Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 38633-38634 [2019-16889]
Download as PDF
<![CDATA[
38633
Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / Notices
that the terms and conditions of the
order are not being satisfied.
V. Order
For the reasons stated above, and
pursuant to section 1119(b) of Title XI
and 12 CFR part 1102, subpart A, the
ASC grants temporary waiver relief to
the Requester, subject to the following
specified terms and conditions:
• A temporary waiver of appraiser
credentialing requirements for
appraisals of FRTs under $500,000 for 1to-4 family residential real estate
transactions throughout the State of
North Dakota for a period of one year,
unless the federal banking agencies
issue a rule increasing appraisal
exemption threshold limits for
residential real estate transactions,13 in
which case the residential waiver will
terminate 60 days after the effective date
of that threshold increase.
• A temporary waiver of appraiser
credentialing requirements for
appraisals of FRTs under $1,000,000 for
commercial real estate transactions
throughout the State of North Dakota for
a period of one year.
• During the one-year period, the
Requester is expected to develop a plan
through continued dialogue with North
Dakota stakeholders, including the
Appraiser Board, to identify potential
solutions to address appraiser scarcity
and appraisal delay.
• At least 30 days prior to the
expiration of the one-year period, the
Requester should provide (1) a status
report to the ASC on the plan that was
developed in collaboration with
stakeholders and any implementation
progress made on that plan toward
identifying meaningful solutions to
resolve appraiser scarcity and delay
issues faced in North Dakota; and (2)
supporting data showing that appraiser
scarcity leading to significant delays
continues to exist, which may include
information to identify specific
localities affected by appraiser scarcity.
The ASC will consider the information
as presented by the Requester, and by
vote in open session, may extend the
temporary waiver for an additional oneyear period.
• The ASC at any time may terminate
a waiver order on a finding that
significant delay in the receipt of
appraisals for FRTs no longer exists, or
that the terms and conditions of the
order are not being satisfied.
*
*
*
*
*
By the Appraisal Subcommittee.
Dated: August 2, 2019.
Arthur Lindo,
Chairman.
[FR Doc. 2019–16908 Filed 8–6–19; 8:45 am]
BILLING CODE 6700–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2018–N–4131, FDA–
2018–N–0821, FDA–2013–N–0032, FDA–
2014–N–0801, FDA–2007–D–0429, FDA–
2013–N–0013, and FDA–2008–D–0530]
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
SUMMARY:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10 a.m.–12 p.m., 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
number
Title of collection
jspears on DSK3GMQ082PROD with NOTICES
FDA Adverse Event and Products Experience Reports; Electronic Submissions ..................................................
Investigation of Consumer Perceptions of Expressed Modified Risk Claims .........................................................
Food Labeling: Notification Procedures for Statements on Dietary Supplements ..................................................
Export Notification and Recordkeeping Requirements ...........................................................................................
Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by
the Dietary Supplement and Nonprescription Drug Consumer Protection Act ...................................................
Sanitary Transportation of Human and Animal Food ..............................................................................................
Guidance for Industry on Tropical Disease Priority Review Vouchers ...................................................................
13 83
FR 63110 (December 7, 2018).
VerDate Sep<11>2014
16:49 Aug 06, 2019
Jkt 247001
PO 00000
Frm 00047
Fmt 4703
Sfmt 9990
E:\FR\FM\07AUN1.SGM
07AUN1
Date approval
expires
0910–0645
0910–0873
0910–0331
0910–0482
6/30/2022
6/30/2022
7/31/2022
7/31/2022
0910–0641
0910–0773
0910–0822
7/31/2022
7/31/2022
7/31/2022
38634
Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / Notices
Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16889 Filed 8–6–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2832]
Request for Nominations From
Industry Organizations Interested in
Participating in the Selection Process
for Nonvoting Industry
Representatives and Request for
Nomination for Nonvoting Industry
Representatives on the Vaccines and
Related Biological Products Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
requesting that any industry
organizations interested in participating
in the selection of a nonvoting industry
representative to serve on the Vaccines
and Related Biological Products
Advisory Committee (VRBPAC) for the
Center for Biologics Evaluation and
Research (CBER) notify FDA in writing.
FDA is also requesting nominations for
a nonvoting industry representative(s) to
serve on the VRBPAC. A nominee may
either be self-nominated or nominated
by an organization to serve as a
nonvoting industry representative.
Nominations will be accepted for
current vacancies effective with this
notice.
SUMMARY:
Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by September 6, 2019, (see sections
I and II of this document for further
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by September 6,
2019.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nomination should be sent to Serina
Hunter-Thomas (see FOR FURTHER
INFORMATION CONTACT). All nominations
for nonvoting industry representatives
may be submitted electronically by
accessing the FDA Advisory Committee
Membership Nomination Portal: https://
jspears on DSK3GMQ082PROD with NOTICES
DATES:
VerDate Sep<11>2014
16:49 Aug 06, 2019
Jkt 247001
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm.
Information about becoming a member
of an FDA advisory committee can also
be obtained by visiting FDA’s website:
https://www.fda.gov/
AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT:
Serina Hunter-Thomas, Division of
Scientific Advisors and Consultants,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 6338, Silver Spring,
MD 20993–0002, 240–402–5771, Fax:
301–595–1307, Serina.Hunter-Thomas@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add a nonvoting
industry representative(s) to the
following advisory committee:
I. CBER Advisory Committee
Vaccines and Related Biological
Products Advisory Committee
The committee reviews and evaluates
data concerning the safety,
effectiveness, and appropriate use of
vaccines and related biological products
which are intended for use in the
prevention, treatment, or diagnosis of
human diseases, and, as required, any
other products for which FDA has
regulatory responsibility. The
committee also considers the quality
and relevance of FDA’s research
program which provides scientific
support for the regulation of these
products and makes appropriate
recommendations to the Commissioner
of Food and Drugs (Commissioner).
II. 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,
as well as 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 the
committee. The interested organizations
are not bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
the Commissioner will select the
nonvoting member to represent industry
interests.
III. Application Procedure
Individuals may self-nominate, and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent 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 committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
FDA seeks to include the views of
women, men, members of all racial and
ethnic groups, and individuals with and
without disabilities on its advisory
committees and therefore encourages
nominations of appropriately qualified
candidates from these groups.
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: July 31, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16877 Filed 8–6–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3369]
Evaluating the Clinical Pharmacology
of Oligonucleotide Therapeutics;
Establishment of a Public Docket;
Request for Information and
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for information
and comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
establishing a public docket to collect
comments on evaluating the clinical
pharmacology of oligonucleotide
therapeutics. There are many unique
clinical pharmacology considerations
concerning the development of
oligonucleotide therapeutics; however,
for the purposes of this request, the
Agency is specifically interested in
SUMMARY:
E:\FR\FM\07AUN1.SGM
07AUN1
]]>Agencies
[Federal Register Volume 84, Number 152 (Wednesday, August 7, 2019)]
[Notices]
[Pages 38633-38634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16889]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-N-4131, FDA-2018-N-0821, FDA-2013-N-0032, FDA-
2014-N-0801, FDA-2007-D-0429, FDA-2013-N-0013, and FDA-2008-D-0530]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved By OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection number expires
------------------------------------------------------------------------
FDA Adverse Event and Products 0910-0645 6/30/2022
Experience Reports; Electronic
Submissions............................
Investigation of Consumer Perceptions of 0910-0873 6/30/2022
Expressed Modified Risk Claims.........
Food Labeling: Notification Procedures 0910-0331 7/31/2022
for Statements on Dietary Supplements..
Export Notification and Recordkeeping 0910-0482 7/31/2022
Requirements...........................
Labeling of Nonprescription Human Drug 0910-0641 7/31/2022
Products Marketed Without an Approved
Application as Required by the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act................
Sanitary Transportation of Human and 0910-0773 7/31/2022
Animal Food............................
Guidance for Industry on Tropical 0910-0822 7/31/2022
Disease Priority Review Vouchers.......
------------------------------------------------------------------------
[[Page 38634]]
Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16889 Filed 8-6-19; 8:45 am]
BILLING CODE 4164-01-P
