Doc. 2018–23313 Filed 10–24–18; 8:45 am] isolate of RSV of antigenic subgroup A, • Ease of manufacture BILLING CODE 4140–01–P termed RSV strain A/Maryland/001/11, • Clinical trial material that was isolated in 2011 from an adult • Low-cost vaccines with respiratory illness. The genomic • Intranasal administration/needle- DEPARTMENT OF HEALTH AND sequence was determined. A reverse free delivery HUMAN SERVICES genetics system was created encoding a Development Stage recombinant, replication competent National Institutes of Health • In vivo data assessment (human) RSV that contains a codon-optimized G Inventors: Ursula Buchholz (NIAID), Government-Owned Inventions; ORF, which was done to stabilize the Peter Collins (NIAID). Availability for Licensing cDNA for replication in bacteria. Intellectual Property: HHS Reference Because this virus was generated by No. E–235–2018–0. AGENCY: National Institutes of Health, reverse genetics, it is a ‘‘clean’’ virus Licensing Contact: Peter Soukas, J.D., HHS. with a well-defined passage history. 301–594–8730; peter.soukas@nih.gov. ACTION: Notice. Clinical study material of this challenge Collaborative Research Opportunity: virus has been manufactured and is The National Institute of Allergy and SUMMARY: The invention listed below is available for use as an U.S. Food and owned by an agency of the U.S. Infectious Diseases is seeking statements Drug Administration (FDA) regulated of capability or interest from parties Government and is available for Investigational New Drug (IND) in licensing to achieve expeditious interested in collaborative research to clinical studies in adult volunteers further develop, evaluate or commercialization of results of within and outside of the United States. federally-funded research and commercialize for development of a Preliminary clinical data confirmed that vaccine for respiratory or other development. Foreign patent this virus efficiently infects and applications are filed on selected infections. For collaboration replicates in 95% of study participants opportunities, please contact Peter inventions to extend market coverage pre-selected for pre-existing RSV for companies and may also be available Soukas, J.D., 301–594–8730; antibody titers in the bottom 50% of the peter.soukas@nih.gov. for licensing. range. The challenge virus causes mild FOR FURTHER INFORMATION CONTACT: upper respiratory illness in the majority Dated: October 12, 2018. Peter Soukas, J.D., 301–594–8730; of infected participants, typical for RSV Suzanne M. Frisbie, peter.soukas@nih.gov. Licensing illness in otherwise healthy adults. This Deputy Director, Technology Transfer and information and copies of the patent provides a suitable challenge system for Intellectual Property Office, National Institute applications listed below may be evaluating antivirals, as well as vaccines of Allergy and Infectious Diseases. obtained by communicating with the for older children and adults. This also [FR Doc. 2018–23311 Filed 10–24–18; 8:45 am] indicated licensing contact at the could be used for developing live- BILLING CODE 4140–01–P Technology Transfer and Intellectual attenuated RSV vaccine candidates Property Office, National Institute of based on this contemporary strain, using Allergy and Infectious Diseases, 5601 the stabilized point mutations, DEPARTMENT OF HEALTH AND Fishers Lane, Rockville, MD 20852; tel. stabilized codon-deletions, and gene- HUMAN SERVICES 301–496–2644. A signed Confidential deletions that were previously used in Disclosure Agreement will be required National Institutes of Health RSV strain A2. to receive copies of unpublished patent This invention relates to a reverse applications. Center for Scientific Review; Notice of genetics system and the encoded RSV Closed Meetings SUPPLEMENTARY INFORMATION: vaccine challenge strain that infects and Technology description follows. causes disease in RSV-experienced Pursuant to section 10(d) of the Recombinant Respiratory Syncytial adults and is available for antiviral and Federal Advisory Committee Act, as Virus Challenge Strain vaccine research. amended, notice is hereby given of the This technology is available for following meetings. Description of Technology licensing for commercial development The meetings will be closed to the RSV is the most important viral agent in accordance with 35 U.S.C. 209 and 37 public in accordance with the daltland on DSKBBV9HB2PROD with NOTICES of severe respiratory tract disease CFR part 404, as well as for further provisions set forth in sections worldwide, especially in infants and development and evaluation under a 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., young children, and it also causes research collaboration. as amended. The grant applications and severe disease in the elderly and in the discussions could disclose immunocompromised individuals. Potential Commercial Applications confidential trade secrets or commercial There are no licensed vaccines or • Vaccine development property such as patentable material, antivirals suitable for routine use. • Viral diagnostics and personal information concerning VerDate Sep<11>2014 18:10 Oct 24, 2018 Jkt 247001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\25OCN1.SGM 25OCN1


Document Created: 2018-10-25 01:45:12
Document Modified: 2018-10-25 01:45:12
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
ContactTo obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Charles Hall, Chief, Pharmaceutical Management Branch, Cancer Therapy Evaluation Program, Division of Cancer Diagnosis and Treatment, National Cancer Institute, 9609 Medical Center Drive, Bethesda, Maryland, 20892 or call non-toll-free number (240) 276-6575 or Email
FR Citation83 FR 53885 
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