Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests, 19049-19050 [2017-08303]
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Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices
noted, these activities will be conducted
throughout the United States.
Each notice is available for inspection
at the Federal Reserve Bank indicated.
The notice also will be available for
inspection at the offices of the Board of
Governors. Interested persons may
express their views in writing on the
question whether the proposal complies
with the standards of section 10(c)(4)(B)
of the HOLA 12 U.S.C. 1467a(c)(4)(B).
Unless otherwise noted, comments
regarding the notices must be received
at the Reserve Bank indicated or the
offices of the Board of Governors not
later than May 10, 2017.
A. Federal Reserve Bank of Dallas
(Robert L. Triplett III, Senior Vice
President) 2200 North Pearl Street,
Dallas, Texas 75201–2272:
1. The SLHC Trust and The Mark and
Pamela Okada Family Trust, and
NexBank Capital, Inc., all of Dallas,
Texas; to continue to engage in the
activities of (i) the acquisition of
improved real estate to be held for rental
and (ii) the maintenance and
management of improved real estate
pursuant to sections 238.53(b)(6) and
(b)(8) of Regulation LL.
Board of Governors of the Federal Reserve
System, April 19, 2017.
Margaret M. Shanks,
Deputy Secretary of the Board.
[FR Doc. 2017–08276 Filed 4–24–17; 8:45 am]
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 25,
2017.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Certification of Identity for
Freedom of Information Act and Privacy
Act Requests.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Cappezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794.
ADDRESSES:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2066]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Certification of
Identity for Freedom of Information Act
and Privacy Act Requests
AGENCY:
ACTION:
Food and Drug Administration,
HHS.
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 OMB 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
19049
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.
In the Federal Register of August 4,
2016 (81 FR 51455), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
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
asabaliauskas on DSK3SPTVN1PROD with NOTICES
FDA form No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per response
Total hours
3975 ..................................................
60
1
60
0.17 (10 minutes) .............................
10
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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17:42 Apr 24, 2017
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25APN1
19050
Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices
Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
Guidance for Industry on Citizen
Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the
Federal Food, Drug, and Cosmetic
Act—OMB Control Number 0910–
0679—Extension
[FR Doc. 2017–08303 Filed 4–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0008]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Citizen Petitions
and Petitions for Stay of Action
Subject to Section 505(q) of the
Federal Food, Drug, and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
Fax written comments on the
collection of information by May 25,
2017.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0679. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:42 Apr 24, 2017
Jkt 241001
FDA’s guidance for industry entitled
‘‘Citizen Petitions and Petitions for Stay
of Action Subject to Section 505(q) of
the Federal Food, Drug, and Cosmetic
Act’’ provides information regarding
FDA’s current thinking on interpreting
section 914 of Title IX of the Food and
Drug Administration Amendments Act
(FDAAA) (Pub. L. 110–85). Section 914
of FDAAA added new section 505(q) to
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 355(q))
and governs certain citizen petitions
and petitions for stay of Agency action
that request that FDA take any form of
action related to a pending application
submitted under section 505(b)(2) or
505(j) of the FD&C Act. The guidance
describes FDA’s interpretation of
section 505(q) of the FD&C Act
regarding how the Agency will
determine if: (1) The provisions of
section 505(q) addressing the treatment
of citizen petitions and petitions for stay
of Agency action (collectively, petitions)
apply to a particular petition and (2) a
petition would delay approval of a
pending abbreviated new drug
application (ANDA) or a 505(b)(2)
application. The guidance also describes
how FDA will interpret the provisions
of section 505(q) requiring that: (1) A
petition includes a certification and (2)
supplemental information or comments
to a petition include a verification.
Finally, the guidance addresses the
relationship between the review of
petitions and pending ANDAs and
505(b)(2) applications for which the
Agency has not yet made a decision on
approvability.
The Food and Drug Administration
Safety and Innovation Act (FDASIA)
was signed into law on July 9, 2012
(Pub. L. 112–144). Section 1135 of
FDASIA amended section 505(q) of the
FD&C Act in two ways. First, it
shortened FDA’s deadline from 180
days to 150 days for responding to
petitions subject to section 505(q) of the
FD&C Act. Second, it expanded the
scope of section 505(q) of the FD&C Act
to include certain petitions concerning
applications submitted under section
351(k) of the Public Health Service Act
(42 U.S.C. 262), the abbreviated
pathway for the approval of biosimilar
biological products. Accordingly, we are
now including submissions pertaining
to biosimilar biological product
applications in the information
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Fmt 4703
Sfmt 4703
collection burden estimates in this
document.
Section 505(q)(1)(H) of the FD&C Act
requires that citizen petitions and
petitions for stay of Agency action that
are subject to section 505(q) include a
certification to be considered for review
by FDA. Section 505(q)(1)(I) of the
FD&C Act requires that supplemental
information or comments to such citizen
petitions and petitions for stay of
Agency action include a verification to
be accepted for review by FDA. The
guidance sets forth the criteria the
Agency will use in determining if the
provisions of section 505(q) of the FD&C
Act apply to a particular citizen petition
or petition for stay of Agency action.
The guidance states that one of the
criteria for a citizen petition or petition
for stay of Agency action to be subject
to section 505(q) of the FD&C Act is that
a related ANDA or 505(b)(2) application
is pending at the time the citizen
petition or petition for stay is submitted.
Because petitioners or commenters may
not be aware of the existence of a
pending ANDA or 505(b)(2) application,
the guidance recommends that all
petitioners challenging the
approvability of a possible ANDA or
505(b)(2) application include the
certification required in section
505(q)(1)(H) of the FD&C Act and that
petitioners and commenters submitting
supplements or comments, respectively,
to a citizen petition or petition for stay
of action challenging the approvability
of a possible ANDA or 505(b)(2)
application include the verification
required in section 505(q)(1)(I) of the
FD&C Act. The guidance also
recommends that if a petitioner submits
a citizen petition or petition for stay of
Agency action that is missing the
required certification but is otherwise
within the scope of section 505(q) of the
FD&C Act and the petitioner would like
FDA to review the citizen petition or
petition for stay of Agency action, the
petitioner should submit a letter
withdrawing the deficient petition and
submit a new petition that contains the
required certification.
FDA currently has OMB approval for
the collection of information entitled
‘‘General Administrative Procedures:
Citizen Petitions; Petition for
Reconsideration or Stay of Action;
Advisory Opinions’’ (OMB control
number 0910–0191). This collection of
information includes, among other
things: (1) The format and procedures
by which an interested person may
submit to FDA, in accordance with
§ 10.20 (21 CFR 10.20), a citizen petition
requesting the Commissioner of Food
and Drugs (Commissioner) to issue,
amend, or revoke a regulation or order,
E:\FR\FM\25APN1.SGM
25APN1
]]>Agencies
[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19049-19050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08303]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2066]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by May 25,
2017.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-NEW and
title ``Certification of Identity for Freedom of Information Act and
Privacy Act Requests.'' Also include the FDA docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Cappezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 OMB 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.
In the Federal Register of August 4, 2016 (81 FR 51455), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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 0.17 (10 minutes)................. 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 19050]]
Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08303 Filed 4-24-17; 8:45 am]
BILLING CODE 4164-01-P
