National Institute of Mental Health; Notice of Closed Meetings, 36552-36553 [2016-13310]
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Federal Register / Vol. 81, No. 109 / Tuesday, June 7, 2016 / Notices
holds the biological product license, for
other than human blood and blood
components, and who had control over
a distributed product when the
deviation occurred, to report to the
Center for Biologics Evaluation and
Research (CBER) or to the Center for
Drugs Evaluation and Research (CDER)
as soon as possible but at a date not to
exceed 45 calendar days after acquiring
information reasonably suggesting that a
reportable event has occurred. Section
606.171, in brief, requires licensed
manufacturers of human blood and
blood components, including Source
Plasma, unlicensed registered blood
establishments, and transfusion
services, who had control over a
distributed product when the deviation
occurred, to report to CBER as soon as
possible but at a date not to exceed 45
calendar days after acquiring
information reasonably suggesting that a
reportable event has occurred.
Similarly, § 1271.350(b), in brief,
requires HCT/P establishments that
manufacture non-reproductive HCT/Ps
described in § 1271.10 to investigate and
report to CBER all HCT/P deviations
relating to a distributed HCT/P that
relates to the core CGTP requirements,
if the deviation occurred in the
establishment’s facility or in a facility
that performed a manufacturing step for
the establishment under contract,
agreement, or other arrangement. Form
FDA 3486 is used to submit BPD reports
and HCT/P deviation reports.
Respondents to this collection of
information are: (1) Licensed
manufacturers of biological products
other than human blood and blood
components, (2) licensed manufacturers
of blood and blood components
including Source Plasma, (3) unlicensed
registered blood establishments, (4)
transfusion services, and (5)
establishments that manufacture nonreproductive HCT/Ps regulated solely
under section 361 of the PHS Act as
described in § 1271.10. The number of
respondents and total annual responses
are based on the BPD reports and HCT/
P deviation reports FDA received in
fiscal year 2015. The number of licensed
manufacturers and total annual
responses under § 600.14 include the
estimates for BPD reports submitted to
both CBER and CDER. Based on the
information from industry, the
estimated average time to complete a
deviation report is 2 hours, which
includes a minimal one-time burden to
create a user account for those reports
submitted electronically. The
availability of the standardized report
form, Form FDA 3486, and the ability to
submit this report electronically to
CBER (CDER does not currently accept
electronic filings) further streamlines
the report submission process.
CBER has developed a Web-based
addendum to Form FDA 3486 (Form
FDA 3486A) to provide additional
information when a BPD report has been
reviewed by FDA and evaluated as a
possible recall. The additional
information requested includes
information not contained in the Form
FDA 3486 such as: (1) Distribution
pattern; (2) method of consignee
notification; (3) consignee(s) of products
for further manufacture; (4) additional
product information; (5) updated
product disposition; and (6) industry
recall contacts. This information is
requested by CBER through email
notification to the submitter of the BPD
report. This information is used by
CBER for recall classification purposes.
At this time, Form FDA 3486A is being
used only for those BPD reports
submitted under § 606.171. CBER
estimates that 5 percent of the total BPD
reports submitted to CBER under
§ 606.171 would need additional
information submitted in Form FDA
3486A. CBER further estimates that it
would take between 10 to 20 minutes to
complete Form FDA 3486A. For
calculation purposes, CBER is using 15
minutes.
Activities such as investigating,
changing standard operating procedures
or processes, and followup are currently
required under parts 211 (approved
under OMB control number 0910–0139),
part 606 (approved under OMB control
number 0910–0116), part 820 (approved
under OMB control number 0910–0073),
and part 1271 (approved under OMB
control number 0910–0543) and,
therefore, are not included in the
burden calculation for the separate
requirement of submitting a deviation
report to FDA.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA
form No.
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden
per response
Total
hours
600.14 ..........................................
606.171 ........................................
1271.350(b) ..................................
Web-based Addendum ................
3486
3486
3486
2 3486A
102
1,738
97
87
5.99
26.34
2.64
26.31
611
45,774
256
2,289
2 ................................
2 ................................
2 ................................
.25 (15 minutes) ........
1,222
91,548
512
572
Total ......................................
........................
........................
........................
........................
....................................
93,854
1 There
2 Five
are no capital costs or operating and maintenance costs associated with this collection of information.
percent of the number of respondents (1,738 × 0.05 = 87) and total annual responses to CBER (45,774 × 0.05 = 2,289).
Dated: May 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
[FR Doc. 2016–13366 Filed 6–6–16; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meetings
BILLING CODE 4164–01–P
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings 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.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel Pilot
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36553
Federal Register / Vol. 81, No. 109 / Tuesday, June 7, 2016 / Notices
Effectiveness Trials for Treatment, Preventive
and Services Interventions (R34)
Date: June 24, 2016.
Time: 11:30 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Karen Gavin-Evans, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Boulevard, Room 6153, MSC
9606, Bethesda, MD 20892, 301–451–2356,
gavinevanskm@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel,
Fellowship and Dissertation Grants Review
Meeting.
Date: June 30, 2016.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Marcy Ellen Burstein,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH Neuroscience Center,
6001 Executive Blvd., Room 6143, MSC 9606,
Bethesda, MD 20892–9606, 301–443–9699,
bursteinme@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel,
Mental Health Services Conflicts
(Teleconference).
Date: June 30, 2016.
Time: 12:30 p.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Karen Gavin-Evans, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH Neuroscience Center,
6001 Executive Boulevard, Room 6153, MSC
9606, Bethesda, MD 20892, 301–451–2356,
gavinevanskm@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: June 1, 2016.
Carolyn A. Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
To
obtain a copy of the data collection
plans and instruments, or request more
information on the proposed project,
contact*: Michele M. Doody, Radiation
Epidemiology Branch, National Cancer
Institute, 9609 Medical Center Drive,
Room 7E566, Rockville, MD 20850, or
call non-toll-free number 301–414–
0308. Or Email your request, including
your address to: doodym@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: U.S. Nuclear
Medicine Technologists Study, 0925–
0656, Expiration Date 04/30/2015—
REINSTATEMENT WITH CHANGE,
National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: We propose to collect from
U.S. nuclear medicine technologists
(USNMT) certified after 1980 historical
information about nuclear medicine
procedures performed, radioisotopes
used, related work and safety practices,
and places of employment. The primary
objectives of the current feasibility effort
are: (a) To identify a cohort of nuclear
medicine technologists certified after
1980 by the American Registry of
Radiologic Technologists (ARRT) and/or
the Nuclear Medicine Technologist
Certification Board (NMTCB); and (b) to
characterize individual organ-specific
occupational radiation doses from
radioisotope procedures. More recently
certified technologists, who specialized
in nuclear medicine, are expected to
have greater exposures to radioisotopes
than the general radiologic technologists
in the U.S. Radiologic Technologist
(USRT) cohort owing to performing
such procedures with greater frequency.
The proposed USNMT study would be
a direct follow-on to the USRT Study to
assess health risks associated with
occupational exposure to these much
higher-energy radiopharmaceuticals.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
125.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2016–13310 Filed 6–6–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-day
Comment Request, U.S. Nuclear
Medicine Technologists Study (NCI)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute, the National Institutes
of Health, has submitted to the Office of
Management and Budget (OMB) a
request for review and approval of the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on March 28, 2016 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, 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.
Direct Comments to OMB: 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: NIH Desk Officer.
Comment Due Date: 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:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Frequency of
response
Average time
per response
(hours)
Annual hour
burden
Type of respondent
Instrument
Nuclear Medicine Technologists .......
Nuclear Medicine Questionnaire ......
250
1
30/60
125
Total ...........................................
...........................................................
250
250
........................
125
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]]>Agencies
[Federal Register Volume 81, Number 109 (Tuesday, June 7, 2016)]
[Notices]
[Pages 36552-36553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13310]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the following
meetings.
The meetings will be closed to the public in accordance with the
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.
Name of Committee: National Institute of Mental Health Special
Emphasis Panel Pilot
[[Page 36553]]
Effectiveness Trials for Treatment, Preventive and Services
Interventions (R34)
Date: June 24, 2016.
Time: 11:30 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852, (Telephone Conference
Call).
Contact Person: Karen Gavin-Evans, Ph.D., Scientific Review
Officer, Division of Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center, 6001 Executive Boulevard,
Room 6153, MSC 9606, Bethesda, MD 20892, 301-451-2356,
gavinevanskm@mail.nih.gov.
Name of Committee: National Institute of Mental Health Special
Emphasis Panel, Fellowship and Dissertation Grants Review Meeting.
Date: June 30, 2016.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852, (Telephone Conference
Call).
Contact Person: Marcy Ellen Burstein, Ph.D., Scientific Review
Officer, Division of Extramural Activities, National Institute of
Mental Health, NIH Neuroscience Center, 6001 Executive Blvd., Room
6143, MSC 9606, Bethesda, MD 20892-9606, 301-443-9699,
bursteinme@mail.nih.gov.
Name of Committee: National Institute of Mental Health Special
Emphasis Panel, Mental Health Services Conflicts (Teleconference).
Date: June 30, 2016.
Time: 12:30 p.m. to 1:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852, (Telephone Conference
Call).
Contact Person: Karen Gavin-Evans, Ph.D., Scientific Review
Officer, Division of Extramural Activities, National Institute of
Mental Health, NIH Neuroscience Center, 6001 Executive Boulevard,
Room 6153, MSC 9606, Bethesda, MD 20892, 301-451-2356,
gavinevanskm@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program No. 93.242, Mental
Health Research Grants, National Institutes of Health, HHS)
Dated: June 1, 2016.
Carolyn A. Baum,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-13310 Filed 6-6-16; 8:45 am]
BILLING CODE 4140-01-P
