30-day FRN

785

Federal Register / Vol. 84, No. 21 / Thursday, January 31, 2019 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-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.

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.
SUMMARY:

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,
OIRA_submission@omb.eop.gov 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
ADDRESSES:

instruments, 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 nontoll-free number (240) 276–6575 or
Email your request, including your
address to: HallCh@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on October 25, 2018 (83 FR
53885) and allowed 60 days for public
comment. One public comment was
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, 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: 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
respondents

Category of respondent

Average
time per
response
(in hours)

Total annual
burden hours

Individuals (DARF) ...........................................................................................
Individuals (DARF-Oral) ...................................................................................

2,133
711

16
16

4/60
4/60

2,275
758

Total ..........................................................................................................

2,844

45,504

........................

3,033

Patricia M. Busche,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2019–00447 Filed 1–30–19; 8:45 am]

National Institutes of Health

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Number of
responses
per
respondent

Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the

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provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.

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