Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access; Public Meeting; Request for Comments; Extension of Comment Period, 43767-43768 [2017-19904]
Download as PDF
<![CDATA[
43767
Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices
(Response) As stated in the
supporting statements included in the
docket, FDA is working with a skilled
and experienced research contractor to
conduct the proposed study. In
addition, FDA scientific experts possess
skill and expertise in conducting such
research. Survey and focus group best
practices will be used, including
avoiding bias in questions due to
wording and question order and
developing a statistical analysis plan.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Portion of study
Number of
responses per
respondent
Total annual
responses
Screening for pretest ..............................................
Pretest ....................................................................
Screening for main data collection ........................
Main data collection ...............................................
762
100
19,082
2,500
1
1
1
1
762
100
19,082
2,500
Total ................................................................
........................
........................
........................
asabaliauskas on DSKBBXCHB2PROD with NOTICES
1 There
Average
burden per
response
0.033 (2
0.25 (15
0.033 (2
0.25 (15
minutes)
minutes)
minutes)
minutes)
Total hours
........
........
........
........
25
25
630
625
.....................................
1,305
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s burden estimate is based on
prior experience with research that is
similar to this proposed study.
Screening potential participants for the
2 pretests will occur with 762
respondents (487 adults and 275
adolescents) identified and recruited
through the Internet panel. This brief
screening will take an average of 2
minutes (0.033 hours) per respondent.
Each of the 2 pretests will consist of 50
respondents (34 adults and 16
adolescents) conducted during a single
session and take an average of 15
minutes (0.25 hours) per respondent.
Screening potential participants for the
main data collection will occur with
19,082 respondents (11,925 adults and
7,157 adolescents) identified and
recruited through the same Internet
panel as used for the pretests. This brief
screening will take an average of 2
minutes (0.033 hours) per respondent.
Recent national estimates of the
numbers of adolescent current cigarette
smokers, adolescents who are
susceptible to initiation of cigarette
smoking, young adult current cigarette
smokers, and older adult current
cigarette smokers informed the
estimates of 13.9 percent qualification
rate for adults and 11.6 percent
qualification rate for adolescents.
Applying these estimates and other
assumptions from previous experience
conducting similar studies to the
number of adolescents and adults to be
screened results in the desired sample
size for the main data collection of 2,500
participants, of which 1,667 will be
adults and 833 will be adolescents. The
main data collection will occur with
those 2,500 respondents during a single
session. The main data collection will
take an average of 15 minutes (0.25
hours) per respondent. The total
estimated burden is 1,305 hours (25
hours + 25 hours + 630 hours + 625
hours).
VerDate Sep<11>2014
17:12 Sep 18, 2017
Jkt 241001
Dated: September 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–19901 Filed 9–18–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–3615]
Administering the Hatch-Waxman
Amendments: Ensuring a Balance
Between Innovation and Access;
Public Meeting; Request for
Comments; Extension of Comment
Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments; extension of
comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
public meeting on ‘‘Administering the
Hatch-Waxman Amendments: Ensuring
a Balance Between Innovation and
Access’’ for which the notice of public
meeting appeared in the Federal
Register of June 22, 2017. In the notice
of public meeting, FDA requested
comments concerning administration of
the Hatch-Waxman Amendments to the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) to help ensure that the
intended balance between encouraging
innovation in drug development and
accelerating the availability to the
public of lower cost alternatives to
innovator drugs is maintained. The
Agency is taking this action in response
to a request for an extension to allow
SUMMARY:
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
interested persons additional time to
submit comments.
DATES: FDA is extending the comment
period on the notice of public meeting
published June 22, 2017 (82 FR 28493).
Submit either electronic or written
comments by November 17, 2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before November 17,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of November 17, 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, 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
E:\FR\FM\19SEN1.SGM
19SEN1
43768
Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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–
2017–N–3615 for ‘‘Administering the
Hatch-Waxman Amendments: Ensuring
a Balance Between Innovation and
Access; Public Meeting; Request for
Comments.’’ 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
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
VerDate Sep<11>2014
17:12 Sep 18, 2017
Jkt 241001
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.
FOR FURTHER INFORMATION CONTACT:
Philip Bonforte, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1668,
Silver Spring, MD 20993, 240–402–
6980, email: GenericDrugPolicy@
fda.hhs.gov.
In the
Federal Register of June 22, 2017, FDA
published a notice of public meeting
with a 60-day comment period to
request comments on the appropriate
balance between encouraging
innovation in drug development and
accelerating the availability to the
public of lower cost alternatives to
innovator drugs. Interested persons
were originally given until September
18, 2017, to comment.
Following publication of the June 22,
2017, notice of public meeting with
request for comments, FDA received
requests to allow interested persons
additional time to comment. The
requesters asserted that the time period
of 60 days was insufficient to respond
fully to FDA’s specific requests for
comments and to allow potential
respondents to thoroughly evaluate and
address pertinent issues.
FDA has considered the requests and
is extending the comment period for the
notice of public meeting until November
17, 2017.
SUPPLEMENTARY INFORMATION:
Dated: September 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–19904 Filed 9–18–17; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0508]
Registration and Product Listing for
Owners and Operators of Domestic
Tobacco Product Establishments;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a revised guidance for
industry entitled ‘‘Registration and
Product Listing for Owners and
Operators of Domestic Tobacco Product
Establishments.’’ This guidance is
intended to assist persons making
tobacco product establishment
registration and product listing
submissions to FDA.
DATES: The announcement of the
guidance is published in the Federal
Register on September 19, 2017.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time
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, 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:
Frm 00031
Fmt 4703
Sfmt 4703
E:\FR\FM\19SEN1.SGM
19SEN1
]]>Agencies
[Federal Register Volume 82, Number 180 (Tuesday, September 19, 2017)]
[Notices]
[Pages 43767-43768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19904]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-3615]
Administering the Hatch-Waxman Amendments: Ensuring a Balance
Between Innovation and Access; Public Meeting; Request for Comments;
Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments; extension of
comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the public meeting on ``Administering
the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and
Access'' for which the notice of public meeting appeared in the Federal
Register of June 22, 2017. In the notice of public meeting, FDA
requested comments concerning administration of the Hatch-Waxman
Amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
to help ensure that the intended balance between encouraging innovation
in drug development and accelerating the availability to the public of
lower cost alternatives to innovator drugs is maintained. The Agency is
taking this action in response to a request for an extension to allow
interested persons additional time to submit comments.
DATES: FDA is extending the comment period on the notice of public
meeting published June 22, 2017 (82 FR 28493). Submit either electronic
or written comments by November 17, 2017.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 17, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 17, 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, 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
[[Page 43768]]
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-2017-N-3615 for ``Administering the Hatch-Waxman Amendments:
Ensuring a Balance Between Innovation and Access; Public Meeting;
Request for Comments.'' 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 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: Philip Bonforte, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1668, Silver Spring, MD 20993, 240-402-
6980, email: GenericDrugPolicy@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 22, 2017,
FDA published a notice of public meeting with a 60-day comment period
to request comments on the appropriate balance between encouraging
innovation in drug development and accelerating the availability to the
public of lower cost alternatives to innovator drugs. Interested
persons were originally given until September 18, 2017, to comment.
Following publication of the June 22, 2017, notice of public
meeting with request for comments, FDA received requests to allow
interested persons additional time to comment. The requesters asserted
that the time period of 60 days was insufficient to respond fully to
FDA's specific requests for comments and to allow potential respondents
to thoroughly evaluate and address pertinent issues.
FDA has considered the requests and is extending the comment period
for the notice of public meeting until November 17, 2017.
Dated: September 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19904 Filed 9-18-17; 8:45 am]
BILLING CODE 4164-01-P
