Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request, 8208-8209 [2016-03249]
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8208
Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices
C. Gastroenterology and Urology
Devices Panel
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational
gastroenterology, urology and
nephrology devices and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
D. General and Plastic Surgery Devices
Panel
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational general
and plastic surgery devices and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
E. Hematology and Pathology Devices
Panel
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational in vitro
devices for use in clinical laboratory
medicine including pathology,
hematology, histopathology,
cytotechnology and molecular biology
and makes appropriate
recommendations to the Commissioner
of Food and Drugs.
F. Medical Devices Dispute Resolution
Provides advice to the Center Director
on complex or contested scientific
issues between the FDA and medical
device sponsors, applicants, or
manufacturers relating to specific
products, marketing applications,
regulatory decisions and actions by
FDA, and Agency guidance and
policies. The Panel makes
recommendations on issues that are
lacking resolution, are highly complex
in nature, or result from challenges to
Agency decisions or actions.
G. Microbiology Devices Panel
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational in vitro
devices for use in clinical laboratory
medicine including microbiology,
virology, and infectious disease and
makes appropriate recommendations to
the Commissioner of Food and Drugs.
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H. Molecular and Clinical Genetics
Devices Panel
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational in vitro
devices for use in clinical laboratory
medicine including clinical and
molecular genetics and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
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I. Neurological Devices Panel
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational devices
for use in the neurological system and
makes appropriate recommendations to
the Commissioner of Food and Drugs.
J. Orthopaedic and Rehabilitation
Devices Panel
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational
orthopedic and rehabilitation devices
and makes appropriate
recommendations to the Commissioner
of Food and Drugs.
K. Radiological Devices Panel
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational
diagnostics or therapeutic radiological
and nuclear medicine devices and
makes appropriate recommendations to
the Commissioner of Food and Drugs.
II. Qualifications
Persons nominated for the device
panels should be full-time employees of
firms that manufacture products that
would come before the panel, or
consulting firms that represent
manufacturers, or have similar
appropriate ties to industry.
III. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for a particular device panel.
The interested organizations are not
bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner will select the
nonvoting member to represent industry
interests.
IV. Application Procedure
Individuals may self nominate and/or
an organization may nominate one or
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more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the Committee of
interest may be submitted to the FDA
Advisory Committee Membership
Nomination Portal (see ADDRESSES)
within 30 days of publication of this
document (see DATES). FDA will forward
all nominations to the organizations
expressing interest in participating in
the selection process for the particular
device panel. (Persons who nominate
themselves as nonvoting industry
representatives will not participate in
the selection process).
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: February 11, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–03283 Filed 2–17–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier OS–4040–0005 60D]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
AGENCY:
Electronic Government Office,
HHS.
ACTION:
Notice.
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Electronic
Government Office (EGOV), Department
of Health and Human Services, has
submitted an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB) for review and approval. The ICR
is for a 3-year extension for OMB
Control Number 4040–0005. The ICR
will expire on July 31, 2016. The ICR
also requests categorizing the form as a
common form, meaning HHS will only
request approval for its own use of the
form rather than aggregating the burden
estimate across all Federal Agencies as
was done for previous actions on this
OMB control number. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be
received on or before April 18, 2016.
SUMMARY:
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8209
Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices
Submit your comments to
ed.calimag@hhs.gov or (202) 690–7569.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the OMB
control number 4040–0005. Form is
available https://www.grants.gov or upon
request.
Information Collection Request Title:
SF–424 Application for Federal
Assistance—Individual.
OMB No.: 4040–0005.
Abstract: The SF–424 Application for
Federal Assistance—Individual is a
common form used by Federal grantmaking agencies for individual
applicants without DUNS numbers to
apply for Federal financial assistance.
Need and Proposed Use of the
Information: The SF–424 Application
for Federal Assistance—The Individual
common form is used by individuals not
ADDRESSES:
HHS does not use the form; however,
HHS estimates that the SF–424
Application for Federal Assistance—
Individual’s will take 1 hour to
complete.
Once OMB approves the use of this
common form, federal agencies may
request OMB approval to use this
common form without having to publish
notices and request public comments for
60 and 30 days. Each agency must
account for the burden associated with
their use of the common form.
EGOV specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
associated with organizations to apply
for Federal financial assistance in the
form of grants. These forms are
submitted to the Federal grant-making
agencies for evaluation and review.
Likely Respondents: Organizations
and institutions seeking grants.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions, to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information, to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information, and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Form name
Average
burden per
response
(in hours)
Total
burden hours
SF–424 Application for Federal Assistance—Individual ..................................
0
1
1
0
Total ..........................................................................................................
0
........................
........................
0
Terry S. Clark,
Asst Information Collection Clearance
Officer.
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
[FR Doc. 2016–03249 Filed 2–17–16; 8:45 am]
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Special
Emphasis Panel; Multi-Site Randomized
Controlled Clinical Trial Research Center on
Alcohol’s Health Effects (U10).
Date: March 29, 2016.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health—
NIAAA, 5635 Fishers Lane, Conference Room
2098, Rockville, MD 20892 (Telephone
Conference Call).
Contact Person: Ranga Srinivas, Ph.D.,
Chief, Extramural Project Review Branch,
National Institute on Alcohol Abuse and
Alcoholism, National Institutes of Health,
5365 Fishers Lane, Room 2085, Rockville,
MD 20852, (301) 451–2067, srinivar@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
BILLING CODE 4150–57–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
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 meeting.
The meeting 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
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and Research Support Awards, National
Institutes of Health, HHS)
Dated: February 11, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–03240 Filed 2–17–16; 8:45 am]
BILLING CODE 4140–01–P
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,
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Agencies
[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Notices]
[Pages 8208-8209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03249]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
[Document Identifier OS-4040-0005 60D]
Agency Information Collection Activities; Submission to OMB for
Review and Approval; Public Comment Request
AGENCY: Electronic Government Office, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Electronic Government Office (EGOV),
Department of Health and Human Services, has submitted an Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB) for review and approval. The ICR is for a 3-year
extension for OMB Control Number 4040-0005. The ICR will expire on July
31, 2016. The ICR also requests categorizing the form as a common form,
meaning HHS will only request approval for its own use of the form
rather than aggregating the burden estimate across all Federal Agencies
as was done for previous actions on this OMB control number. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public on this ICR
during the review and approval period.
DATES: Comments on the ICR must be received on or before April 18,
2016.
[[Page 8209]]
ADDRESSES: Submit your comments to ed.calimag@hhs.gov or (202) 690-
7569.
FOR FURTHER INFORMATION CONTACT: Information Collection Clearance
staff, Information.CollectionClearance@hhs.gov or (202) 690-6162.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the OMB control number 4040-0005. Form is
available https://www.grants.gov or upon request.
Information Collection Request Title: SF-424 Application for
Federal Assistance--Individual.
OMB No.: 4040-0005.
Abstract: The SF-424 Application for Federal Assistance--Individual
is a common form used by Federal grant-making agencies for individual
applicants without DUNS numbers to apply for Federal financial
assistance.
Need and Proposed Use of the Information: The SF-424 Application
for Federal Assistance--The Individual common form is used by
individuals not associated with organizations to apply for Federal
financial assistance in the form of grants. These forms are submitted
to the Federal grant-making agencies for evaluation and review.
Likely Respondents: Organizations and institutions seeking grants.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions, to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information, to train personnel and to be able to respond to
a collection of information, to search data sources, to complete and
review the collection of information, and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
HHS does not use the form; however, HHS estimates that the SF-424
Application for Federal Assistance--Individual's will take 1 hour to
complete.
Once OMB approves the use of this common form, federal agencies may
request OMB approval to use this common form without having to publish
notices and request public comments for 60 and 30 days. Each agency
must account for the burden associated with their use of the common
form.
EGOV specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
SF-424 Application for Federal Assistance-- 0 1 1 0
Individual.....................................
---------------------------------------------------------------
Total....................................... 0 .............. .............. 0
----------------------------------------------------------------------------------------------------------------
Terry S. Clark,
Asst Information Collection Clearance Officer.
[FR Doc. 2016-03249 Filed 2-17-16; 8:45 am]
BILLING CODE 4150-57-P