Agency Information Collection Activities; Proposed Collection; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests, 51455-51456 [2016-18463]
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Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices
51455
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM APRIL 1,
2016, THROUGH JUNE 30, 2016—Continued
PMA No., Docket No.
Applicant
Trade name
P150033, FDA–2016–M–1125 ................
Medtronic, Inc ..........................................
P140003/S005, FDA–2016–M–1165 .......
P150041, FDA–2016–M–1167 ................
P150016, FDA–2016–M–1166 ................
P130001, FDA–2016–M–1168 ................
P150012, FDA–2016–M–1222 ................
Abiomed, Inc ...........................................
Abbott Molecular, Inc ..............................
Neomend, Inc ..........................................
Epigenomics AG ......................................
Boston Scientific Corporation ..................
P130029/S002, FDA–2016–M–1223 .......
P160002, FDA–2016–M–1400 ................
P070014/S037, FDA–2016–M–1455 .......
P110033/S018, FDA–2016–M–1401 .......
P150047, FDA–2016–M–1459 ................
P150024, FDA–2016–M–1754 ................
P150029, FDA–2016–M–1755 ................
Bard Peripheral Vascular, Inc .................
Ventana Medical Systems, Inc ................
Bard Peripheral Vascular, Inc .................
Allergan ...................................................
Roche Molecular Systems, Inc ...............
Aspire Bariatrics, Inc ...............................
Medtronic Minimed, Inc ...........................
Medtronic MicraTM Transcatheter Pacemaker System.
Impella Left Ventricular Support System
Vysis CLL FISH Probe Kit .......................
TRIDYNETM Vascular Sealant ................
Epi proColon ............................................
ImageReady MR Conditional Pacing
System and Ingevity Pace/Sense Lead.
Fluency® Plus Endovascular Stent Graft
VENTANA PD–L1(SP142) Assay ...........
Bard® LifeStent Vascular Stent System
´
JUVEDERM VOLBELLA® XC .................
cobas® EGFR Mutation Test v2 .............
AspireAssist® ...........................................
iPro2 Continuous Glucose Monitoring
System With Enlite Sensor.
II. Electronic Access
Submit either electronic or
written comments on the collection of
information by October 3, 2016.
ADDRESSES: You may submit comments
as follows:
DATES:
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/MedicalDevices/
ProductsandMedicalProcedures/
DeviceApprovalsandClearances/
PMAApprovals/default.htm.
Electronic Submissions
Dated: August 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18508 Filed 8–3–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2066]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Certification of
Identity for Freedom of Information Act
and Privacy Act Requests
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
‘‘Certification of Identity for Freedom of
Information Act and Privacy Act
Requests.’’
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
PO 00000
Frm 00026
Fmt 4703
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Approval date
4/6/2016
4/7/2016
4/11/2016
4/11/2016
4/12/2016
4/25/2016
4/26/2016
5/18/2016
5/31/2016
5/31/2016
6/1/2016
6/14/2016
6/17/2016
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–N–2066 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Certification of Identity for Freedom of
Information Act and Privacy Act
Requests.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
E:\FR\FM\04AUN1.SGM
04AUN1
51456
Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20851,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’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 minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Certification of Identity for Freedom of
Information Act and Privacy Act
Requests OMB Control Number 0910—
NEW
In compliance with 44 U.S.C. 3507,
FDA will submit to the Office of
Management and Budget a request to
review and approve a new collection of
information: Certification of Identity for
Freedom of Information Act and Privacy
Act Requests. This new form provides
the FDA with data necessary to identify
an individual requesting a particular
record under the Freedom of
Information Act (FOIA) and the Privacy
Act. The form is available at the
following FDA FOIA page at: https://
www.fda.gov/RegulatoryInformation/
FOI/default.htm, although if an
individual requests one, we will send it
by mail or email. The FOIA grants the
public a right to access Federal records
not normally prepared for public
distribution. The Privacy Act grants a
right of access to members of the public
who seek access to one’s own records
that are maintained in an Agency’s
system of records (i.e. the records are
retrieved by that individual’s name or
other personal identifier). The statutes
overlap, and individuals who request
their own records are processed under
both statutes. The Agency may need to
confirm that the individual making the
FOIA or Privacy Act request is indeed
the same person named in the Agency
records.
Members of the public who wish to
access particular records will be asked
for certain information: Name,
citizenship status, social security
number, address, date of birth, place of
birth, signature, and date of signature.
FDA estimates the burden of this
collection of information as follows:
As stated in table 1, the estimates are
based on the following: The number of
FOIA and Privacy Act requests received
by FDA each year that require a
certification of identity in order for FDA
to process the request. Of the 10,000
requests received per year, only a small
number require a certification of
identity. In some cases, the requesters
provide their own certification of
identity. Therefore, we have estimated
the number of affected individuals at 60
per year.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA Form No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
3975 ............................................................................
60
1
60
.17 (10 minutes) .....
10
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18463 Filed 8–3–16; 8:45 am]
sradovich on DSK3GMQ082PROD with NOTICES
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Announcement of Requirements and
Registration for the ‘‘MRC Serves’’
Video Challenge
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The Medical Reserve Corps
(MRC) Program housed under the Office
of the Assistant Secretary for
SUMMARY:
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18:12 Aug 03, 2016
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PO 00000
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Preparedness and Response (ASPR)
within the U.S. Department of Health
and Human Services (HHS), announces
the launch of the ‘‘MRC Serves’’ Video
Challenge. The MRC is a national
network of volunteers, organized locally
to improve the health and safety of their
communities. MRC volunteers have
medical, public health, other
backgrounds and have responded to
natural disasters, public health and
other emergencies, while also
supporting community health activities.
The MRC Program is looking for
E:\FR\FM\04AUN1.SGM
04AUN1
]]>Agencies
[Federal Register Volume 81, Number 150 (Thursday, August 4, 2016)]
[Notices]
[Pages 51455-51456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18463]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2066]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Certification of Identity for Freedom of Information
Act and Privacy Act Requests
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on ``Certification of Identity for Freedom of
Information Act and Privacy Act Requests.''
DATES: Submit either electronic or written comments on the collection
of information by October 3, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-N-2066 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Certification of Identity for
Freedom of Information Act and Privacy Act Requests.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover
[[Page 51456]]
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20851, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA'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 minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Certification of Identity for Freedom of Information Act and Privacy
Act Requests OMB Control Number 0910--NEW
In compliance with 44 U.S.C. 3507, FDA will submit to the Office of
Management and Budget a request to review and approve a new collection
of information: Certification of Identity for Freedom of Information
Act and Privacy Act Requests. This new form provides the FDA with data
necessary to identify an individual requesting a particular record
under the Freedom of Information Act (FOIA) and the Privacy Act. The
form is available at the following FDA FOIA page at: https://www.fda.gov/RegulatoryInformation/FOI/default.htm, although if an
individual requests one, we will send it by mail or email. The FOIA
grants the public a right to access Federal records not normally
prepared for public distribution. The Privacy Act grants a right of
access to members of the public who seek access to one's own records
that are maintained in an Agency's system of records (i.e. the records
are retrieved by that individual's name or other personal identifier).
The statutes overlap, and individuals who request their own records are
processed under both statutes. The Agency may need to confirm that the
individual making the FOIA or Privacy Act request is indeed the same
person named in the Agency records.
Members of the public who wish to access particular records will be
asked for certain information: Name, citizenship status, social
security number, address, date of birth, place of birth, signature, and
date of signature.
FDA estimates the burden of this collection of information as
follows:
As stated in table 1, the estimates are based on the following: The
number of FOIA and Privacy Act requests received by FDA each year that
require a certification of identity in order for FDA to process the
request. Of the 10,000 requests received per year, only a small number
require a certification of identity. In some cases, the requesters
provide their own certification of identity. Therefore, we have
estimated the number of affected individuals at 60 per year.
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FDA Form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
3975....................................... 60 1 60 .17 (10 minutes)....................... 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18463 Filed 8-3-16; 8:45 am]
BILLING CODE 4164-01-P
