Elemental Impurities in Animal Drug Products-Questions and Answers; Draft Guidance for Industry; Availability; Reopening of the Comment Period, 40524-40525 [2018-17525]
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40524
Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices
meetings. Please visit our website at
https://www.fda.gov/Advisory
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ucm111462.htm for procedures on
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17524 Filed 8–14–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Dated: August 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[Docket No. FDA–2017–N–0809]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that CRYSVITA
(burosamab-twza), manufactured by
Ultragenyx Pharmaceutical, Inc., meets
the criteria for a priority review
voucher.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9856,
email: althea.cuff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that CRYSVITA
(burosamab-twza), manufactured by
Ultragenyx Pharmaceutical, Inc., meets
SUMMARY:
daltland on DSKBBV9HB2PROD with NOTICES
[FR Doc. 2018–17527 Filed 8–14–18; 8:45 am]
Food and Drug Administration,
HHS.
ACTION:
the criteria for a priority review
voucher. CRYSVITA (burosamab-twza)
is indicated for the treatment of Xlinked hypophosphatemia in adult and
pediatric patients 1 year of age and
older.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about CRYSVITA
(burosumab-twza), go to the ‘‘Drugs@
FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
VerDate Sep<11>2014
18:28 Aug 14, 2018
Jkt 244001
Food and Drug Administration
[Docket No. FDA–2018–D–0943]
Elemental Impurities in Animal Drug
Products—Questions and Answers;
Draft Guidance for Industry;
Availability; Reopening of the
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; reopening
of the comment period.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
reopening the comment period for the
notice of availability that published in
the Federal Register on March 27, 2018.
In that document, FDA requested
comments on the draft guidance for
industry (GFI) #255 entitled ‘‘Elemental
Impurities in Animal Drug Products—
Questions and Answers.’’ The Agency is
taking this action in response to
requests for an extension to allow
interested parties additional time to
develop and submit comments.
DATES: FDA is reopening the comment
period on the notice of availability
published March 27, 2018 (83 FR
13134). Submit either electronic or
written comments on the draft guidance
by October 15, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
PO 00000
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Sfmt 4703
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• 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–
2018–D–0943 for ‘‘Elemental Impurities
in Animal Drug Products—Questions
and Answers.’’ 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
Dockets Management Staff 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
E:\FR\FM\15AUN1.SGM
15AUN1
Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
‘‘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
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests
for single copies of the draft guidance to
the Policy and Regulations Staff (HFV–
6), Center for Veterinary Medicine, Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Michael Brent, Center for Veterinary
Medicine (HFV–140), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0647,
michael.brent@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 27,
2018, FDA published a notice of
availability with a 60-day comment
period to request comments on draft GFI
#255 entitled ‘‘Elemental Impurities in
Animal Drug Products—Questions and
Answers.’’
This level 1 draft guidance is being
issued consistent with FDA’s good
VerDate Sep<11>2014
18:28 Aug 14, 2018
Jkt 244001
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on ‘‘Elemental
Impurities in Animal Drug Products—
Questions and Answers’’, providing
recommendations to sponsors regarding
the control of elemental impurities in
animal drug products, including all
dosage forms and routes of
administration. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
The Agency received two requests for
an extension of the comment period for
the draft guidance. The requestors
indicated they needed more time to
complete development of comments to
submit in response to the draft
guidance.
FDA has considered the requests and
is reopening the comment period for the
draft guidance for 60 days, until October
15, 2018. The Agency believes that a 60day reopening of the comment period
allows adequate time for interested
persons to submit comments to ensure
that the Agency can consider the
comments on this draft guidance before
it begins work on the final version of the
guidance.
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: August 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17525 Filed 8–14–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Division of Epidemiology and Disease
Prevention Epidemiology Program for
American Indian/Alaska Native Tribes
and Urban Indian Communities
Announcement Type: Competing
Supplement
Funding Announcement Number: HHS–
2018–IHS–EPI–0002
Catalog of Federal Domestic Assistance
Number: 93.231
PO 00000
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Fmt 4703
Sfmt 4703
40525
Key Dates
Application Deadline Date: September
12, 2018
Review Date: September 14–18, 2018
Earliest Anticipated Start Date:
September 30, 2018
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS)
Office of Public Health Support,
Division of Epidemiology and Disease
Prevention (DEDP), is accepting
applications for a cooperative agreement
for competitive supplemental funds to
enhance activities in the Epidemiology
Program for American Indian/Alaska
Native (AI/AN) Tribes and Urban Indian
communities.
This program is authorized under:
Section 317(k)(2) of the Public Health
Service Act [42 U.S.C. 247(b)(k)(2), as
amended]. Funding for this award will
be provided by: The Centers for Disease
Control and Prevention’s (CDC) National
Center for Emerging and Zoonotic
Infectious Diseases (NCEZID). The
authorities will be exercised by CDC
and through an Intra-Departmental
Delegation of Authority (IDDA) with
IHS to create a supplemental funding
opportunity for Tribal Epidemiology
Centers. The administration will be
carried out through an Intra-agency
Agreement (IAA) between CDC and IHS.
This program is described in the Catalog
of Federal Domestic Assistance (CFDA)
under 93.231.
Background
The Tribal Epidemiology Center (TEC)
program was authorized by Congress in
1998 as a way to provide public health
support to multiple Tribes and Urban
Indian communities in each of the IHS
Areas. Only current TEC grantees
serving Arizona Indian Tribes or Urban
Indian communities with confirmed
cases of Rocky Mountain spotted fever
(RMSF) between 2003–2017 are eligible
to apply for the competing
supplemental funding under this
announcement and must demonstrate
that they have complied with previous
terms and conditions of the TEC
program.
Positioned uniquely within Tribes
and Tribal or Urban Organizations,
TECs are able to conduct disease
surveillance, research, prevention and
control of disease, injury, or disability.
This allows them to assess the
effectiveness of AI/AN public health
programs. In addition, they can fill gaps
in data needed for the relevant
Government Performance and Results
Act and Healthy People 2020 measures.
Some of the existing TECs have already
E:\FR\FM\15AUN1.SGM
15AUN1
Agencies
[Federal Register Volume 83, Number 158 (Wednesday, August 15, 2018)]
[Notices]
[Pages 40524-40525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17525]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-0943]
Elemental Impurities in Animal Drug Products--Questions and
Answers; Draft Guidance for Industry; Availability; Reopening of the
Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; reopening of the comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is reopening
the comment period for the notice of availability that published in the
Federal Register on March 27, 2018. In that document, FDA requested
comments on the draft guidance for industry (GFI) #255 entitled
``Elemental Impurities in Animal Drug Products--Questions and
Answers.'' The Agency is taking this action in response to requests for
an extension to allow interested parties additional time to develop and
submit comments.
DATES: FDA is reopening the comment period on the notice of
availability published March 27, 2018 (83 FR 13134). Submit either
electronic or written comments on the draft guidance by October 15,
2018 to ensure that the Agency considers your comment on this draft
guidance before it begins work on the final version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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-2018-D-0943 for ``Elemental Impurities in Animal Drug Products--
Questions and Answers.'' 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 Dockets
Management Staff 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
[[Page 40525]]
``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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests for single copies of the draft
guidance to the Policy and Regulations Staff (HFV-6), Center for
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one self-addressed adhesive label to assist
that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Michael Brent, Center for Veterinary
Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-0647, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 27, 2018, FDA published a notice
of availability with a 60-day comment period to request comments on
draft GFI #255 entitled ``Elemental Impurities in Animal Drug
Products--Questions and Answers.''
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on
``Elemental Impurities in Animal Drug Products--Questions and
Answers'', providing recommendations to sponsors regarding the control
of elemental impurities in animal drug products, including all dosage
forms and routes of administration. It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.
The Agency received two requests for an extension of the comment
period for the draft guidance. The requestors indicated they needed
more time to complete development of comments to submit in response to
the draft guidance.
FDA has considered the requests and is reopening the comment period
for the draft guidance for 60 days, until October 15, 2018. The Agency
believes that a 60-day reopening of the comment period allows adequate
time for interested persons to submit comments to ensure that the
Agency can consider the comments on this draft guidance before it
begins work on the final version of the guidance.
II. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: August 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17525 Filed 8-14-18; 8:45 am]
BILLING CODE 4164-01-P