Pediatric Post-Marketing Pharmacovigilance and Drug Utilization Reviews; Establishment of a Public Docket; Request for Comments, 41969-41970 [2017-18690]
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Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices
6366, 10903 New Hampshire Ave.,
Silver Spring, MD 20993–0002, 240–
402–0493; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK30JT082PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Content of the Risk
Evaluation and Mitigation Strategies
Document Using Structured Product
Labeling; Draft Guidance for Industry.’’
FDASIA (Pub. L. 112–144), amended
the FD&C Act to add section 745A (21
U.S.C. 379k–1), entitled ‘‘Electronic
Format for Submissions.’’ Section
745A(a)(1) of the FD&C Act requires that
submissions under section 505(b), (i), or
(j) of the FD&C Act (21 U.S.C. 355(b), (i),
or (j)) and submissions under section
351(a) or (k) of the PHS Act (42 U.S.C.
262(a) or (k)) be submitted to FDA in
electronic format no earlier than 24
months after FDA issues final guidance
on electronic format for submissions. In
accordance with section 745A(a)(1) of
the FD&C Act, FDA is issuing this draft
guidance, announcing its determination
that submission types identified in the
guidance must be submitted
electronically in the format specified in
the guidance beginning 24 months after
the issuance of the final guidance.
This draft guidance (and the technical
specification documents it references)
describes how certain REMS documents
will be required to be submitted in
electronic format using Structured
Product Labeling (SPL) as outlined in
the FDA ‘‘Structured Product Labeling
(SPL) Implementation Guide with
Validation Procedures’’ (available at
https://www.fda.gov/downloads/
ForIndustry/DataStandards/
StructuredProductLabeling/
UCM321876.pdf). (FDA has verified the
Web site addresses, as of the date this
document publishes in the Federal
Register, but Web sites are subject to
change over time.) SPL is a Health Level
7 data standard used by FDA since
2005. For more information on how
FDA interprets section 745A(a) of the
FD&C Act, see the guidance for industry
‘‘Providing Regulatory Submissions in
Electronic Format—Submissions Under
Section745A(a) of the Federal Food,
Drug, and Cosmetic Act’’ (available at
https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/
UCM384686.pdf).
VerDate Sep<11>2014
17:43 Sep 01, 2017
Jkt 241001
Development of this guidance was
facilitated by completion of the
‘‘Pharmacy Systems Under REMS
Project: Standardizing REMS
Information for Inclusion Into Pharmacy
Systems Using Structured Product
Labeling (SPL).’’ More information on
this project—one of four predefined
priority projects that are a part of the
larger REMS Integration Initiative—can
be found in the report ‘‘Standardizing
and Evaluating Risk Evaluation and
Mitigation Strategies (REMS)’’ (available
at https://www.fda.gov/downloads/
ForIndustry/UserFees/Prescription
DrugUserFee/UCM415751.pdf).
II. Paperwork Reduction Act of 1995
This notice refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 314 have been approved
under OMB control number 0910–0001.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: August 23, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–18506 Filed 9–1–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4866]
Pediatric Post-Marketing
Pharmacovigilance and Drug
Utilization Reviews; Establishment of a
Public Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice, establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) is establishing a
public docket to collect comments
related to the pediatric post-marketing
pharmacovigilance and drug utilization
reviews of products posted between
March 11, 2017, and September 12,
SUMMARY:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
41969
2017, on FDA’s Web site but not
presented at the September 12, 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 October 20, 2017.
ADDRESSES: You may submit your
comments as follows. Please note that
late, untimely filed comments will not
be considered. Electronic comments
must be submitted on or before October
20, 2017. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
October 20, 2017. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
E:\FR\FM\05SEN1.SGM
05SEN1
mstockstill on DSK30JT082PROD with NOTICES
41970
Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices
• For written/paper comments
submitted to the Dockets Management
Staff, 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–4866 for the ‘‘Pediatric PostMarketing Pharmacovigilance and Drug
Utilization Reviews’’ that have been
posted on FDA’s Web site between
March 11, 2017, and September 12,
2017, but not presented at the
September 12, 2017, PAC meeting.
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff office
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 Dockets Management
Staff. 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’’ 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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
VerDate Sep<11>2014
17:43 Sep 01, 2017
Jkt 241001
and/or go to the Dockets Management
Staff, 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,
Docket No. FDA–2017–N–4866, to
receive input on pediatric postmarketing pharmacovigilance and drug
utilization reviews posted between
March 11, 2017, and September 12,
2017, available on FDA’s Web site at
https://www.fda.gov/
AdvisoryCommittees/
CommitteesMeetingMaterials/
PediatricAdvisoryCommittee/
ucm510701.htm, but not presented at
the September 12, 2017, PAC meeting.
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 number is FDA–2017–N–
4866. The docket will open on October
9, 2017, and remain open until October
20, 2017. These pediatric postmarketing pharmacovigilance and drug
utilization reviews are for the following
products from the following centers at
FDA:
Center for Biologics Evaluation and
Research
1. GRASTEK (Timothy Grass Pollen
Allergen Extract) Tablet for
Sublingual Use
2. ORALAIR (Sweet Vernal, Orchard,
Perennial Rye, Timothy, and
Kentucky Blue Grass Mixed Pollens
Allergen Extract) Tablet for
Sublingual Use
Center for Drug Evaluation and
Research
1. ALOXI (palonosetron hydrochloride)
2. ARNUITY ELLIPTA (fluticasone
furoate)
3. ASMANEX HFA and ASMANEX
TWISTHALER (mometasone furoate
inhalation)
4. CYMBALTA (duloxetine)
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
5. EMSAM (selegiline transdermal
system)
6. LATISSE (bimatoprost ophthalmic
solution) 0.03%
7. NAMENDA (memantine
hydrochloride) and NAMENDA XR
(memantine hydrochloride)
extended-release
8. PRIFTIN (rifapentine)
9. REYATAZ (atazanavir)
10. TACLONEX (betamethasone
dipropionate/calcipotriene hydrate)
Topical Suspension 0.064%/
0.005% and TACLONEX
(betamethasone dipropionate/
calcipotriene hydrate) Topical
Ointment 0.064%/0.005%
11. ZETONNA (ciclesonide)
Dated: August 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–18690 Filed 9–1–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: Apparatus for
Microarray Binding Sensors Having
Biological Probe Materials Using
Carbon Nanotube Transistors
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Commercialization
Patent License to practice the inventions
embodied in the Patents and Patent
Applications listed in the
SUPPLEMENTARY INFORMATION section of
this notice to Nanobernetics, LLC
(‘‘Nanobernetics’’) located in Maryland.
DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before September 20, 2017 will be
considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
Exclusive Commercialization Patent
License should be directed to: Jaime M.
Greene, Senior Licensing and Patenting
Manager, NCI Technology Transfer
Center, 9609 Medical Center Drive, Rm.
1E530 MSC 9702, Bethesda, MD 20892–
9702 (for business mail), Rockville, MD
20850–9702 Telephone: (240)-276–5530;
SUMMARY:
E:\FR\FM\05SEN1.SGM
05SEN1
Agencies
[Federal Register Volume 82, Number 170 (Tuesday, September 5, 2017)]
[Notices]
[Pages 41969-41970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18690]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-4866]
Pediatric Post-Marketing Pharmacovigilance and Drug Utilization
Reviews; Establishment of a Public Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice, establishment of a public docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is establishing a
public docket to collect comments related to the pediatric post-
marketing pharmacovigilance and drug utilization reviews of products
posted between March 11, 2017, and September 12, 2017, on FDA's Web
site but not presented at the September 12, 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 October 20,
2017.
ADDRESSES: You may submit your comments as follows. Please note that
late, untimely filed comments will not be considered. Electronic
comments must be submitted on or before October 20, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 20, 2017. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
[[Page 41970]]
For written/paper comments submitted to the Dockets
Management Staff, 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-4866 for the ``Pediatric Post-Marketing Pharmacovigilance
and Drug Utilization Reviews'' that have been posted on FDA's Web site
between March 11, 2017, and September 12, 2017, but not presented at
the September 12, 2017, PAC meeting. Received comments, those filed in
a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff office 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 Dockets Management Staff. 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'' 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 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, Docket No. FDA-2017-N-4866, to
receive input on pediatric post-marketing pharmacovigilance and drug
utilization reviews posted between March 11, 2017, and September 12,
2017, available on FDA's Web site at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm, but not presented at the
September 12, 2017, PAC meeting. 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
number is FDA-2017-N-4866. The docket will open on October 9, 2017, and
remain open until October 20, 2017. These pediatric post-marketing
pharmacovigilance and drug utilization reviews are for the following
products from the following centers at FDA:
Center for Biologics Evaluation and Research
1. GRASTEK (Timothy Grass Pollen Allergen Extract) Tablet for
Sublingual Use
2. ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky
Blue Grass Mixed Pollens Allergen Extract) Tablet for Sublingual Use
Center for Drug Evaluation and Research
1. ALOXI (palonosetron hydrochloride)
2. ARNUITY ELLIPTA (fluticasone furoate)
3. ASMANEX HFA and ASMANEX TWISTHALER (mometasone furoate inhalation)
4. CYMBALTA (duloxetine)
5. EMSAM (selegiline transdermal system)
6. LATISSE (bimatoprost ophthalmic solution) 0.03%
7. NAMENDA (memantine hydrochloride) and NAMENDA XR (memantine
hydrochloride) extended-release
8. PRIFTIN (rifapentine)
9. REYATAZ (atazanavir)
10. TACLONEX (betamethasone dipropionate/calcipotriene hydrate) Topical
Suspension 0.064%/0.005% and TACLONEX (betamethasone dipropionate/
calcipotriene hydrate) Topical Ointment 0.064%/0.005%
11. ZETONNA (ciclesonide)
Dated: August 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18690 Filed 9-1-17; 8:45 am]
BILLING CODE 4164-01-P