Pediatric Postmarketing Pharmacovigilance and Drug Utilization Reviews; Establishment of a Public Docket; Request for Comments, 11227-11228 [2017-03365]
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Federal Register / Vol. 82, No. 33 / Tuesday, February 21, 2017 / Notices
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Dated: February 15, 2017.
Janice M. Soreth,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2017–03364 Filed 2–17–17; 8:45 am]
BILLING CODE 4164–01–P
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11227
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration
Written/Paper Submissions
Submit written/paper submission as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
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• 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–
2017–N–0595 for ‘‘Pediatric
Postmarketing Pharmacovigilance and
Drug Utilization Reviews’’ that have
been posted on the FDA Web site at
https://www.fda.gov/
AdvisoryCommittees/
CommitteesMeetingMaterials/
PediatricAdvisoryCommittee/
ucm510701.htm between September 17,
2016, and February 24, 2017, but will
not be presented at the March 6–7, 2017
PAC meeting (82 FR 1345, January 5,
2017). 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
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made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
[Docket No. FDA–2017–N–0595]
Pediatric Postmarketing
Pharmacovigilance and Drug
Utilization Reviews; Establishment of a
Public Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA or Agency) is
establishing a public docket to collect
comments related to the pediatric
postmarketing pharmacovigilance and
drug utilization reviews of products
posted between September 17, 2016,
and February 24, 2017, on the FDA Web
site, but will not be presented at the
March 6–7, 2017, Pediatric Advisory
Committee (PAC) meeting. These
reviews are intended to be available for
review and comment by members of the
PAC, interested parties (such as
academic researchers, regulated
industries, consortia, and patient
groups), and the general public.
DATES: Submit either electronic or
written comments by March 10, 2017.
The docket will open on February 27,
2017, and remain open until March 10,
2017.
ADDRESSES: You may submit your
comments as follows:
SUMMARY:
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, you 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
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sradovich on DSK3GMQ082PROD with NOTICES
11228
Federal Register / Vol. 82, No. 33 / Tuesday, February 21, 2017 / Notices
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:
Kenneth Quinto, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5145, Silver Spring,
MD 20993, 240–402–2221, email:
kenneth.quinto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
responsible for protecting the public
health by assuring the safety, efficacy,
and security of human and veterinary
drugs, biological products, medical
devices, our Nation’s food supply,
cosmetics, and products that emit
radiation.
FDA is establishing a public docket
FDA–2017–N–0595 to receive input on
pediatric postmarketing
pharmacovigilance and drug utilization
reviews posted between September 17,
2016, and February 24, 2017, on the
FDA Web site at https://www.fda.gov/
AdvisoryCommittees/
CommitteesMeetingMaterials/
PediatricAdvisoryCommittee/
ucm510701.htm, but will not be
presented at the March 6–7, 2017, PAC
meeting (82 FR 1345, January 5, 2017).
FDA welcomes comments by members
of the PAC, as mandated by the Best
Pharmaceuticals for Children Act (Pub.
L. 107–109) and the Pediatric Research
Equity Act (Pub. L. 108–155), interested
parties (such as academic researchers,
regulated industries, consortia, and
patient groups), and the general public.
The docket will open on February 27,
2017, and remain open until March 10,
2017. These pediatric postmarketing
pharmacovigilance and drug utilization
reviews are for the following products:
• ALEVE PM (diphenhydramine
hydrochloride/naproxen sodium)
• ASTEPRO (azelastine hydrochloride)
• ECOZA (econazole nitrate)
• JETREA (ocriplasmin)
• QUARTETTE (levonorgestrel/ethinyl
estradiol and ethinyl estradiol)
VerDate Sep<11>2014
17:15 Feb 17, 2017
Jkt 241001
• TRUVADA (emtricitabine/tenofovir
disoproxil fumarate)
• XERESE (acyclovir/hydrocortisone)
Dated: February 15, 2017.
Janice M. Soreth,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2017–03365 Filed 2–17–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Nurse Faculty
Loan Program, Annual Performance
Report Financial Data Form
Health Resources and Services
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Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than April 24, 2017.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, 14N39, 5600 Fishers Lane,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference, in compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995.
Information Collection Request Title:
Nurse Faculty Loan Program, Annual
Performance Report Financial Data
Form, OMB No. 0915–0314—Revision.
Abstract: This collection request is for
continued approval of the Nurse Faculty
Loan Program’s revised Annual
SUMMARY:
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Performance Report (NFLP–APR)
Financial Data Form. The form was
previously titled as the Nurse Faculty
Loan Program, Annual Operating Report
(NFLP–AOR).
Section 846A of the Public Health
Service Act provides the Secretary of
HHS with the authority to enter into an
agreement with schools of nursing for
the establishment and operation of a
student loan fund to increase the
number of qualified nurse faculty.
Under the agreement, HRSA makes
awards to schools for the NFLP loan
fund, which must be maintained in a
distinct account. A school of nursing
makes loans from the NFLP account to
students enrolled full-time or, at the
discretion of the Secretary, part-time in
a master’s or doctoral nursing education
program that will prepare them to
become qualified nursing faculty.
Following graduation from the NFLP
lending school, loan recipients may
receive up to 85 percent NFLP loan
cancellation over a consecutive 4-year
period in exchange for service as fulltime faculty at a school of nursing. The
NFLP lending school collects any
portion of the loan that is not cancelled
and any loans that go into repayment
due to default, and deposits these
monies into the NFLP loan fund to make
additional NFLP loans.
Need and Proposed Use of the
Information: The online NFLP–APR
Financial Data Form is an online form
in the HRSA Electronic Handbooks
(EHBs) Performance Report module as
part of the NFLP, Bureau of Health
Workforce performance report (OMB
No: 0915–0061, expiration date of 6/30/
2019). The revised NFLP–APR financial
data form will collect less data from
applicants and will no longer include
nursing student demographic data. The
nursing student demographic data is
currently collected under OMB approval
number No: 0915–0061. The revised
NFLP–APR form will only collect
financial data to capture the NFLP loan
fund account activity related to
financial receivables, disbursements,
and borrower account data related to
employment status, loan cancellation,
loan repayment, and collections.
Participating schools will provide HRSA
with current and cumulative
information on: (1) NFLP loan funds
received, (2) number and amount of
NFLP loans made, (3) number and
amount of loans cancelled, (4) number
and amount of loans in repayment, (5)
loan default rate percent, (6) number of
NFLP graduates employed as nurse
faculty, and (7) other related loan fund
costs and activities.
The school of nursing must keep
records of all NFLP loan fund
E:\FR\FM\21FEN1.SGM
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Agencies
[Federal Register Volume 82, Number 33 (Tuesday, February 21, 2017)]
[Notices]
[Pages 11227-11228]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03365]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0595]
Pediatric Postmarketing Pharmacovigilance and Drug Utilization
Reviews; Establishment of a Public Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
establishing a public docket to collect comments related to the
pediatric postmarketing pharmacovigilance and drug utilization reviews
of products posted between September 17, 2016, and February 24, 2017,
on the FDA Web site, but will not be presented at the March 6-7, 2017,
Pediatric Advisory Committee (PAC) meeting. These reviews are intended
to be available for review and comment by members of the PAC,
interested parties (such as academic researchers, regulated industries,
consortia, and patient groups), and the general public.
DATES: Submit either electronic or written comments by March 10, 2017.
The docket will open on February 27, 2017, and remain open until March
10, 2017.
ADDRESSES: You may submit your 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, you 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 submission 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-2017-N-0595 for ``Pediatric Postmarketing Pharmacovigilance and
Drug Utilization Reviews'' that have been posted on the FDA Web site at
https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm between September 17, 2016,
and February 24, 2017, but will not be presented at the March 6-7, 2017
PAC meeting (82 FR 1345, January 5, 2017). 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 sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential''
[[Page 11228]]
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: Kenneth Quinto, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5145, Silver Spring, MD 20993, 240-402-2221, email:
kenneth.quinto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is responsible for protecting the public
health by assuring the safety, efficacy, and security of human and
veterinary drugs, biological products, medical devices, our Nation's
food supply, cosmetics, and products that emit radiation.
FDA is establishing a public docket FDA-2017-N-0595 to receive
input on pediatric postmarketing pharmacovigilance and drug utilization
reviews posted between September 17, 2016, and February 24, 2017, on
the FDA Web site at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm,
but will not be presented at the March 6-7, 2017, PAC meeting (82 FR
1345, January 5, 2017). FDA welcomes comments by members of the PAC, as
mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109)
and the Pediatric Research Equity Act (Pub. L. 108-155), interested
parties (such as academic researchers, regulated industries, consortia,
and patient groups), and the general public. The docket will open on
February 27, 2017, and remain open until March 10, 2017. These
pediatric postmarketing pharmacovigilance and drug utilization reviews
are for the following products:
ALEVE PM (diphenhydramine hydrochloride/naproxen sodium)
ASTEPRO (azelastine hydrochloride)
ECOZA (econazole nitrate)
JETREA (ocriplasmin)
QUARTETTE (levonorgestrel/ethinyl estradiol and ethinyl
estradiol)
TRUVADA (emtricitabine/tenofovir disoproxil fumarate)
XERESE (acyclovir/hydrocortisone)
Dated: February 15, 2017.
Janice M. Soreth,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2017-03365 Filed 2-17-17; 8:45 am]
BILLING CODE 4164-01-P