Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in Food and Drug Administration Advisory Committees; Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff; Availability; Extension of Comment Period, 65653-65655 [2016-22936]
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65653
Federal Register / Vol. 81, No. 185 / Friday, September 23, 2016 / Notices
CY 2013
ALJ Hearing .........................................................................
Judicial Review ....................................................................
III. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
Dated: September 7, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2016–23002 Filed 9–22–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10105]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; the accuracy of
the estimated burden; ways to enhance
the quality, utility, and clarity of the
information to be collected; and the use
of automated collection techniques or
other forms of information technology to
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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CY 2014
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minimize the information collection
burden.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by October 24, 2016.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 OR, Email:
OIRA_submission@omb.eop.gov.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
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CY 2015
CY 2016
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1,460
CY 2017
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1,500
$160
1,560
approved collection; Title of
Information Collection: National
Implementation of the In-Center
Hemodialysis CAHPS Survey; Use: Data
collected in the national
implementation of the In-center
Hemodialysis Consumer Assessment of
Healthcare Providers and Systems
(CAHPS) Survey will be used to: (1)
Provide a source of information from
which selected measures can be
publicly reported to beneficiaries as a
decision aid for dialysis facility
selection, (2) aid facilities with their
internal quality improvement efforts
and external benchmarking with other
facilities, (3) provide CMS with
information for monitoring and public
reporting purposes, and (4) support the
end-stage renal disease value-based
purchasing program. Form Number:
CMS–10105 (OMB control number:
0938–0926). Frequency: Occasionally;
Affected Public: Individuals or
households; Number of Respondents:
109,328; Total Annual Responses:
109,328; Total Annual Hours: 59,037.
(For policy questions regarding this
collection contact Julia Zucco at 410–
786–6670.)
Dated: September 20, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–22967 Filed 9–22–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1399]
Procedures for Evaluating Appearance
Issues and Granting Authorizations for
Participation in Food and Drug
Administration Advisory Committees;
Draft Guidance for the Public, Food
and Drug Administration Advisory
Committee Members, and Food and
Drug Administration Staff; Availability;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; extension
of comment period.
ACTION:
The Food and Drug
Administration (FDA) is extending the
comment period for the notice that
SUMMARY:
E:\FR\FM\23SEN1.SGM
23SEN1
65654
Federal Register / Vol. 81, No. 185 / Friday, September 23, 2016 / Notices
appeared in the Federal Register of June
29, 2016. In the notice, FDA requested
comments on ‘‘Procedures for
Evaluating Appearance Issues and
Granting Authorizations for
Participation in FDA Advisory
Committees; Guidance for the Public,
FDA Advisory Committee Members, and
FDA Staff’’ and on whether FDA should
request that each advisory committee
member, who receives an authorization
from FDA on an appearance issue so
that they may participate in an advisory
committee meeting, voluntarily publicly
disclose the authorization. The Agency
is taking this action due to errors
displayed on the FDA Web site
pertaining to this guidance.
DATES: FDA is extending the comment
period for the notice that published on
June 29, 2016 (81 FR 42363) by an
additional 60 days. Although you can
comment on any guidance at any time
(see 21 CFR 10.115(g)(5)), to ensure that
the Agency considers your comments on
this draft guidance before it begins work
on the final version of the guidance,
submit either electronic or written
comments on the draft guidance by
November 26, 2016.
ADDRESSES: You may submit comments
as follows:
sradovich on DSK3GMQ082PROD with NOTICES
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:
VerDate Sep<11>2014
18:22 Sep 22, 2016
Jkt 238001
• 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–
2016–D–1399 for ‘‘Procedures for
Evaluating Appearance Issues and
Granting Authorizations for
Participation in FDA Advisory
Committees; Guidance for the Public,
FDA Advisory Committee Members, and
FDA Staff.’’ 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’’
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
PO 00000
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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.
Submit written requests for a single
hard copy of the draft guidance entitled
‘‘Procedures for Evaluating Appearance
Issues and Granting Authorizations for
Participation in FDA Advisory
Committees; Guidance for the Public,
FDA Advisory Committee Members, and
FDA Staff’’ to the Advisory Committee
Oversight and Management Staff, Office
of Special Medical Programs, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Janine M. Morris, Office of Special
Medical Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5114, Silver Spring,
MD 20993–0002, 301–796–5706.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 29,
2016, FDA published a notice with a 90day comment period to request
comments on the draft guidance and
public disclosure of authorizations
described in this guidance.
The Agency has decided to allow for
a 60-day extension of the comment
period for the notice. The FDA Web site
that displayed the posting of this
guidance indicated, in error, that the
guidance was not open for comment.
The Agency was concerned that
individuals visiting the FDA Web site
and interested in providing comments
may not have known that the document
was available for comment under the
docket found at https://
www.regulations.gov.
FDA is therefore extending the
comment period for the notice for an
additional 60 days, until November 26,
2016. The Agency believes that a 60-day
extension allows adequate time for
interested persons to submit comments
without compromising timely
publication of the final guidance.
II. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet at either https://
E:\FR\FM\23SEN1.SGM
23SEN1
Federal Register / Vol. 81, No. 185 / Friday, September 23, 2016 / Notices
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’’).
www.fda.gov/RegulatoryInformation/
Guidances/ucm122045.htm or https://
www.regulations.gov.
Dated: September 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–22936 Filed 9–22–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–E–0072]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; FYCOMPA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
FYCOMPA and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
human drug product.
DATES: Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by November 22, 2016.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
March 22, 2017. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
sradovich on DSK3GMQ082PROD with NOTICES
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,
VerDate Sep<11>2014
18:22 Sep 22, 2016
Jkt 238001
Written/Paper Submissions
Submit written/paper submissions 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–
2014–E–0072 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; FYCOMPA.’’
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
PO 00000
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65655
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.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:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
E:\FR\FM\23SEN1.SGM
23SEN1
]]>Agencies
[Federal Register Volume 81, Number 185 (Friday, September 23, 2016)]
[Notices]
[Pages 65653-65655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22936]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-1399]
Procedures for Evaluating Appearance Issues and Granting
Authorizations for Participation in Food and Drug Administration
Advisory Committees; Draft Guidance for the Public, Food and Drug
Administration Advisory Committee Members, and Food and Drug
Administration Staff; Availability; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is extending the
comment period for the notice that
[[Page 65654]]
appeared in the Federal Register of June 29, 2016. In the notice, FDA
requested comments on ``Procedures for Evaluating Appearance Issues and
Granting Authorizations for Participation in FDA Advisory Committees;
Guidance for the Public, FDA Advisory Committee Members, and FDA
Staff'' and on whether FDA should request that each advisory committee
member, who receives an authorization from FDA on an appearance issue
so that they may participate in an advisory committee meeting,
voluntarily publicly disclose the authorization. The Agency is taking
this action due to errors displayed on the FDA Web site pertaining to
this guidance.
DATES: FDA is extending the comment period for the notice that
published on June 29, 2016 (81 FR 42363) by an additional 60 days.
Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 26, 2016.
ADDRESSES: You may submit 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, 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): 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-2016-D-1399 for ``Procedures for Evaluating Appearance Issues and
Granting Authorizations for Participation in FDA Advisory Committees;
Guidance for the Public, FDA Advisory Committee Members, and FDA
Staff.'' 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'' 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.
Submit written requests for a single hard copy of the draft
guidance entitled ``Procedures for Evaluating Appearance Issues and
Granting Authorizations for Participation in FDA Advisory Committees;
Guidance for the Public, FDA Advisory Committee Members, and FDA
Staff'' to the Advisory Committee Oversight and Management Staff,
Office of Special Medical Programs, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Janine M. Morris, Office of Special
Medical Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5114, Silver Spring, MD 20993-0002, 301-796-5706.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 29, 2016, FDA published a notice
with a 90-day comment period to request comments on the draft guidance
and public disclosure of authorizations described in this guidance.
The Agency has decided to allow for a 60-day extension of the
comment period for the notice. The FDA Web site that displayed the
posting of this guidance indicated, in error, that the guidance was not
open for comment. The Agency was concerned that individuals visiting
the FDA Web site and interested in providing comments may not have
known that the document was available for comment under the docket
found at https://www.regulations.gov.
FDA is therefore extending the comment period for the notice for an
additional 60 days, until November 26, 2016. The Agency believes that a
60-day extension allows adequate time for interested persons to submit
comments without compromising timely publication of the final guidance.
II. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet at either http:/
/
[[Page 65655]]
www.fda.gov/RegulatoryInformation/Guidances/ucm122045.htm or https://www.regulations.gov.
Dated: September 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22936 Filed 9-22-16; 8:45 am]
BILLING CODE 4164-01-P
